Comparative Clinical Effects of Salvadora Persica Oral Rinse and A Phenolic Commercial Mouth Wash on Human Oral Health; An Invivo Randomized Trial

Aeeza Malik                           BDS, MDS

Marium Aftab                        MBBS

Malik Saleem Shaukat         BDS, MSc

Basil Khalid                           BDS, M.Phil

Marij Hameed                        BDS, MSc

Razia A. Ahmed                     MBBS, MCPS, MRCOG

OBJECTIVE: To compare the clinical effects of Salvadora persica oral rinse and commercial Phenolic mouth wash on oral health status of socially deprived madrasa girls after six months of a triple blind randomized clinical trial.
METHODOLOGY: Girls aged 18-22 years living permanently in a madrasa of Multan city were recruited. After determining the sample size and trial duration participants were randomized into group A and Group B and were provided with freshly Salvadora persica oral rinse and commercial Phenolic mouth washes respectively. Pre, mid and post-interventional examinations were executed by a single, blind and calibrated examiner using Turesky Quigley Hein Plaque and Loe and Silness Gingival indices. Statistical analysis was carried out by descriptive statistics, two sample independent t-tests and ANOVA. The p-value of <0.05 was considered significant at 95 % confidence level and 80% power.
RESULTS: Sixty subjects were enrolled for the present trial. The mean age of the participants was found out to be 21.5±0.76 years. No statistically significant difference was identified between the mean Plaque and Gingival scores of the two interventional groups at any of the examination phase.
CONCLUSION: Salvadora persica oral rinse is suggested to be equally effective as the commercial Phenolic mouth wash for the control of plaque deposition and prevention of gingival inflammation.
KEYWORDS: Dental plaque, Gingivitis, Miswak, Mouthwash
HOW TO CITE: Malik A, Aftab M, Shaukat MS, Khalid B, Hameed M, Ahmed RA. Comparative clinical effects of salvadora persica oral rinse and a phenolic commercial mouth wash on human oral health; An invivo randomized trial. J Pak Dent Assoc 2021;30(2):87-93.
DOI: https://doi.org/10.25301/JPDA.302.87
Received: 20 April 2020, Accepted: 14 February 2021

INTRODUCTION

Dental plaque, particularly its supra-gingival deposits has an established etiology for different periopathies.1 Increasing global trends of oral diseases has now imposed the use of both the mechanical and chemical plaque controlling therapies.2 The mechanical oral cleansing practices involve toothbrushes with dentifrices, however, chewing sticks or miswak has now proven its significant competence against effective plaque removal and gingival health.3-8
Miswak is now in its recompensing phase. Laboratory examinations have established that many favorable natural ingredients are present in almost all types of miswak sticks which provide both systemic and local oral curative effects. It has been reviewed that miswak particularly contains ascorbic and tannic acids which have verified effectiveness in healing inflamed and bleeding gums. Trimethylamine generate stimulatory effect on gingiva and Fluoride (1.0ug/ml) have a recognized dental hard tissue remineralization function.9-12 Literature reports the antiperiopathic and anti- carious property of miswak by reducing plaque formation;13-14 also it has an established antimicrobial effect against Streptococcus Mutans and Fecalis which are the most vulnerable microorganisms of oral cavity.12&15 Moreover, different local chemotherapeutic agents are also used as an adjunct to mechanical cleansing predominantly where gingival inflammation is more prevalent.1
The widely known and recommended oral rinse includes Phenolic containing salicylic acid and Chlorhexidine gluconate mouth washes, which have evidently reported their anti-bacterial and anti-plaque efficacy.1,16-17 In the current study Listerine mouth rinse brand was choosen because of its affordability and easy on counter availability in Pakistan. Listerine mouth rinse enclose a blend of phenolic compounds which is reported to have high bactericidal properties and has great ability to restrict the inflammatory diseased processes of oral soft tissues. A nine month clinical study also demonstrated that Phenolic mouth wash has a dramatic effect on plaque toxic activity.17 Keeping in mind the limited awareness and affordability of people in developing countries to use Phenolic and similar products which are prescribed frequently as treatment for highly prevalent periopathies, importance should be given to the comparison of these products to natural and cheaper alternatives whose affordability and availability are never
argued. Also, to date, the reported in-vivo data on such comparison is really sparse. Hence, the testing null hypothesis of this study was “no difference will be observed in the oral health status of subjects using Salvadora persica oral rinse or Phenolic mouth wash”. The objective of this experimental study was to compare the clinical effects of Salvadora persica oral rinse and commercial Phenolic mouth wash on oral health status of socially deprived madrasa girls after six months of a triple blind randomized clinical trial.

METHODOLOGY

Approval to conduct this trial was attained from the official Institutional Review Board of Multan Medical & Dental College, Multan (IRB/MDC/005-24-07-2019). This triple blind randomized controlled trial over a span of six months (August 2019 – January 2020) was conducted in the Madrasa for girls, Multan city. Present trial is based upon the guidelines of CONSORT (Consolidated Standards of Reporting Trials)
and has strickly followed the checklist provided by the CONSORT.18 Also, “The ethical standards of World Medical Association for human experimentation 2008 version of the Helsinki Declaration” has been followed in the current study.19 The sample size and trial duration were considered using “The American Dental Association, Acceptance Program Guidelines for Chemotherapeutic Products for Control of Gingivitis, 2009”.20-22
Written permission was obtained from the madrasa administration and verbal consent after notifying about the intention and purpose of the study was attained from all the girls present in the madrasa. Participants/girls with any medical or dental disease, dental prosthesis, those taken antibiotics in last 6 months, those received any periodontal therapy in last 3 months were excluded, while, participants
with at least 10 sites of chronic mild gingivitis with bleeding on probing but not having periodontal pockets of greater than 3mm were included in the trial. (Figure 1)

Figure 1: Flow Diagram of the Phases of the Randomized Trial, According to the Consolidated Guidelines for Reporting Trials (CONSORT)

 

PRE-TRIAL PHASE

Earlier the commencment of this trial, a pre-trial workshop was led where the participants of the two groups were given certain instructions to standardize each activity of the trial. This was done by inculcating all subjects to uniformly use similar quantity (15 ml) of the given mouthwash for one minute twice daily (after breakfast and before going to bed). They were instructed to store the given bottles in refrigerators
having temperature around 40C. They were also advised to brush their teeth with the same brushing technique to control the plaque deposition during the trial period. For this the most appropriate and recommended brushing technique (Bass method) was demonstrated individually to every participant on tripodents. Participants were also shown the related video of Bass method on multimedia. Later the
participants were asked to reproduce the taught brushing technique on the own teeth in front of a mirror and in presence of the same single examiner/instructor. All the participants were asked to apply toothpaste on full length of toothbrush and brush teeth two times a day (after breakfast and before going to bed) for 2 minutes. All these standards were strictly reinforced through regular telephonic calls. Feed backs were
also obtained from the administration and supervisors of the Madrassa.

