Health Condition 1: K055- Other periodontal diseases
Conditions
Interventions
Intervention1: Patanjali Dantkanti Red Toothpaste (Pan Flavor): Apply approx. 1 gm of toothpaste on the affected area twice a day with a cleaned fingertip and massage gently for a minute followed by 1
Sponsors
Patanjali Ayurved Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects with mild, moderate or severe plaque with plaque index of 2, 3 and 4. 2. Subjects with gingivitis and having extrinsic dental stains. 3. Subjects having T-VSC reading (total volatile sulphur compounds) of =140 ppb (parts per billion). 4. Subjects should be willing to come to the test site without brushing their teeth in the morning of screening visit. 5. Subjects should be willing to not consume anything except water after meal of previous night.
Exclusion criteria
Exclusion criteria: 1. Subjects with plaque index of 0, 1 and 5. 2. Subject with orthodontic bands. 3. Subject with partial removable dentures. 4. Subject having tumor (s) of the soft or hard tissues of the oral cavity. 5. Subject with advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone). 6. Subject with five or more carious lesions requiring immediate restorative treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 Number of carious tooth by dental examinationTimepoint: Comparison of baseline readings i.e. Day 01 (before brushing) with Day 15 (plus 2 days) and Day 30 (plus 2 days).;To assess the effect of the test product on the reduction in plaque by using plaque index and disclosing agentsTimepoint: Comparison of baseline readings i.e. Day 01 (before brushing) with Day 15 (plus 2 days) and Day 30 (plus 2 days).;To assess the effect of the test product on the reduction in T-VSC reading (total volatile sulfur compounds) using a Halimeter:Timepoint: 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. | — |
Countries
India
Contacts
Public ContactDr Parth Joshi
Cliantha Research
Outcome results
None listed