To study efficacy of Herbal Toothpaste in improving oral hygiene and bad breath
- Conditions
- Chronic gingivitis,
- Registration Number
- CTRI/2018/03/012817
- Lead Sponsor
- Dabur India Limited
- Brief Summary
The study was monocentric, single arm efficacy study. The study was conducted for a period of 6 weeks for each subject 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. A total of 40 male and female subjects were enrolled in the study. All the subjects completed the study and no drop outs were reported. There was no side effects/ adverse event during the period of the study. The oral hygiene parameters were assessed in terms of Gingival Index, Plaque index, Gingival Bleeding Index and Oral malodor (bad breath).
Results: The test product was found to significantly reduce plaque, gingivitis and gingival bleeding scores at the end of 6 weeks of study period. The test product was found to significantly reduce bad breath, 12 hours after brushing teeth after twice daily brushing for a period of 6 weeks. Majority of the subjects (80%) reported to experience fresh breath that lasts from few hours to day long. Maximum subjects (97.5%) reported to experience deep mouth clean along with fresh breath.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 40
- All participants had at least 20 natural teeth with no probing depths greater than 3 mm and a plaque index score of 1.50 or more at baseline.
- All participants had a bad breath score of 2.0 or more at baseline.
- All participants had a Gingival Bleeding Index score of 3.0 or more at baseline.
- Subjects having history of known sensitivity or oral mucosal tissue reaction to test toothpaste.
- Subjects undergoing antibiotic or antiinflammatory therapy or had undergone such therapy in the past 6 months.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Ayurvedic Medicated Toothpaste reduces plaque, gingivitis, gingival bleeding and bad breath Baseline, 3 weeks, 6 weeks
- Secondary Outcome Measures
Name Time Method Overall freshness and safety of the subjects throughout the study period Baseline, 6 weeks
Trial Locations
- Locations (1)
Inderprastha Dental College & Hospital
🇮🇳Ghaziabad, UTTAR PRADESH, India
Inderprastha Dental College & Hospital🇮🇳Ghaziabad, UTTAR PRADESH, IndiaDr Sonia DattaPrincipal investigator01204176700pankajdatta97@gmail.com