TRIAL PHASE

For this trial the participants were the cohort of young girls between age 18-22 years living permanently in the same madrasa. A total of 100 girls were enrolled in the madrasa and all of them were assessed for eligibility. However, 40 girls did not meet the inclusion criteria and were therefore excluded from the trail. Ultimately, 60 participants were included for the present trial. These 60 girls were then randomly allocated to two interventional groups (n=30 in Group A and n=30 in Group B) by means of Simple Random Sampling using random number table. The principal investigator (AM) who was not going to be concealed or blind to the group assignment, enrolled and randomized the participants. Particulars of the participants who were randomized was sealed off in sequentially numbered, opaque, sealed envelopes (SNOSE). The participants, examiners and the data analysts (outcome assessor) were blind to the intervention allocation (Figure 1). Each participant of Group A and B was weekly provided with a coloured coded bottle. The rinses in all the bottles had same color so that none of the participant may not recognize the type of mouthwash and remain blinded to the intervention. Each coded bottle contained 500 ml of mouth wash. Freshly prepared Salvadora Persica oral rinse was then given to Group A, while Group B was provided with Commercial Phenolic mouthwash.

EXAMINATION PHASE

Dental examination was later conducted at baseline, then after 3 and 6 months, that is, Pre-Interventional, Mid Intervention and Post-Interventional phases respectively. It was executed on inclined chairs in day light using a sterilized dental mirror and CPITN (Community Periodontal Index of Treatment Need) probe. This probe has a ball ended tip with a diameter of 0.5mm. This probe have two coloured bands of 2mm graduations each, one at 3.5 to 5.5mm and second at 8.5 to 11.5mm. These bands determine the bleeding on probing which correspond to respective gingival score as per Loe and Silness Gingival index (1962).25,26 This index which was used as a tool for examination which is universally accepted to determine the oral gingival status. Dental plaque was identified and measured using commercialy available plaque disclosing lozenges. These lozenges were biocompatible and had Iodine as basic chemical compound.
The participants were asked to chews this lozenge, swishes it all over the teeth for 30-60 seconds and then rinse it completely. The coloured plaque was then scored according to Turesky Quigley Hein Plaque index (1962).24 All these dental examinations were executed by a single, blind, trained and calibrated examiner.The examiner was trained in the Out Patient Department of Multan Dental College by the Professor of Periodontology by undergoing multiple exersicing of using the trial diagnostics, indices and instruments on selected patients. These selected patients were the cohorts having both normal and inflamed gingiva.
After multiple exercises, the examiner was calibrated for the two indices to be measured. Later, the intra-examiner reliability of the single examiner was achieved on 10% of total trial sample in the madrasa campus. These 10% of the trial participants were evaluated just to obtain the examiner’s reliability and were not included in the final trial. The mean Kappa value of intra-examiner reliability determined on
these 10% of the participants was identified as 0.95.

LABORATORY PHASE

The Salvadora Persica oral rinse was prepared in the Environmental Research Department of Bahauddin Zikria University, Multan city. One senior person nominated by this department was contacted and provided with all the necessary documents of the current study including the referenced methodology (Standard Operating Procedures) to be stricktly followed. Samples of fresh vacuum packed Salvadora Persica (Peelu miswak) sticks were collected from local market. These sticks were then being cut into small pieces and allowed to dry at room temperature for two days. Then these were ground to powder. Successive 10 g quantity was put into a sterile screw capped bottle to which 100 ml of sterile deionized distilled water was added. The extract was allowed to soak for 48 hours at 4°C and then centrifuged at 2000 rpm for 15 minutes. The supernatant was passed through filter paper (0.45 m pore size) and the extract was prepared at 50% concentration.23 This procedure was performed several times by the same person each time during the study period of 6 months. The miswak extract was suggested by the laboratory to be consumed within one week, the provision was made on weekly basis for 6 months.

STATISTICAL ANALYSIS

Data collected was subjected to statistical analysis using Statistical Package for Social Sciences (SPSS) Version 21 software and has been described in terms of Mean and standard deviations. As the data was normally distributed, two sample independent t-test was employed to see the difference of the mean plaque scores as well as the gingival scores of the two groups at baseline, 3 months and 6 months of the examination. Considering the comparisions at three intervals Analysis of Variance (ANOVA) test was also conducted. Intra-examiner reliability was calculated using Cohen’s Kappa. The p-value of <0.05 was considered as statistically significant at the 95% confidence level as the power level was kept 80%.

RESULTS

Figure 1 demonstrates the total number of participants assessed for eligibility (n=100) and those who were excluded (n=40). Therefore, 60 subjects were enrolled for the present trial, 30 in each of the two interventional group. The follow-up attrition was 12% as 7 subjects lost to follow-up during the total trial period of 6 months. The mean age of the participants was found to be 21.5 ± 0.76 years. Comparative mean plaque scores and mean gingival scores for both the interventional groups at pre-, mid- and post-examination phases are demonstrated in Table 1. The same table illustrates that no statistically significant difference was identified between the mean plaque and gingival scores of two interventional groups at any of the examination phase.

Table 1: Comparative Mean Plaque and Gingival Scores of Two Groups at Pre, Mid and Post Examination Phases

*p-value = Level of significance of change in mean plaque and gingival scores obtained e mploying independent t-test

Table 2 describes the findings of ANOVA which suggest that no statistical difference was found between the the two interventional groups when their plaque and gingival scores were compared at three different examination phases

Table 2: Analysis of Variance between the Two Groups at Pre, Mid and Post Examination Phases

*F = variance between mean plaque and gingival scores obtained employing ANOVA test.

DISCUSSION

This experimental study was conducted to evaluate the comparative effectiveness of the Salvadora persica oral rinse and commercial Phenolic mouth wash on oral health status of selected socially deprived population and has identified no difference in the clinical efficacies of the two interventions in the given trial duration of 6 months. The present trial has followed “the American Dental Association (ADA) guidelines to conduct clinical studies for the assessment of chemotherapeutic agents”. ADA suggests that the clinical advantage of plaque control may be demonstrated by a significant reduction in gingivitis. It
also explains that products meant to achieve their anti-gingivitis effectiveness through plaque reduction should determine significant reductions in both plaque and gingival scores at the end of the study.20-22 This trial has accomplished all these given commendations when mean plaque and gingival scores were compared from baseline to 6 months. Phenolic mouth wash was chosen for this trial as other commercial mouthwashes like chlorhexidine formulations, which has more proven anti-gingivitis efficacy is only recommended for short periods.27,28 However, phenolic antiseptic rinses can be used for long terms. They destroys and constrains the growth of both gram-positive and gramnegative colonoies of bacteria. Phenolic group of mouth washes are also reported to have efficient antimicrobial activity which not only abolishes bacterial cell surface and prevents the growth of oral bacterial biofilm but also increases the time of bacterial regrowth.17 Salvadora persica miswak was selected in this trial to study its comparative antimicrobial activity with phenolic compounds because of its easy availability and affordability in Pakistan. Also, Salvadora persica miswak has an established oral therapeutic properties, acceptable taste and odor and significant antiplaque efficacy.3-8,29&30
The results of the present study are in line with the study of Patel who has reported beneficial anti-gingivitis effect of miswak juice.31 This study is also in accordance with the study of Khalid Almas about the effects of Chlorhexidine and miswak extract on healthy and periodontally involved human dentin and concluded that Chlorhexidine 0.2% and miswak extract 50% had a similar effect on dentin specimens.32 Another double-blind clinical trial by Khalessi had studied the comparative antimicrobial activity of Persica and Chlorhexidine against certain pathogens in periodontal tissues such as Porphyromonas gingivalis and Aggregatibacter actinomycetemcomitans in vitro. The study reported superior antimicrobial activity of Persica which is in accordance with our study.33 Another study of Babol studied the effect of chewing gum containing Persica extract on periodontal health in a double-masked, randomized trial and reported significant reduction of gingival and bleeding scores of subjects using chewing gums having miswak extract compared with other placebo groups.34 This is significant to be reported to support the current study as it explains the healthy outcomes of miswak extracts on oral tissues and therefore validate the effect of miswak extract.
Miswak use may also be promoted in stick form as the previously published literature supports both the mechanical and chemical efficacy of miswak.31,32,-34 However, mechanical cleansing efficacy of miswak has reported high plaque and gingival scores in few of the subjects using miswak stick when matched with those using toothbrushes. In this context, few investigations have likewise discovered that those subjects who were using chewing sticks and were found to have poor oral hygiene scores, was probably a consequense of improper cleansing techniques in using chewing sticks by the subjects in that particular study.35 Therefore, it may be suggested that if miswak stick is used with appropriate technique, it can efficiently provide anti-plaque and antigingivitis effects both mechanically and chemically. Currently, several over the counter mouthwashs are available in Pakistan, and none of them contain miswak extract which has an established therapeutic remedy for the control of plaque and gingivitis.3-8 This study strongly recommends the incorporation of miswak extract in local mouth washes not only because of its natural pharmaceutical oral health benefits, high fluoride content but for being a cheaper product for the population of any developing country having financial constraints and limited oral health care amenities. However, more controlled trials are needed to establish miswak as a therapeutic medicament both mechanically and chemically for the prevention and control of periodontal diseases.

