"Triphala" - A New Herbal Mouthwash in Gingivitis

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

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.

Study Overview

• Status: Completed
• Conditions: Gingivitis
• Intervention / Treatment: Behavioral: Triphala mouthwash; Behavioral: Chlorhexidine mouthwash

Detailed 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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 23 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• systemically healthy subjects of 25-40 years of age with previously untreated gingivitis and minimum 20 teeth,
• gingival index > 1,
• pocket probing depth < 3 mm,
• clinical attachment loss = 0,
• with no evidence of radiographic bone loss

Exclusion Criteria:

• use of systemic antibiotics and anti-inflammatory drugs in the previous 6 months,
• known systemic disease,
• with orthodontic appliances or bridge work that would interfere with evaluation,
• allergy to ingredient used in the study,
• alcoholics,
• who use tobacco in any form,
• mentally retarded subjects,
• pregnant or
• lactating females and
• subjects with poor compliance

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Gingival Index (GI)	The primary outcome variable was the differences for the mean gingival Index (GI) from B/L to 7 days, 30 and 60 days.	differences for the mean GI from B/L to 7 days, 30 and 60 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Plaque Index (PI)	Differences in mean reduction in plaque index (PI) from baseline (B/L) to 7, 30 and 60 days	From Baseline (B/L) to 7 days, 30 and 60 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in oral hygiene index simplified (OHI-S)	differences in mean reduction in Oral hygiene index simplified ( OHI-S)from baseline (B/L) to 7 days, 30 days and 60 days	From baseline (B/L) to 7 days, 30 days and 60 days
Change in microbiological colony counts	in microbiological colony counts from baseline (B/L) to 7 days, 30 days and 60 days	From baseline (B/L) to 7 days, 30 days and 60 days

Collaborators and Investigators

• Sponsor: Government Dental College and Research Institute, Bangalore

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: July 3, 2013
• First Submitted That Met QC Criteria: July 10, 2013
• First Posted (Estimate): July 12, 2013

Study Record Updates

• Last Update Posted (Estimate): July 12, 2013
• Last Update Submitted That Met QC Criteria: July 10, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: Gingivitis; Plaque control; Herbal medicine
• Additional Relevant MeSH Terms: Infections; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Gingivitis; Anti-Infective Agents, Local; Anti-Infective Agents; Disinfectants; Chlorhexidine
• Other Study ID Numbers: GDCRI/ACM/PG/PhD/2/2011-2012