Evaluation of Efficacy And Safety of Sensitive Tooth Paste.

Not Applicable

Completed

• Conditions: Health Condition 1: K05- Gingivitis and periodontal diseases

• Registration Number: CTRI/2022/03/041320
• Lead Sponsor: Patanjali Ayurved Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-05-23
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 35

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 no dental condition (Normal Group).

6.Subjects with mild, moderate and severe dental hypersensitivity (1:1:1).

7.Subjects with mild, moderate or severe plaque with plaque index of 2, 3 and 4.

8.Subjects with gingivitis and having extrinsic dental stains.

9.Subjects having T-VSC reading (total volatile sulphur compounds) of �140 ppb (parts per billion).

10.Subjects should be willing to come to the test site without brushing their teeth in the morning of screening visits.

11.Subjects should be willing to not consume anything except water after meal of previous night.

12.Subject must be able to understand and provide written informed consent to participate in the study.

13.Subjects willing and able to follow the study protocol and study directions, to participate in the study.

Exclusion Criteria

1.Subject with orthodontic bands.

2.Subjects with plaque index of 0, 1 and 5.

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.

7.Subject having used antibiotic any time during the one month prior to entry into the study.

8.Subject having participation in any other dental clinical study within last six months prior to entry into the study.

9.Subjects with dental prophylaxis during the last two weeks prior to baseline examinations.

10. Subject with history of allergies to oral care/personal care consumer products or their ingredients.

11.Subjects on any prescription medicines that might interfere with the study outcome.

12.Subjects taking oral contraceptives and other medication-based contraceptives.

13.Female subjects who are pregnant or who are on lactation.

14.Consumption of any medicated sweets, chewing gum, breath fresheners, etc. containing anti-microbial agents.

15.Subjects with diseases or having history that potentially can contribute to oral malodor (e.g., diabetes mellitus, bronchitis, tonsillitis, sinusitis etc.)

16.Subjects who consume alcohol.

17.Subject smoking cigarette or consume any other form of tobacco.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dentinal hypersensitivity by thermal test using hot gutta percha and cold spray for its absence, mild, moderate and severe response through responses recorded by dentistTimepoint: Baseline (Before Brushing), 0 hour (30and 60 seconds with window period of plus 5 seconds after brushing)