|Year : 2020 | Volume
| Issue : 1 | Page : 32-36
Comparison of effectiveness for Stevia rebaudiana and chlorhexidine mouthrinses on plaque and gingival scores among 12–15-year-old government school children in Belagavi City – A randomized controlled trail
Barkha Shivkumar Tiwari1, Anil V Ankola1, Roopali M Sankeshwari1, Pratibha Patil1, Bhargava R Kashyap1, Uday B Bolmal2
1 Department of Public Health Dentistry, KAHER, Belagavi, Karnataka, India
2 Department of Pharmaceutics, KAHER, Belagavi, Karnataka, India
|Date of Submission||04-Oct-2018|
|Date of Acceptance||17-Dec-2019|
|Date of Web Publication||23-Jan-2020|
Dr. Barkha Shivkumar Tiwari
Department of Public Health Dentistry, KAHER, Belagavi, Karnataka
Source of Support: None, Conflict of Interest: None
AIM OF THE STUDY: The present study was undertaken to compare the effectiveness for two mouthrinses Stevia and chlorhexidine (CHX) on plaque and gingival scores among 12–15-year-old government school children in Belagavi city.
MATERIALS AND METHODS: This was a triple-blind randomized controlled field trial which was crossover in design. The study included 70 children aged 12–15 years from two randomly selected government schools in Belagavi city. The study was divided into two phases: each phase lasted for 7 days separated by a washout period of 21 days in between them. Each group was subjected to both the interventions in a phased manner. The study participants were instructed to use 10 ml of the assigned mouthwash twice daily for 30 s for 7 days. At the baseline, examination parameters such as plaque and gingival scores were recorded. Reevaluation of both the parameters was done after 7 days at both the phases of the study. Data obtained was compiled, tabulated, and subjected to statistical analysis using the Wilcoxon signed-rank test.
RESULTS: Statistically significant reductions (P<0.001) in plaque and gingival scores were found for both the mouthrinse group at both the phases of the study from the baseline to the 8th day (immediately after discontinuing the mouthwash).
CONCLUSION: Among the two mouthwashes, CHX had superior effectiveness in reducing plaque scores and gingival scores. Stevia mouthwash exhibited almost similar anti-plaque and antigingivitis effect and can be used as an adjunct to the regular oral hygiene practices and can also be potentially included in various oral hygiene products.
Keywords: Children, chlorhexidine, gingivitis, mouthrinse, plaque, Stevia rebaudiana
|How to cite this article:|
Tiwari BS, Ankola AV, Sankeshwari RM, Patil P, Kashyap BR, Bolmal UB. Comparison of effectiveness for Stevia rebaudiana and chlorhexidine mouthrinses on plaque and gingival scores among 12–15-year-old government school children in Belagavi City – A randomized controlled trail. Indian J Health Sci Biomed Res 2020;13:32-6
|How to cite this URL:|
Tiwari BS, Ankola AV, Sankeshwari RM, Patil P, Kashyap BR, Bolmal UB. Comparison of effectiveness for Stevia rebaudiana and chlorhexidine mouthrinses on plaque and gingival scores among 12–15-year-old government school children in Belagavi City – A randomized controlled trail. Indian J Health Sci Biomed Res [serial online] 2020 [cited 2020 Feb 28];13:32-6. Available from: http://www.ijournalhs.org/text.asp?2020/13/1/32/276422
| Introduction|| |
Dental plaque is a very dense, structured bacterial aggregation in a complex matrix comprised in part of extracellular polysaccharides. Approximately 75% of plaque volume is composed of bacterial cells. The other 25% consist of epithelial cells, leukocytes, and macrophages in an intermicrobial matrix.
Self-performed mechanical plaque removal is an unquestioned method of controlling plaque and gingivitis. However, toothbrushing and flossing are difficult tasks, and most of the patients are not able to completely remove plaque from all tooth surfaces. Mechanical plaque control is also time consuming, and some individuals may lack motivation for such procedures.
Chemical anti-plaque agents present in mouthrinses are considered less technically demanding adjuvant to mechanical control. Among the available mouthrinses, Chlorhexidine (CHX) has been considered as the “Gold Standard” and is highly effective in reducing the oral microbial load.
However, the use of CHX is burdened by some side effects, such as stains, brown pigmentations on the dental surfaces, prosthetic and composite restorations, alterations in taste, parotid swelling, and erythematous – desquamative lesions of the oral mucosa.
Hence, an effective alternative to CHX which is locally available, culturally acceptable, and affordable, is highly desirable.
