A clinical study to test the effect of 2 product formulations against a control, on gingival conditions and plaque levels, in an experimental gingivitis model after 3 weeks of home use.

Phase 3

Completed

• Registration Number: CTRI/2009/091/000626
• Lead Sponsor: Smile Care Clinic Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

1. Ability to understand and sign a consent form prior to the recruitment on the study.
2. Male and female subjects 18 -45 years
3. Patients with moderate gingivitis MGI average ≥2 but showing no signs of periodontitis (absence of periodontal pockets )
4. Minimum 24 scorable, non restored natural teeth.
5. Good general and oral health
6. Ability and willingness of subjects to follow the study procedures(refraining from all oral hygiene method except study product use for 3 weeks,) attend all scheduled visits and successfully complete the study

Exclusion Criteria

1. Periodontitis, active unfilled caries , heavy stains
2. Compulsive paan or tobacco consumers
3. Orthodontic bands, dentures
4. Allergy to any dental or oral hygiene products
5. Medical conditions that would affect oral health eg. Diabetes,
6. Females who are pregnant or nursing or use contraceptive pills.
7. Recent use of anti-inflammatory or antibiotic medicaments.
8. Participating in any other study.

Study & Design

• Study Type: Observational
• Study Design: Not specified