CONCLUSION

This trial has revealed no statistically significant difference in the oral health status of the two comparative groups, suggesting that Salvadora persica (miswak) oral rinse may be equally effective as the commercial Phenolic mouth wash for controlling dental plaque and preventing gingival inflammation.

FUTURE RECOMMENDATIONS

Some of the confounding variables responsible for the development of plaque and gingivitis such as few systemic undiagnosed diseases, disturbed hormones, genetics, drugs, malnutrition etc. which may influence the signs and symptoms of the disease must also be evaluated in future studies. Also some sort of objective assessment of the effectiveness of brushing amongst the study participants in all groups may be included in the future trials. Using a third group of true controls (not using any mouth wash but only brushing in the recommended way) in future will also increase the credibility of the study.

CONFLICT OF INTEREST

No conflict of interest was identified among the authors that may profit or loss in the publication of this paper.

ACKNOWLEDGEMENT

Heartfelt thanks to all the study participants from the Madrasa and Multan and Environmental Research Department of Bahauddin Zikria University, Multan.

REFERENCES

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  11. Dahiya PD, Kamal RK, Luthra RP, Mishra RM and Saini GS. Miswak: A Periodontist Perspective. J Ayurveda Integr Med. 2012;3:184-87. https://doi.org/10.4103/0975-9476.104431
  12. Almas, K. The antimicrobial effects of extracts of Azadirachta Indica (NEEM) and Salvadora Persica (Arak) chewing sticks. Ind J Dent Res.1999;10:23-6.
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  14. Singh A, Purohit B. Tooth brushing, oil pulling and tissue regeneration: a review of holistic approaches to oral health. J Ayurveda Integr Med. 2011;2:64-8. https://doi.org/10.4103/0975-9476.82525
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  30. Farooqi MIH, Srivastava JG. The toothbrush tree (Salvadora persica). Q J Crude Drug Res. 1968;8:1297-99. https://doi.org/10.3109/13880206809083356
  31. Patel PV, Shruthi S, & Kumar S. Clinical effect of miswak as an adjunct to tooth brushing on gingivitis. J Ind Soc Periodontol. 2012;16:84-8 https://doi.org/10.4103/0972-124X.94611
  32. Almas K. The effects of Salvadora persica Extract (Miswak) and chlorahexidine gluconate on Human Dentin: A SEM study. J. Contemp. Dent. Prac. 2002; 3:27-35. https://doi.org/10.5005/jcdp-3-3-27
  33. Khalessi AM, Pack AR, Thomson WM, Tompkins GR. An in vivo study of the plaque control efficacy of Persica: a commercially available herbal mouthwash containing extracts of Salvadora persica.
    Int Dent J. 2004; 54:279-83. https://doi.org/10.1111/j.1875-595X.2004.tb00294.x
  34. Babak Amoian, Ali Akbar Moghadamnia, Soozan Barzi, Sepideh Sheykholeslami, Afsaneh Rangiani. Salvadora persica extract chewing gum and gingival health: improvement of gingival and probe-bleeding
    index. Complement Ther Clin Pract. 2010; 16:121-23. https://doi.org/10.1016/j.ctcp.2009.11.002
  35. Gazi M, Saini T, Ashri N, Lambourne A. Meswak chewing stick versus conventional tooth- brush as an oral hygiene aid. Clin Prev Dent. 1990;12:19-23.

1. Assistant Professor, Department of Community Dentistry, Multan Medical & Dental College, Multan, University of Health Sciences, Lahore. Pakistan. Pakistan.
2. Ex-Student and House Officer, Dow University of Health Sciences, Karachi, Pakistan.
3. Associate Professor, Department of Science of Dental Materials, Multan Medical & Dental College, Multan, University of Health Sciences, Lahore. Pakistan.
4. Assistant Professor, Department of Oral Pathology, Multan Medical & Dental College, Multan, University of Health Sciences, Lahore.
5. Assistant Professor, Department of Periodontology, Multan Medical & Dental College, Multan, University of Health Sciences, Lahore.
6. Associate Professor, Department of Family & Community Medicine, King Khalid University, Abha, Saudi Arabia.
Corresponding author: “Dr. Aeeza Malik” < aeezamalik@gmail.com >

 

Comparative Clinical Effects of Salvadora Persica Oral Rinse and A Phenolic Commercial Mouth Wash on Human Oral Health; An Invivo Randomized Trial

Aeeza Malik                           BDS, MDS

Marium Aftab                        MBBS

Malik Saleem Shaukat         BDS, MSc

Basil Khalid                           BDS, M.Phil

Marij Hameed                        BDS, MSc

Razia A. Ahmed                     MBBS, MCPS, MRCOG

OBJECTIVE: To compare the clinical effects of Salvadora persica oral rinse and commercial Phenolic mouth wash on oral health status of socially deprived madrasa girls after six months of a triple blind randomized clinical trial.
METHODOLOGY: Girls aged 18-22 years living permanently in a madrasa of Multan city were recruited. After determining the sample size and trial duration participants were randomized into group A and Group B and were provided with freshly Salvadora persica oral rinse and commercial Phenolic mouth washes respectively. Pre, mid and post-interventional examinations were executed by a single, blind and calibrated examiner using Turesky Quigley Hein Plaque and Loe and Silness Gingival indices. Statistical analysis was carried out by descriptive statistics, two sample independent t-tests and ANOVA. The p-value of <0.05 was considered significant at 95 % confidence level and 80% power.
RESULTS: Sixty subjects were enrolled for the present trial. The mean age of the participants was found out to be 21.5±0.76 years. No statistically significant difference was identified between the mean Plaque and Gingival scores of the two interventional groups at any of the examination phase.
CONCLUSION: Salvadora persica oral rinse is suggested to be equally effective as the commercial Phenolic mouth wash for the control of plaque deposition and prevention of gingival inflammation.
KEYWORDS: Dental plaque, Gingivitis, Miswak, Mouthwash
HOW TO CITE: Malik A, Aftab M, Shaukat MS, Khalid B, Hameed M, Ahmed RA. Comparative clinical effects of salvadora persica oral rinse and a phenolic commercial mouth wash on human oral health; An invivo randomized trial. J Pak Dent Assoc 2021;30(2):87-93.
DOI: https://doi.org/10.25301/JPDA.302.87
Received: 20 April 2020, Accepted: 14 February 2021
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Non-Surgical Periodontal Therapy Improves Clinical Outcomes in Patients with Chronic Periodontitis Independent of the Use of Nigella Sativa Oil or Normal Saline Mouthwash; Randomized Controlled Trial