The current research is focused on the elaboration of a new methodology that is based on the identification of natural active compounds that have anti-plaque activity.
One such shrub that has medicinal value is Stevia rebaudiana which is a perennial shrub of the Asteraceae family, native of Paraguay and Brazil, which is most often used to sweeten local teas and medicines.
Stevioside and rebaudioside A are the most represented glycosides in S. rebaudiana leaves. Stevioside tastes between 200 and 300 times sweeter than sugar. Stevia in addition to being a noncaloric sweetener has shown many health benefits when used as a dietary supplement which includes antihyperglycemic, antihypertensive, anti-inflammatory, antitumor, antidiarrheal, diuretic, and immunomodulatory actions. Another advantage is that no toxic or genotoxic activity has been found in the complete extracts obtained from S. rebaudiana leaves.
Furthermore, a caries-preventive action of Stevia extracts was proposed related to the antibacterial properties and a reduction in the intake of fermentable carbohydrates. Stevia sweeteners have also shown to be noncariogenic.
Hence, the present study was conducted to find the effectiveness of Stevia mouthrinse on plaque and gingival scores in comparison with CHX mouthrinse so that its practical application can be given in future.
| Materials and Methods|| |
S. rebaudiana leaves and its powder were purchased by a company Stevia Zone, Ahmedabad, Gujarat, India. Authentication of the same was done at KLE's B.M Kankanwadi Ayurveda College, Shahpur, Belagavi, Karnataka, India.
According to the literature review, the minimum inhibitory concentration of aqueous suspension of Stevia mouthrinse was obtained at 0.5%. Therefore, considering this value, Stevia mouthrinse was prepared.
The present study was a triple-blind randomized controlled trial with crossover in design carried out in two randomly selected government school, Belagavi. The ethical clearance was obtained from the Institutional Ethical Review Board and permission was obtained from the Deputy Director of Public Instructions. Children and their parents were explained in detail about the study, for publication of data for researchfor participation in the study.
Children aged 12–15 years who were free from systemic diseases and with moderate gingival scores and fair plaque scores according to plaque and gingival indices proposed by Silness and Loe (1964) and Loe and Silness (1963), respectively, were included in the study. Medically compromised children, children using any other chemical mode of plaque control, and children under medications that could affect the state of the gingival tissues were not included in the study.
A total of 81 children from School 1 and 103 children from School 2 aged 12–15 years underwent the screening procedure; 57 children from School 1 and 63 from School 2 fulfilled the study inclusion and exclusion criteria. Of these, 35 children in each group were selected randomly from both the schools using a table of random numbers, comprising a total sample size of 70 [Figure 1]. The study was divided into two phases – Phase 1 and Phase 2, each phase for a period of 7 days. In Phase 1, Group A and Group B participants were asked to rinse with 10 ml Stevia mouthrinse and CHX mouthrinse, respectively, for 30 s. After a washout period of 21 days, in Phase 2, the mouthrinses were reversed for both the groups. In this way, each participant received both the mouthrinses sequentially.
Training and calibration of the examiner was done to record indices (plaque and gingival indices) used in the study, in the Department of Public Health Dentistry under the guidance of a subject expert to limit the intra-examiner variability. The recording assistant was trained in documenting the readings accurately. The intra-examiner variability was calculated using kappa statistics (0.9).
A periodic assessment form was prepared for the evaluation of plaque and gingival index of participants at the baseline and after 7 days (8th day) and reevaluation after a washout period of 21 days.
The schools were visited on the scheduled dates and the plaque and gingival scores for all the selected children (n = 70) were recorded by the principal investigator under natural lighting conditions. Baseline gingival and plaque indices were recorded. After the baseline evaluation, oral hygiene instructions were given by the investigator with the aim of standardizing oral hygiene maneuvers during the study period. A recording clerk who was trained to assist in the recording procedure helped the examiner in recording the findings.
Prepared Stevia mouthrinse (0.5%) and commercially available CHX mouthwashes (0.2%) were administered to children twice daily, i.e., morning at 10:30 am and at night after dinner for 7 days. One day prior to the day of visit to the school, the pharmacist was asked to dispense the mouthrinses in two amber-colored bottles and label it as A and B, respectively. The contents of the bottles were disclosed (blinded) to the principal investigator. Reevaluation of all the study parameters was done after 7 days (8th day) in both the groups at both the phases of the study.
Data were entered into Microsoft Excel and were analyzed using SPSS for Windows, Version 21 (SPSS, Inc., Chicago, IL, USA). Descriptive statistics were used to calculate frequencies, percentages, and mean values. Wilcoxon signed-rank test was used for the paired analysis of data in a crossover study.
