"Triphala" - A New Herbal Mouthwash in Gingivitis

Gingivitis Clinical Trial

Official title: "Triphala" - A New Herbal Mouthwash in Gingivitis: A Randomized Controlled Clinical Trial

Status Completed

Clinical Trial Summary

The present study was a randomized control clinical trial, which included 90 subjects with chronic generalised gingivitis of age group 25-40 years, reporting to outpatient department of Periodontics, Government Dental College & Research Institute, Bangalore form January 2013 to April 2013. The research protocol was initially submitted and approved by the Institutional Ethical Committee and Review Board of the Government Dental College and Research Institute, Bangalore. After ethical approval, all subjects were verbally informed and written signed informed consent was taken for participation in the study.

Ninety subjects diagnosed with chronic generalized gingivitis were randomly assigned into three groups: Group I: Placebo mouthwash, Group II: Triphala (TRP) mouthwash, Group III: Chlorhexidine (CHX) mouthwash. Subjects were instructed to use mouth wash twice daily. The plaque index (PI), gingival index (GI) and oral hygiene index- simplified (OHI-S) and microbiological colony counts were recorded on baseline (B/L) and 7, 30 and 60 days respectively.

TRP mouthwash was found to decrease the inflammatory parameters. As improvement in gingivitis was comparable to that of CHX mouthwash thus TRP mouthwash can be considered as a potential therapeutic agent in treatment of gingivitis.

Clinical Trial Description

Objective: The aim of the present study is to evaluate the efficacy of triphala (TRP) as a mouthwash in reduction of plaque and gingivitis.

Material & Methods: Ninety subjects diagnosed with chronic generalized gingivitis were randomly assigned into three groups: Group I: Placebo mouthwash, Group II: TRP mouthwash, Group III: Chlorhexidine (CHX) mouthwash. Subjects were instructed to use mouth wash twice daily. The plaque index (PI), gingival index (GI) and oral hygiene index- simplified (OHI-S) and microbiological colony counts were recorded on baseline (B/L) and 7, 30 and 60 days respectively.

Results: There was a gradual decrease in the PI, GI and OHI-S scores by the 7 days, 30 days and 60 days time interval, respectively, in all three groups. Microbial counts also showed significant reduction in all the groups at all the time intervals except in Group 1. There was a significant difference with respect to reduction in PI, GI, OHI-S and microbiological counts in Group I as compared to Group II and Group III. However, no significant difference was found between Group II and Group III for all the parameters at all-time intervals.

Conclusion: TRP mouthwash was found to decrease the inflammatory parameters. As improvement in gingivitis was comparable to that of CHX mouthwash thus TRP mouthwash can be considered as a potential therapeutic agent in treatment of gingivitis. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gingivitis

• NCT number: NCT01898000
• Study type: Interventional
• Source: Government Dental College and Research Institute, Bangalore
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Completion date: April 2013