A comparative clinical study to evaluate the efficacy of Ayurvedic Dentifrices in providing dental protection

Phase 2

• Conditions: Health Condition 1: K088- Other specified disorders of teethand supporting structures

• Registration Number: CTRI/2022/09/046004
• Lead Sponsor: Dabur India Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 November 2022

Recruitment & Eligibility

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

Inclusion Criteria

1.Male and female subjects in age group 18 â?? 55 years (both the ages inclusive).

2.Having at least 16 natural, permanent teeth.

3.Subjects with poor dental hygiene (self-reported and clinically diagnosed)

4.Subjects who have plaque and dental caries. (Caries score up to 2 using International Caries Detection and Assessment System (ICDAS).

5.Subjects with extrinsic dental stains (Score up to 2 using Lobene Stain Index)

6.Subjects willing to give their oral swab samples for analysis.

7.Subjects willing to come for follow up visits at the specified time.

8.Subjects ready to follow study related procedures during the study period.

9.Subject able to read, understand and sign an appropriate informed consent form indicating willingness to participate.

Exclusion Criteria

1.A known history or present condition of hypersensitivity to any toothpaste and tooth powder

2.Subjects taking any supplementation known to support teeth health which may interfere study results.

3.The use of antibiotic, analgesic medications, mouthwash or desensitizing toothpaste during the previous 1 month.

4.Any history of periodontal therapy by surgical interventions.

5.Subjects with active periodontal conditions.

6.Subjects who have used any medicated/fluoridated toothpastes.

7.Orthodontic treatment with fixed appliances.

8.Any removable device such as a removable partial denture or orthodontic retainer.

9.The presence of any fixed appliance, large or defective restorations, cracked enamel,

10.Subjects who have a history of smoking or use smokeless tobacco products/betel chewing

11.Subjects who are pregnant or lactating

12.Subjects having severe level of calculus and/ tartar.

13.Any underlying systemic illnesses, medical illness including diabetes mellitus, hypertension, liver disease or history of alcoholism, a positive HIV status, hepatitis etc.

Study & Design

• Study Type: Interventional
• Study Design: Not specified