To study the efficacy of two herbal toothpastes in oral hygiene

Phase 2/3

Completed

• Conditions: Chronic gingivitis,

• Registration Number: CTRI/2018/04/013171
• Lead Sponsor: Dabur India Limited

Brief Summary

The study was randomized, parallel group, monocentric, comparative, standard control, double blind, efficacy study. The duration of product application was conducted for a period of 6 weeks on 80 subjects aged between 20-60 years (both inclusive) and included a total of 3 visits (Baseline, 3 weeks, 6 weeks). The subjects who satisfy inclusion/exclusion criteria were enrolled after obtaining informed consent.  All the subjects completed the study with no signs of adverse event/side effects during the study period. Both the toothpastes were found to be significantly reducing plaque, gingivitis and gingival bleeding scores at the end of 6 weeks study period twice daily brushing. The difference in decrease in plaque, gingivitis and gingival bleeding sites was statistically non significant between the two test toothpastes after twice-daily brushing for a period of 6 weeks.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-13
• Study Completion: 2016-09-10
• Last Update Posted: 2019-11-02

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• All subjects having at least 20 natural teeth with no probing depths greater than 3 mm and a plaque index score of 2 or more at baseline.
• Subjects with plaque index score greater than equal to 1.5 according to the Quigley-hein PI scoring procedure and a gingival index score of freater than equal to 1.0 3.
• Subjects having adequate oral hygiene with no signs of oral neglect, good periodontal health and no greater than 5 periodontal pockets of 5 mm.

Exclusion Criteria

• Subjects having history of known sensitivity or oral mucosal tissue reaction to toothpaste.
• Subjects undergoing antibiotic or anti-inflammatory therapy or undergone such therapy in the past 6 months.
• Subjects participating in any other study or who had participated in a study within one month prior to enrollment 4.
• Pregnant or lactating women 5.
• Subjects presented with orthodontic bands; or partial or removable dentures; or received dental prophylaxis anytime during 2 week prior to the first dental examination 6.
• Subjects having a history of tobacco, alcohol or drug abuse.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction of Plaque, Gingivitis and Gingival Bleeding	Baseline, 3 weeks, 6 weeks

Secondary Outcome Measures

Name	Time	Method
Overall safety of the subjects throughout the study period	Baseline, 3 weeks, 6 weeks

Trial Locations

Locations (1)

Inderprastha Dental College & Hospital; 🇮🇳 Ghaziabad, UTTAR PRADESH, India

Inderprastha Dental College & Hospital

🇮🇳Ghaziabad, UTTAR PRADESH, India

Dr Sonia Datta

Principal investigator

01204176700

pankajdatta97@gmail.com