Ghazala Hassan                BDS

Sarah Ghafoor                   BDS, PhD, MPHE, BSc

Saira Atif                             BDS, M.Phil, BSc

Saima Chaudhry                BDS, PhD, MME, BSc

Zubair Ahmed Khan          BDS, MCPS

OBJECTIVES: Chronic periodontitis (CP) is an inflammatory disease of microbial origin that harms the health of the oral tissues. The objective of this study was to analyz the effects of Nigella sativa oil mouthwash given for two weeks after non-surgical therapy in patients with CP.
METHODOLOGY: This study was a parallel-arm randomized controlled trial that was conducted after ethical approval and registered with clinicaltrials.gov. The trial followed the guidelines of CONSORT and triple blinding was ensured. A total of fifty voluntary participants, after giving consent and being evaluated for clinical parameters of CP that included Periodontal Pocket Depth (PPD), CAL (Clinical Attachment Loss), PI (Plaque Index) and BoP (Bleeding on Probing) were divided into a control group and a treatment group. Both groups underwent scaling and root planning and were given normal saline solution or Nigella sativa oil respectively to be used as mouthwash daily for two weeks. The clinical parameters were recorded after two weeks and data was analyzed using SPSS (version 25.0).
RESULTS: It was noted that a statistically significant change was found in the pre-treatment and post-treatment values of all CP parameters in both the groups after the use of normal saline and Nigella sativa oil mouthwash. No statistically significant results were obtained when clinical parameters were evaluated between the two groups.
CONCLUSION: The clinical periodontal parameters of PI, CAL, PPD and BoP improved in both study groups two weeks following non-surgical periodontal therapy irrespective of the Nigella Sativa oil-based mouthwash or normal saline-based mouthwash used. It is suggested that either both types of mouthwashes had a beneficial effect or sub-gingival ultrasonic instrumentation itself was enough for improvement of periodontal health irrespective of the mouthwash used.
KEYWORDS: Nigella sativa, Chronic periodontitis, Normal Saline, Oral Health, Dental, Non-surgical Periodontal Therapy
HOW TO CITE: Hassan G, Ghafoor S, Atif S, Chaudhry S, Khan ZA. Non-Surgical periodontal therapy improves clinical outcomes in patients with chronic periodontitis independent of the use of nigella sativa oil or normal saline mouthwash; randomized controlled trial. J Pak Dent Assoc 2021;30(2):81-86.
DOI: https://doi.org/10.25301/JPDA.302.81
Received: 15 December 2020, Accepted: 31 January 2021

INTRODUCTION

Chronic periodontitis (CP), an inflammatory condition of supporting structures of teeth, that affects more than 75% of the adult population of Pakistan .1-3 CP presents with clinical attachment loss (CAL) leading to periodontal pockets and bleeding on probing (BoP). In general, an individual can have periodontitis when one or more sites around the tooth have CAL >1 mm, periodontal pocket depth (PPD) of >3 mm and inflammation leading to BoP.4 CP is initiated and mediated through the commensal oral micro-biota that forms the dental plaque.
This micro-biota interacts with the immune defense mechanisms of the individual and propagates disease which if untreated leads to tooth loss and systemic inflammation.5 Individuals with CP are at a higher risk of many other disease conditions including cardiovascular disease, diabetes mellitus, preterm birth, Alzheimer’s disease chronic obstructive pulmonary disease and kidney disease.6
The goal of the periodontal treatment is to limit microbial invasion into periodontal tissues by controlling plaque and calculus deposits at early stages through scaling and/or root planning, followed by at home use of teeth-cleaning aids such as dentifrices and mouthwashes.7
Medicinal plants have been used for over hundreds of years as a holistic approach for cure of oral and dental diseases. Among the various medicinal herbs that are being widely used in maintaining oral health such as gum arabic, aloe vera, miswak, clove, neem etc, Nigella sativa (NS) also known as “kalongi” in Urdu language is an herbal plant that is often used as a home remedy for dental problems. Its active ingredient known as thymoquinone (TQ) gives it anti-viral, anti-inflammatory, anti-microbial and anti-parasitic properties.8
Previously, the role of TQ in rat models of CP has been explored where its administration reduced the severity of gingivitis and decreased alveolar bone resorption.9 Rats treated with TQ in drinking water or an oral gel were shown to have significantly lower periodontal indices as compared to control groups with no sign of inflammation on mandibular histology in the treatment group.10 The antimicrobial effects of NS against periodontal pathogens are also documented in literature indicating its possible role in the healing of CP.11,12 Therefore, it was hypothesized that there will be a difference between the use of NS oil-based and normal saline-based mouthwashes in terms of improvement in periodontal parameters two weeks after non-surgical periodontal therapy in patients suffering from CP.

METHODOLOGY

We have recently published the detailed methodology of this parallel-arm randomized controlled trial that was conducted at Department of Periodontology, FMH College of Medicine & Dentistry, Lahore Pakistan from January 2018 to June 2019, after ethical approval from the institutional ethical committee vide letter number FMH07-2017-IRB-268-F.13,14 The trial was registered with clinicaltrials.gov (NCT03270280) and followed the CONSORT guidelines.13,14 The duration of clinical use of mouthwash in this trial was two weeks and details regarding inclusion and exclusion criteria, consent approval, blinding procedure, flow charts etc have been described in our recent publications.13,14 The sample size was calculated by using the following comparison of mean formula keeping the power of study at 90% and and 5% margin of error based on published values of one of the variables (MMP-8) of the study.13,15

 

Where, n= number of samples in each groups, Z1- = Z score for power of study at 90%= 1.28, Z1- / = Z score for level of significance at 5%= 1.96. The calculated sample size in each group came out to be eighteen; however, sample size was increased to twenty-five participants in each group in order to compensate for the potential drop-outs. 13 A total ninety-three participants were initially screened for CP using the clinical periodontal parameters of plaque index (PI), CAL, PPD and BoP. Among these, fifty individuals having CP were selected as per the inclusion criteria13,14 and were randomized into two groups of twenty-five participants each, as per the sample size, in which treatment group received NS oil-based mouthwash and the control group received normal saline solution as mouthwash.13,14
The recommended dose of NS oil-based mouthwash for this study was calculated as 500 mg (five ml or fifty-five drops) of NS oil, as per previously published. 13,14,16 Same amount was recommended for normal saline solution that was designated as a placebo in this study. A total of eighty ml of NS oil and the normal saline mouthwashes were dispensed in amber bottles which were sequentially numbered and triple blinding was ensured to avoid any bias in the study. 13,14
All CP patients underwent scaling and root planning therapy and were instructed to apply five ml of the mouthwash on the gingivae with the help of a clean and dry finger, twice daily for two weeks. 13,14 All participants were instructed not to eat or drink for approximately thirty minutes after the use of the mouthwash. No other commercially available mouthwash or any other adjunct therapy was advocated to any of the participant. After using mouthwash for two weeks, all study participants were asked to report for re-assessment of clinical periodontal parameters. 13,14

STATISTICAL ANALYSIS

All the collected data was coded and analyzed using IBM Statistical Package for the Social Sciences (SPSS, Version 25.0). The variables of age, CAL, PPD, PI, and BoP were presented as means and standard deviations (SDs). Wilcoxon signed-rank test was used to compare the pre-treatment and post-treatment changes in mean values of these clinical periodontal parameters within both the groups while Mann Whitney-U test was computed to observe the differences in periodontal parameters between the two study groups. For all analysis, p value of < 0.05 was considered statistically significant.

