Clinical trial NCT01898000: "Triphala" - A New Herbal Mouthwash in Gingivitis
Official title: "Triphala" - A New Herbal Mouthwash in Gingivitis: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingivitis
Keywords: Gingivitis
Herbal medicine
Plaque control
Lead sponsor: Government Dental College and Research Institute, Bangalore
Sponsor class: OTHER
First posted: 2013-07-12
Enrollment: 90
Sex: ALL
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Gingival Index (GI)
timeFrame: differences for the mean GI from B/L to 7 days, 30 and 60 days
Secondary outcomes:
measure: Change in Plaque Index (PI)
timeFrame: From Baseline (B/L) to 7 days, 30 and 60 days
Other outcomes:
measure: Change in oral hygiene index simplified (OHI-S)
timeFrame: From baseline (B/L) to 7 days, 30 days and 60 days
measure: Change in microbiological colony counts
timeFrame: From baseline (B/L) to 7 days, 30 days and 60 days
Locations:
Study officials:
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