To evaluate safety, in-use tolerability and efficacy of a toothpaste in healthy subjects.
- Conditions
- Health Condition 1: K055- Other periodontal diseases
- Registration Number
- CTRI/2024/07/071277
- Lead Sponsor
- Patanjali Ayurved Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Subjects with gingivitis and having extrinsic dental stains.
2.Subjects having T-VSC reading (total volatile sulphur compounds) of =140 ppb (parts per billion).
3.Subjects should be willing to come to the test site without brushing their teeth in the morning of screening visit.
4.Subjects should be willing to not consume anything except water after a meal of the previous night.
1.Subject with orthodontic bands.
2.Subject with partial removable dentures.
3.Subject having tumor (s) of the soft or hard tissues of the oral cavity.
4.Subject with advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone).
5.Subject with five or more carious lesions requiring immediate restorative treatment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the effect of the test product on the reduction in T-VSC reading (total volatile sulfur compounds) using a HalimeterTimepoint: Comparison of baseline i.e. Day 01 (before brushing) with 0 hour (+15 mins) after brushing and with 4 hours (+15 mins), 8 hours (+15 mins), and 12 hours (+15 mins) after brushing but before having meals at each time point on Day 01.
- Secondary Outcome Measures
Name Time Method Subjective evaluation questionnaireTimepoint: Comparison of baseline readings i.e. Day 01 (before brushing) with Day 15 (plus 2 days) and Day 30 (plus 2 days).;Subjects’ perception questionnairesTimepoint: 0 mins (plus 5 mins), 30 mins (plus 5 mins) and 60 mins (plus 5 mins)on Day 01 and Day 30 (plus 2 days).;To assess the effect of the test product on Germ Protection by microbial analysis for S. mutansTimepoint: Comparison of baseline (before brushing) with 0 hour (plus 15 mins) after brushing and with 4 hours (plus 15 mins), 8 hours (plus 15 mins), and 12 hours (plus 15 mins) after brushing but before having meals at each time point on Day 01.;To assess the effect of the test product on the reduction in gingivitis using Gingival indexTimepoint: Comparison of baseline readings i.e. Day 01 (before brushing) with Day 15 (plus 2 days) and Day 30 (plus 2 days).