RESULTS

As reported previously, a total of forty participants (twenty in each group) completed the study till the end hence a loss to follow-up of twenty percent was observed. The mean of age of the study participants in treatment group and control group was 36.39±8.14 years and 38.27±7.44 years respectively. 13,14 The pre-treatment and post-treatment changes in the mean values of clinical CP parameters within both the groups were analyzed. It was noted that a statistically significant difference was found in the pre-treatment and post-treatment values of all CP parameters in both the groups (Table 1). This indicated that the clinical CP parameters improved in both the treatment and the control groups irrespective of the mouthwash used.

Table 1: Comparison of Clinical Parameters of Chronic Periodontitis before and After Treatment within Each Study Group

Upon comparison of clinical parameters within the group, a statistically significant value is observed for all clinical parameters in both the groups. PPD: Periodontal Pocket Depth, CAL: Clinical Attachment Loss, PI: Plaque Index, BoP: Bleeding on Probing. * Level of Significance.

Table 2: Comparison of Pre-treatment and Post-treatment Values of Clinical Parameters of Chronic Periodontitis between Treatment and Control groups

PPD: Periodontal Pocket Depth, CAL: Clinical Attachment Loss, PI: Plaque Index, BoP: Bleeding on Probing. All the clinical parameters of pre-treatment groups except BoP are almost similar in both the study groups. *Level of significance

Using Mann Whitney-U test (Table 2) the mean values of clinical parameters of CP before treatment were similar so the two groups had the same severity of CP at the baseline. The post-treatment PPD, CAL, PI and BoP values of control & treatment groups have been shown in table 2 and the findings highlighted that the difference in improvement of periodontal health between the treatment and control group was not statistically significant, indicating that periodontal health improved in both trial arms with no difference between groups after two weeks of use of NS oil-based or normal saline-based mouthwashes.

DISCUSSION

The World Health Organization (WHO) has advocated the use of medicinal plants in treatment of any disease condition owing to their promising results and fewer side effects. The organization also encourages developing countries to use medicinal plants as a resource in their health care systems.8
Keeping in view the anti-inflammatory and anti-microbial potential of NS in mind, we investigated the efficacy of NS oil-based mouthwash as an adjunct therapy measure for unhealthy periodontium for two weeks
after initial scaling and root planning. We used normal saline as placebo adjuvant solution in our control group. Interestingly, following scaling and root planning, we found that use of both normal saline mouthwash and NS oil-based mouthwash had statistically significant results regarding improvement in the clinical parameters of CP after two weeks of usage. These results can have two potential implications, one that that both NS oil and normal saline solution have a beneficial effect on improvement of clinical periodontal parameters and two that clinical periodontal parameters improve due to the non-surgical periodontal
therapy and any mouthwash used would have a limited effect.
As for the effectiveness of NS oil-based mouthwash in the present study, other studies support the claim. A study compared the efficacy of mucoadhesive TQ gel mucoadhesive NS extract after scaling and root planning in chronic periodontitis patients. It was found that the use of adjunct treatment to mechanical debridement was more effective in treatment of chronic periodontitis as compared to mechanical treatment by scaling and root planning alone.17
It has also been shown that application of a biodegradable periodontal chip containing TQ for sixty days following conventional scaling and root planning significantly reduced clinical periodontal parameters of CP in patients as compared to the chlorhexidine group. This study advocated the use of TQ-based chips in chronic periodontitis patients as an adjunctive therapy during the scaling and root planning, or for follow-up visits.18 Another study also reported an improvement in clinical parameters of CP after scaling and root planning followed by use of TQ gel in patients with CP as compared to patients undergoing scaling and root planning alone. The results of this study indicated the importance of NS in periodontal treatment even after scaling and root planing.19 Similarly, another study found the use of TQ gel in chronic periodontitis patients significantly led to improvement of parameters of CP as compared to those patients that had only scaling and root planning done. This indicated that use of NS oil also leads to improvement in clinical parameters of CP.20
As regards to normal saline-based mouthwashes, there is mixed data available. Normal saline solution is commonly used as a gargle-based home remedy for conditions such as cough, sore throat and as a mouthwash for oral ulcers.21 An in vitro study advocated the use of short-term rinsing with saline mouthwash solution for improvement of oral health. This study showed the saline solution promoted human
gingival fibroblasts migration and increased the expression of extracellular matrix including collagen-I and cytoskeletal proteins such as F-actin.22 Another study compared the effectiveness of use of normal saline and chlorhexidine for five days in reducing dental plaque in patients with chronic periodontitis. The use of normal saline solution proved to be as effective as chlorhexidine and thus the authors suggested that saline mouthwash rinse can be utilized as an adjunct measure for plaque control and promotion of oral health.21
Our study has also suggested the normal saline solution can be an effective measure for improvement in all clinical parameters of CP after initial scaling and root planning has been performed. The second implication is that both the mouthwashes had a negligible effect on the improvement of clinical periodontal parameters which would have been improved even after simple use of sub-gingival ultrasonic instrumentation (SUI) for scaling and root planning as SUI is in itself reported as an effective measure in removing the periodontal bacteria thus improving healing in the deeper periodontal tissues.23,24 Following SUI, different studies have employed the use of mouthwashes including normal saline, povidone-iodine, chlorhexidine and some essential oils ranging in follow-up from two weeks to six months but all
the studies did not find any difference in the type of mouthwash used for healing and concluded that the use of SUI through sub-gingival plaque removal and bacterial cell disruption achieved by the vibrating chipping action of the scaler tip, cavitational activity, and acoustic micro-streaming alone is effective for controlling and treating periodontal disease.23-25 In our study, we also performed scaling and root
planning and then patients were advised to apply a minimal amount of NS oil or normal saline solution to their gingiva for two weeks. It is possible that we found an improvement in clinical parameters just due to performing of SUI. This also suggested the possibility that the improvement of clinical parameters of CP in our study could be due to the role of scaling and root planning alone without any adjunct therapy
mouthwashes, however, the limitations of the current findings was the use of NS oil mouthwash for only two weeks duration and therefore results cannot be generalized for longer duration studies. Future studies on NS oil may focus on increased sample sizes and longer duration use with follow-up at different time points.

CONCLUSION

It is concluded that the clinical periodontal parameters of PI, CAL, PPD and BoP in the present study improved after two weeks following non-surgical periodontal therapy in both CP groups using NS oil-based mouthwash and normal saline-based mouthwashes. Thus either both mouthwashes had a beneficial effect on clinical parameters or non-surgical periodontal therapy itself was enough for improvement of periodontal health irrespective of the mouthwash used.

