Health Condition 1: K088- Other specified disorders of teethand supporting structures
Conditions
Interventions
Intervention1: Clogard Sensitive Care Tooth Paste: On Day 1, subjects will be asked on apply the test Product directly on the affected teeth, followed by brushing their teeth with soft bristle toothbr
Sponsors
Hemas Consumer Brands
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age: 18 to 60 years (both inclusive) at the time of consent. 2. Sex: Healthy Male or non-pregnant/non-lactating female. 3. Females of Childbearing potential must have a negative urine pregnancy test performed during screening. 4. Subjects are in good general health as determined by the Investigator based on medical history and vital signs. 5. Subjects with mild to moderate dental hypersensitivity. 6. Subjects complaining of dentinal hypersensitivity following a cold stimulus such as ice cream, iced drink, or a rapid jet of cool air to a particular tooth or teeth. 7. Subjects should be willing to come to the test site without brushing their teeth in the morning of screening visits.
Exclusion criteria
Exclusion criteria: 1. Subject with orthodontic bands. 2. Subject with partial removable dentures. 3. Subjects with history of treatment for dentin hypersensitivity. 4. Subject with Poor periodontal condition. 5. Subjects with Systemic debilitating disease. 6. Subject with Caries or restoration in the area of hypersensitivity. 7. Subjects with orthodontic appliance, crowns, bridges in the area of sensitivity 8. Subjects having tumor (s) of the soft or hard tissues of the oral cavity. 9. Subject with advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dentinal hypersensitivity by thermal test using hot gutta percha and cold spray for its absence, mild, moderate and severe response through responses recorded by dentist.Timepoint: ââ?¬Â¢ baseline (before direct product application), 30 secs (plus 5 seconds), 60 secs (plus 5 seconds), 5 mins (plus 2 mins), 15 mins (plus 2 mins), 30 mins (plus 2 mins), 1 hour (plus or minus 15 mins) and 2 hours (plus or minus 15 mins) after direct product application. ââ?¬Â¢ Day 15 (plus or minus 2 days) and Day 30 (plus or minus 2 days) after brushing the teeth twice daily. | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of self-perceived sensitivity score by subjects using visual analog scale (VAS), from 0 to 10Timepoint: ââ?¬Â¢ baseline (before direct product application), 30 secs (plus 5 seconds), 60 secs (plus 5 seconds), 5 mins (plus 2 mins), 15 mins (plus 2 mins), 30 mins (plus 2 mins), 1 hour (plus or minus 15 mins) and 2 hours (plus or minus 15 mins) after direct product application. ââ?¬Â¢ Day 15 (plus or minus 2 days) and Day 30 (plus or minus 2 days) after brushing the teeth twice daily. ;Subjective evaluation questionnairesTimepoint: Day 15 and Day 30 | — |
Countries
India
Contacts
Public ContactDr Simran Sethi
Cliantha Research
Outcome results
None listed