At the onset of the study, there were 70 study subjects. There were no drop outs from any group. Mean age of the participants in Group A was 13.06(±0.8) and in Group B was 13.03(±0.8). There was more number of male participants (57.1%) in both the groups. Most of the participants belonged to upper lower class (74.3%). More than (80%) of the participants used toothbrush as an oral hygiene aid and fluoridated toothpaste as a plaque controlling agent. Almost (85%) cleaned their teeth once daily in the morning.
Both Group A and Group B showed statistically significant reduction in the mean plaque and gingival scores from baseline to post-test at both the phases of the trail [Table 1] and [Table 2]. The mean reduction of plaque and gingival scores among all the participants after the intervention for Chlorhexidine and Stevia mouthwash was also found to be statistically significant (p<0.05) [Table 3] and [Table 4].
|Table 1: Comparison of mean±standard deviation plaque score at the baseline and post-test in Group A and Group B at different phases of trial|
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|Table 2: Comparison of mean±standard deviation gingival score at the baseline and post-test in Group A and Group B at different phases of trial|
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|Table 3: Comparison of reduction in mean (± S.D.) plaque scores following the intervention of Chlorhexidine (CHX) and Stevia mouthwashes among all the participants of cross-over study|
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|Table 4: Comparison of reduction in mean (±S.D.) gingival scores following the intervention of Chlorhexidine and Stevia mouthwashes among all the participants of cross-over study|
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Maximum acceptability for taste (68.6%) and mouth cleanliness (77.1%) was seen for Chlorhexidine mouthwash when compared with Stevia mouthwash. The acceptability for smell and color was equal for both Stevia and Chlorhexidine mouthwash.
The study was registered under Clinical Trial Registry No. - CTRI/2018/04/013046 with Trial REF/2018/03/018046 and it was conducted according to the principles outlined in the Declaration of Helsinki on experimentation involving human subjects.
| Discussion|| |
Oral health is a reflection of one's systemic wellness and quality of life. According to WHO, it is a state of being free of orofacial pain, malignancy, infections, periodontal disease, tooth decay, tooth loss, and other diseases and disorders that limit an individual's functional capacity and psychosocial well-being.
Dental plaque is a multifaceted biofilm community where bacterial populations exist as separated microcolonies in physiologically diverse environments. These microorganisms comprise a decisive etiological factor in the origin and development of caries and inflammatory periodontal disease. It has been reported that mechanical tooth cleaning alone is not sufficient to achieve plaque control; hence, chemical methods should be used to supplement mechanical tooth cleaning.,
Natural therapies offer a substantially wide range of biological properties which will help as a powerful tool in control and eradication of dental diseases in future. The present study used 0.5% Stevia mouthrinse in a suspension form to retain the active components present in the leaves.
Stevia mouthwash showed a significant reduction in plaque and gingival scores from the baseline to after discontinuation of the mouthwash (8th day). This result was in accordance with the study done by De Slavutzky which showed a reduction in plaque scores using a 10% solution of aqueous S. rebaudiana extract for 5 days. Similar results were also found in a study done by Vandana et al. using 10% Stevia mouthwash showing a reduction in mean plaque scores at 3 months and 6 months as compared from the baseline. The anti-plaque effect of Stevia can be attributed to the presence of tannins and xanthines (theobromine and caffeine), and antigingivitis effect can be attributed to the presence of flavonoids which possess anti-inflammatory activity.
CHX mouthwash showed better significant reductions in the mean plaque and gingival scores from the baseline to after discontinuation of the mouthwash (8th day). This result was in accordance with the study done by Lee et al., Sharma et al., and Singhal et al.,, This effect could be explained because it is a di-cationic broad-spectrum antimicrobial agent, which primarily acts by preventing pellicle formation, and is involved in destabilization of the outer bacterial membrane, thereby preventing bacterial cell wall adsorption and binding of mature plaque. Its antibacterial action against the pathogenic bacteria which causes gingival disease is due to an increase in cellular membrane permeability followed by the coagulation of the cytoplasmic macromolecules.
| Conclusion|| |
Twice daily rinsing with Stevia (0.5%) and CHX (0.2%) mouthrinse for 7 days caused significant reductions in plaque scores and gingival scores on the 8th day from the baseline. Stevia mouthrinse had similar antimicrobial effect on plaque scores and gingival scores when compared with the positive control (0.2% CHX). However, CHX performed comparatively better than Stevia.
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Conflicts of interest
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[Table 1], [Table 2], [Table 3], [Table 4]