ACKNOWLEDGMENTS

We are thankful to all the voluntary study participants that contributed valuable data for this study. We would also like thank to the clinical staff at the periodontology department, Fatima Memorial Hospital, Shadman, Lahore and the staff at Oral Biology department, University of Health Sciences Lahore, regarding their support for the study.

FUNDING DISCLOSURE

The M. Phil studies and financial support of the project for GH was fully funded by the University of Health Sciences, Lahore.

AUTHORS’ CONTRIBUTION

GH did experiments and manuscript writing. SG conceived, designed, did manuscript writing, provided critical revisions through intellectual output and did final approval of the manuscript. SA provided critical revisions through intellectual output and did manuscript writing SC provided critical revisions through intellectual output and did manuscript writing. ZAK provided clinical assistance and gave intellectual output during the sampling procedure CONFLICT OF INTEREST The authors have no conflict of interest

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  21. Aravinth V, Narayanan MA, Kumar SR, Selvamary AL, Sujatha A. Comparative evaluation of salt water rinse with chlorhexidine against oral microbes: A school-based randomized controlled trial. J Indian Soc Pedod Prev Dent. 2017;35:319-26. https://doi.org/10.4103/JISPPD.JISPPD_299_16
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  23. Morozumi T, Kubota T, Abe D, Shimizu T, Nohno K, Yoshie H. Microbiological effect of essential oils in combination with subgingival ultrasonic instrumentation and mouth rinsing in chronic periodontitis patients. Int J Dent. 2013;2013. https://doi.org/10.1155/2013/146479
  24. Lavanchy DL, Bickel M, Baehni P. The effect of plaque control after scaling and root planing on the subgingival microflora in human periodontitis. J Clin Periodontol. 1987;14:295-9. https://doi.org/10.1111/j.1600-051X.1987.tb01536.x
  25. Leonhardt Å, Bergström C, Krok L, Cardaropoli G. Microbiological effect of the use of an ultrasonic device and iodine irrigation in patients with severe chronic periodontal disease: a randomized controlled clinical study. Acta Odontologica Scandinavica. 2007;65:52-9. https://doi.org/10.1080/00016350600973078

1. M.Phil (Trainee-II), Department of Oral Biology, University of Health Sciences, Khayaban-e-Jamia Punjab, Lahore.
2. Assistant Professor, Department of Oral Biology, University of Health Sciences, Khayaban-e-Jamia Punjab, Lahore.
3. Associate Professor, Department of Oral Biology, Institute of Dentistry, CMH Lahore Medical College, Lahore.
4. Assistant Professor, Department of Oral Pathology, University of Health Sciences, Khayaban-e-Jamia Punjab, Lahore.
5. Associate Professor, Department of Periodontology, Fatima Memorial College of Medicine and Dentistry, Shadman, Lahore.
Corresponding author: “Dr. Sarah Ghafoor” < sarahghafoor@uhs.edu.pk >

Non-Surgical Periodontal Therapy Improves Clinical Outcomes in Patients with Chronic Periodontitis Independent of the Use of Nigella Sativa Oil or Normal Saline Mouthwash; Randomized Controlled Trial

Ghazala Hassan                BDS

Sarah Ghafoor                   BDS, PhD, MPHE, BSc

Saira Atif                             BDS, M.Phil, BSc

Saima Chaudhry                BDS, PhD, MME, BSc

Zubair Ahmed Khan          BDS, MCPS

OBJECTIVES: Chronic periodontitis (CP) is an inflammatory disease of microbial origin that harms the health of the oral tissues. The objective of this study was to analyz the effects of Nigella sativa oil mouthwash given for two weeks after non-surgical therapy in patients with CP.
METHODOLOGY: This study was a parallel-arm randomized controlled trial that was conducted after ethical approval and registered with clinicaltrials.gov. The trial followed the guidelines of CONSORT and triple blinding was ensured. A total of fifty voluntary participants, after giving consent and being evaluated for clinical parameters of CP that included Periodontal Pocket Depth (PPD), CAL (Clinical Attachment Loss), PI (Plaque Index) and BoP (Bleeding on Probing) were divided into a control group and a treatment group. Both groups underwent scaling and root planning and were given normal saline solution or Nigella sativa oil respectively to be used as mouthwash daily for two weeks. The clinical parameters were recorded after two weeks and data was analyzed using SPSS (version 25.0).
RESULTS: It was noted that a statistically significant change was found in the pre-treatment and post-treatment values of all CP parameters in both the groups after the use of normal saline and Nigella sativa oil mouthwash. No statistically significant results were obtained when clinical parameters were evaluated between the two groups.
CONCLUSION: The clinical periodontal parameters of PI, CAL, PPD and BoP improved in both study groups two weeks following non-surgical periodontal therapy irrespective of the Nigella Sativa oil-based mouthwash or normal saline-based mouthwash used. It is suggested that either both types of mouthwashes had a beneficial effect or sub-gingival ultrasonic instrumentation itself was enough for improvement of periodontal health irrespective of the mouthwash used.
KEYWORDS: Nigella sativa, Chronic periodontitis, Normal Saline, Oral Health, Dental, Non-surgical Periodontal Therapy
HOW TO CITE: Hassan G, Ghafoor S, Atif S, Chaudhry S, Khan ZA. Non-Surgical periodontal therapy improves clinical outcomes in patients with chronic periodontitis independent of the use of nigella sativa oil or normal saline mouthwash; randomized controlled trial. J Pak Dent Assoc 2021;30(2):81-86.
DOI: https://doi.org/10.25301/JPDA.302.81
Received: 15 December 2020, Accepted: 31 January 2021
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One Point Fixation Versus Two Point Fixation in Zygomaticomaxillary Complex Fractures

Muhammad Husnain Akram          BDS, MFDRCSI

Muhammad Mustafa Ch                 BDS, MDS

Armaghan Israr Mirza                    BDS, FCPS, FFDRCS

Muhammad Usman Akhtar           BDS, MCPS, MDS, BSc

Ammar Saeed                                 BDS, FCPS

OBJECTIVE: To compare the mean satisfaction of patients undergoing one point fixation versus two point fixation for zygomaticomaxillary complex fractures.
METHODOLOGY: This randomized controlled trial was performed at Oral and Maxillofacial surgey department Punjab Dental Hospital. The duration of this study was 6 months (28-8-18 to 28-2-19). After meeting the inclusion criteria 74 patients were enrolled. Informed consent and demographic information was taken. Patients were randomly divided into two groups. One group is treated with one point fixation method and other with two point fixation. Patient were evaluated in terms of satisfaction of score on 3rd day, 14th day and 28th day and were recorded as per operational definitions. All the collected data was entered and analyzed on SPSS version 20.
RESULTS: In this study the mean age of patients in one point group was 42.46±15.325 years while in two points group was 49.32±13.145 years, male to female ratio of the patients was 1.2:1. The mean PSS in one point group was 5.98±0.89 while in two points group was 3.775±0.609 (p-value=<0.001).
CONCLUSION: One point fixation is smarter method and provide significantly better satisfaction than to two point fixation method for ZMC fractures
KEYWORDS: Zygomaticomaxillary Complex Fractures, One Point, Two Point, Satisfaction
HOW TO CITE: Akram MH, Ch MM, Mirza AI, Akhtar MU, Saeed A. One point fixation versus two point fixation in zygomaticomaxillary complex fractures. J Pak Dent Assoc 2021;30(2):74-80.
DOI: https://doi.org/10.25301/JPDA.302.74
Received: 16 September 2020, Accepted: 25 December 2020

