A clinical study to evaluate the effect of a test product (Toothpaste) on subjects with dentinal hypersensitivity.

Not Applicable

• Registration Number: CTRI/2023/12/060912
• Lead Sponsor: Dr. Reddys Laboratories Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1) Males and Non-pregnant (self-declared)/Non-Lactating female subjects of age 18 to 60 years (both inclusive) at the time of consent.

2) Subjects having good general health as determined by the Investigator based on medical history and vital signs.

3) Subjects with localized and generalized dentinal hypersensitivity (preferably with equal number of localized and generalized DH in each group)

4) Subjects with mild to moderate dental hypersensitivity (tested by thermal testing).

5) 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.

6) Subjects with eroded/damaged enamel (Grade 2 – 3 as per Ordinal scale for severity of dental erosion).

7) Subjects who are willing to participate in the study and give a signed consent.

8) Subjects should be willing and able to follow the study protocol to participate in the study.

Exclusion Criteria

1) Pregnant or breastfeeding or planning pregnancy during the study period.

2) Subjects with orthodontic bands.

3) Subjects with partial removable dentures and fixed partial dentures.

4) Subjects 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) Subjects with history of treatment for dentin hypersensitivity

7) Poor periodontal condition

8) Subject who has used antibiotics any time during the one month prior to start of the study.

9) Subjects who consume alcohol.

10) Subjects smoking cigarette or consume any other form of tobacco.

11) Participation in a similar clinical study within the previous 30 Days.

12) Any other condition which could warrant exclusion from the study, as per the investigator’s discretion.

Study & Design

• Study Type: Interventional
• Study Design: Not specified