Evaluation of Triphala and chlorhexidine mouthwash use in reducing tooth decay and gum problems

Phase 2

Completed

• Conditions: ICD 10 - K05.1Chronic gingivitis

• Registration Number: CTRI/2017/10/010155
• Lead Sponsor: Dr Ketaki Bhor

Brief Summary

This study is a randomized controlled double blind parallel three month clinical trial conducted among 72 school children of age group of 14-15 years, who are divided into two study groups: Group A- Triphala mouthwash (n=36) and Group B- Chlorhexidine mouthwash (n=36). The microbial counts were measured by conventional culture methods and plaque scores and gingival scores were recorded by using Plaque Index [Loe H (1967)] and Gingival Index [Loe H and Silness J (1963)] respectively at baseline, 30 days and 90 days interval. The primary outcome is to assess and compare the effect of 0.4% Triphala and 0.12% Chlorhexidine mouthwash on dental plaque, gingival inflammation and microbial count of *Streptococcus mutans, Streptococcus sanguinis and Lactobacilli* from dental plaque sample of 14-15 years old school children during 90 days supervised use.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-21
• Study Completion: 2017-11-30
• Last Update Posted: 2019-11-19

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• 1.Study participants of age group 14-15 years 2.Study participants with similar i.socioeconomic status [Based on Kuppuswammy’s Socioeconomic status scale], ii.oral hygiene methods 3.At least 20 intact natural teeth should be present.
• 4.Study participants with fair plaque score (Loe H 1967) and moderate gingivitis (Loe H and Silness J 1963) were selected.
• 5.Study participants willing to participate in the study and whose parents gave a written informed consent.

Exclusion Criteria

• 1.History of hypersensitivity to any product used in the study and other oral care products.
• 2.Unable to comply with the study appointment schedules.
• 3.Any oral soft tissue pathology.
• 4.Grossly decayed teeth and over-retained deciduous teeth.
• 5.Study participants having calculus 6.Suffering from non-plaque induced gingivitis or periodontitis.
• 7.Study participants with any systemic disorders that require the use of medications with side effects known to affect oral health.
• 8.Study participants using mouth rinse within the last 3 months.
• 9.Study participants under antimicrobial therapy at least 3 month prior to the study and using mouth rinses or dentifrices containing substances with anti-inflammatory properties.
• 10.Study participants with crowns or restorations on facial and lingual surfaces of teeth.
• 11.Study participants with malocclusion or fixed/ removable orthodontic appliances.
• 12.Study participants who are physically or mentally handicap.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.To assess the effect of Triphala and Chlorhexidine mouthwash on dental plaque score and gingivitis score and microbial count of Streptococcus mutans, Streptococcus sanguinis and Lactobacilli from the dental plaque samples.	The demonstration regarding th use of mouthwash and the collection of plaque sample was done at 0 day, 30th day and at 90th day
3.To compare the effect of Triphala and Chlorhexidine mouthwash on dental plaque, gingival inflammation and microbial count of Streptococcus mutans, Streptococcus sanguinis and Lactobacilli from the dental plaque samples	The demonstration regarding th use of mouthwash and the collection of plaque sample was done at 0 day, 30th day and at 90th day

Trial Locations

Locations (4)

Dyandeep english medium school; 🇮🇳 Pune, MAHARASHTRA, India

jai hind english medium school; 🇮🇳 Pune, MAHARASHTRA, India

royal roses english medium school; 🇮🇳 Pune, MAHARASHTRA, India

utkarsha english medium school; 🇮🇳 Pune, MAHARASHTRA, India

Dyandeep english medium school

🇮🇳Pune, MAHARASHTRA, India

dr ketaki bhor

Principal investigator

8007786257

ketaki.bhor@gmail.com