INTRODUCTION

The facial skeletal serves a key importance in human body.1
Apart from aesthetics, it gives sense of organ for smell, sight and taste. It also facilitates eating, chewing, breathing and speech .The facial bones share frontal bone, nasal bones, maxillae, zygoma and mandible. And the two maxillae form the middle third of facial skeleton and attached laterally with the two zygomatic bones at zygomaticomaxillary sutures.2
Zygomaticomaxillary complex (ZMC) is the skeletal unit of middle third of face. The boundary of the cheek is defined by zygoma and it separates orbit from maxillary antrum and infratemporal fossa.The zygomatic bone is a quadrangular-shaped bone . It articulates with the four bones at four sutures i.e frontal, temporal, maxillary and sphenoid bones. These sutures are usual weakness areas for fractures.2 The zygomatic bone fractures are the one of the most common mid-facial bone fracture.3
The commonest causes of ZMC fractures are RTAs, falls, violence, work and sports accidents, gunshot wound/blast injuries. Incidence of these fractures is more common among males than females with a 3-5:1 whereas in underdeveloped countries the ratio is as high as 10-40:12. These are most frequent among people who are aged 20-30 years.5
These fractures are diagnosed usually clinically, and confirmed by the radiographs like paranasal sinus (PNS) and occipitomental (OM) views at different angles. In some
cases specialized computerized tomography (C.T scan) is performed as per requirement.1
The treatment of zygomatic bone fracture is either by closed or open reduction. In closed reduction, various approaches like Gillies, Keens, Gerald screw, Champion’s technique and Passwalo hook are used.6
These techniques have advantages and disadvantages on each other .In open reduction, the bone ends are surgically exposed and fracture site is fixed either by osteosynthesis or transosseous wiring after reduction of the fracture site.7 This purpose of this research is the comparison of one versus two point fixation to achieve better outcomes clinically such as patient satisfaction in terms of aesthetics consequently contributing towards the better treatment option for the benefit of patient. In one study conducted in South Korea, the satisfaction score for surgery was 9.4 ± 1.6 in one point fixation group and 7.7 ± 2.6 in two point fixation group.2
Rationale is to find out the better treatment modality as limited number of local studies is available on this topic.
There are more number of trauma cases in Pakistan as large number of population belongs to poor socio-economic status. The mode of transport for a large number of population in Pakistan is mainly motor bikes. Due to lack of awareness, majority of the people do not wear helmets for safety. As the number of trauma cases due to poor socio-economic status of majority of the population in Pakistan is larger, we want to identify a technique with more satisfaction score and more better outcomes so as to provide better treatment modality to patients. The technique which shows better results in future was preferred for public to provide maximum benefits to the patients in terms satisfaction considering the aesthetics.

METHODOLOGY

To compare the mean satisfaction of patients undergoing one versus two point fixation for ZMC fractures was the objective of this study.The study design is Randomized Control Trial. It was conducted in the in the setting of Oral & Maxillofacial Surgery Department Punjab Dental Hospital. The duration was 6 months i.e. from 28-08-18 to 28-02-19.
The sample size of this study is 74(37 in each group) and the technique which is followed is Non- Probability Consecutive Sampling. The inclusion criteria of this study includes i.e All patients presenting with zygomaticomaxillary complex fracture as confirmed with diagnostic imaging involving X-rays i.e. Occiptomental and Submentovertex views respectively and fulfilling other inclusion criterias were recruited in this study.
All cases presented with isolated ZMC fractures in OPD assessed on radiographs as a breach in the continuity of bone, both gender (Male and Female) and Age >18 to < 70 years. Patients with displaced zygomaticomaxillary complex fracture requiring Open Reduction and Internal Fixation (ORIF) based on radiographic and clinical assessment.
The exclusion criteria of this study is i.e comminuted zygomatic bone fracture, gunshot injuries, infected fractures, pathological fractures, Diabetic/Hypertensive patients and the patients who had medical comorbidities. These conditions are confounders, these created bias in study results if included. Medical emergency and any other procedure that may require immediate attention was dealt with first.
All the patients presented in OPD in Oral & Maxillofacial Surgery Dept., with isolated ZMC fratures added according to the criteria of inclusion. All demographic details were collected. Bias and Confounders were controlled by exclusion criteria. All base line investigations were done for oral surgical procedure. Patients divided in groups i.e Group and Group B by lottery method and 37 patients in each.
Group A was with one point fixation i.e. intraoral plate at zygomaticomaxillary buttress. Group B was with two point fixation i.e.one at zygomaticomaxillary and other at frontozygomatic buttress. Reduction of the fracture segments were assessed postoperatively by X-rays i.e. Occiptomental and Submentovertex views. Patient was evaluated in terms of satisfaction of score on 3rd day, 14th day and 28th day and was recorded as per operational definitions. For one point fixation, after giving general anesthesia under aseptic measures and standard surgical drapes, local anesthesia was given intraorally at ZM buttress area. Mucoperiosteal flap was elevated by making the incision of 1 to 2cm at mucobuccal fold which extends to mucosa, submucosa and buccinators muscle fibres if present and fracture site was exposed. Closed Reduction was done initially and bony contour of zygoma was assessed. A five hole plate with 5 mm × 2.5 mm screws on ZM buttress was fixed. Wound will be irrigated and was closed by 3:0 Vicryl suture. For two point fixation, after giving general anesthesia under aseptic measures and standard surgical drapes, in addition to the above mentioned procedure of fixation at ZM buttress and closed reduction, local anesthesia was given extraorally at FZ. A lateral blephroplasty or lateral eyebrow incision was given and flap was elevated to expose the fracture site at FZ. A four hole plate with 4 mm × 2 mm screws on FZ was fixed. Wound was irrigated and closed by proline to minimize scar formation. Patient satisfaction was recorded by descriptive scale from 0 to 10 with 0 as

Pre-Operative Clinical Picture of the patient
Patient was presented with Left ZMC Fracture after RTA

Frontal and Lateral Clinical Views
Intraoperative Clinical Pictures

Fig I: One point fixation-preoperative and postoperative assessment

Pre-Operative Clinical Picture of the patient
Patient was presented with Right ZMC fracture after RTA

 

Intra-Operative Clinical Pictures
Gillie’s Temporal approach fo Closed Reduction of Zygoma

Intra-Operative Clinical Pictures
Lateral Blepharoplasty Skin Incision to expose FZ Suture

Follow-up after 28 days(Extraoral)

Fig II: Two point fixation-preoperative and postoperative assessment

poor patient satisfaction and 10 as very satisfied patient on 3rd day, 14th and 28th post-operative day. The score was calculated in terms of mean of these readings. The zygomatic bone has five main articulations and four processes. Previously published literature supported that at least two or three of these processes should be fixed (Two point versus three point fixation. There is sufficient literature evidence that suggests that adequate stability of fracture segments can be achieved with one point fixation (Ref. Kim ST, Go DH, Jung JH, Cha HE, Woo JH, Kang IG. Comparison of 1-point fixation with 2-point fixation in treating tripod fractures of the zygoma. Journal of Oral and Maxillofacial Surgery 2011;69(11):2848-52). Thus decreasing the surgical morbidity without any compromise. This in turn results in increased patient comfort and satisfaction. Hence we tested this technique with an established method just to assess patient satisfaction while making sure that adequate treatment has been provided.

RESULTS

All the data was entered and analysis was done on on SPSS 20.0. Continuous / Quantitative variables such as age of patient, pain score and patient satisfaction score were described in Mean±Standard Deviation. Categorical / Qualitative variables such as gender, infection at surgical site, were presented in the form of frequency and percentages. Effect modifiers such as age, gender, BMI was controlled through stratification Post stratification, T-test was applied by taking p= < 0.05 as significant. Comparison between these two was shown with the help of T-test. A “p” value of < 0.05 was considered to be significant. The patients in terms of mean age in one point group was 42.46±15.325 years while in two points group was 49.32±13.145 years. There were 21 (56.8%) males and 16 (43.2%) females in one point group while there were 20 (54.1%) males and 17 (45.9%) females in two points group. The gunshot injuries and work related injuries were more common in both groups. Table 1

Table 1: Baseline characteristics of patients

The mean PSS at 3rd day in one point group was 3.59±1.092 while in two points group was 2.78±1.182. This difference was statistically significant i.e. p-value=0.003. At 14th day in one point group was 5.00±1.35 while in two points group was 3.49±1.096. This difference was statistically

Table 2: Comparison of PSS in both groups

significant i.e. p-value<0.001. At 28th day in one point group was 7.00±1.972 while in two points group was 5.05±1.452. This difference was statistically significant i.e. p-value<0.001. The mean PSS in one point group was 5.98±0.89 while in two points group was 3.775±0.609. This difference was statistically significant i.e. p-value <0.001 Table 2.

DISCUSSION

Zygomatic complex fractures are one of the most common fractures of Facial skeleton. The prominence of zygoma give aesthetic look to the face and at the same time makes it vulnerable to get fractured.. About 45% of all midfacial fractures are zygomatic complex fractures. Several approaches are used namely lateral eyebrow, sub cilliary, temporal or intraoral incisions for these type of fractures.8,9 In this research, mean value of mean Patient satisfaction score in one point group was 5.98±0.89 while the mean value of mean Patients satisfaction score in two points group was 3.775±0.609. Statistically one point fixation showed significantly better satisfaction score than to two point fixation i.e. p-value=<0.001. Some of the studies are discussed below showing their results as. According to Seon Tae Kim et al2 , the authors showed that we can avoid unsighty scars with better results and outcome in one point fixation in selected patients .Many studies have demonstrated one point fixation sufficient in terms of stability and outcomes.10-13 Many different approaches and incision have been described and accepted by both patients and surgeons.14
According to Ritesh Vatsa et al, the treatment time in Group I patients was one hour and in Group II patients, two hours showing that one point fixation had shorter operating time. The author showed that one point fixation at zygomatic buttress is a viable option for minimally displaced ZMC fractures for comminuted zygomatic fractures, this one point fixation was not a feasible option. According to Ji Heui Kim et al16, for non-comminuted ZMC fractures, fixaing the zygomaticomaxiilary buttres and avoiding the facial scar is a better option in all aspects.
It was seen that for non-comminuted fractures, the one point fixation at zygomaticomaxillary buttress was stable confirming the studies of Fujioka et al.17 Sufficient alignment and rigidity can be achieved in one point if there is no comminution. On the other hand Davidson et al18 who stated that one point fixation leads to unstability but two point fixation provides better stability than three point fixation.

CONCLUSION

This present study concluded that one point fixation is smarter method and provide significantly better satisfaction than to two point fixation method for ZMC fractures.

CONFLICT OF INTEREST

None to declare

REFERENCES

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  2. Kim ST, Go DH, Jung JH, Cha HE, Woo JH, Kang IG. Comparison of 1-point fixation with 2-point fixation in treating tripod fractures of the zygoma. J Oral and Maxillofac Surg 2011;69:2848-52. https://doi.org/10.1016/j.joms.2011.02.073
  3. Ogata H, Sakamoto Y, Kishi K. A new classification of zygomatic fracture featuring zygomaticofrontal suture: injury mechanism and a guide to treatment. Plastic Surg Int J 2013. https://doi.org/10.5171/2013.383486
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  13. Ellis E, Kittidumkerng W. Analysis of treatment for isolated zygomaticomaxillary complex fractures. J Oral Maxillofac Surg1996;54:386-400. https://doi.org/10.1016/S0278-2391(96)90107-X
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1. FCPS Part-II Resident, Department of Oral and Maxillofacial Surgery, deMontmorency College of Dentistry, Punjab Dental Hospital Lahore.
2. Assistant Professor, Department of Oral and Maxillofacial Surgery Department, deMontmorency College of Dentistry, Punjab Dental Hospital Lahore.
3. Associate Professor, Department of Oral and Maxillofacial Surgery, King Edward Medical University Mayo Hospital Lahore.
4. Professor, Department of Oral and Maxillofacial Surgery, deMontmorency College of Dentistry, Punjab Dental Hospital Lahore.
5. Consultant, Department of Oral and Maxillofacial Surgery, deMontmorency College of Dentistry, Punjab Dental Hospital Lahore.
Corresponding author: “Dr. Muhammad Husnain Akram” < husnainakram@hotmail.com >

One Point Fixation Versus Two Point Fixation in Zygomaticomaxillary Complex Fractures

Muhammad Husnain Akram          BDS, MFDRCSI

Muhammad Mustafa Ch                 BDS, MDS

Armaghan Israr Mirza                    BDS, FCPS, FFDRCS

Muhammad Usman Akhtar           BDS, MCPS, MDS, BSc

Ammar Saeed                                 BDS, FCPS

OBJECTIVE: To compare the mean satisfaction of patients undergoing one point fixation versus two point fixation for zygomaticomaxillary complex fractures.
METHODOLOGY: This randomized controlled trial was performed at Oral and Maxillofacial surgey department Punjab Dental Hospital. The duration of this study was 6 months (28-8-18 to 28-2-19). After meeting the inclusion criteria 74 patients were enrolled. Informed consent and demographic information was taken. Patients were randomly divided into two groups. One group is treated with one point fixation method and other with two point fixation. Patient were evaluated in terms of satisfaction of score on 3rd day, 14th day and 28th day and were recorded as per operational definitions. All the collected data was entered and analyzed on SPSS version 20.
RESULTS: In this study the mean age of patients in one point group was 42.46±15.325 years while in two points group was 49.32±13.145 years, male to female ratio of the patients was 1.2:1. The mean PSS in one point group was 5.98±0.89 while in two points group was 3.775±0.609 (p-value=<0.001).
CONCLUSION: One point fixation is smarter method and provide significantly better satisfaction than to two point fixation method for ZMC fractures
KEYWORDS: Zygomaticomaxillary Complex Fractures, One Point, Two Point, Satisfaction
HOW TO CITE: Akram MH, Ch MM, Mirza AI, Akhtar MU, Saeed A. One point fixation versus two point fixation in zygomaticomaxillary complex fractures. J Pak Dent Assoc 2021;30(2):74-80.
DOI: https://doi.org/10.25301/JPDA.302.74
Received: 16 September 2020, Accepted: 25 December 2020
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