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To study the efficacy of two herbal toothpastes in oral hygiene

Phase 2
Completed
Conditions
Health Condition 1: K051- Chronic gingivitis
Registration Number
CTRI/2018/04/013171
Lead Sponsor
Dabur India Limited
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
80
Inclusion Criteria

1. All subjects having at least 20 natural teeth with no probing depths greater than 3 mm and a plaque index score of 2 or more at baseline.

2. Subjects with plaque index score greater than equal to 1.5 according to the Quigley-hein PI scoring procedure and a gingival index score of freater than equal to 1.0

3. Subjects having adequate oral hygiene with no signs of oral neglect, good periodontal health and no greater than 5 periodontal pockets of 5 mm

Exclusion Criteria

1. Subjects having history of known sensitivity or oral mucosal tissue reaction to toothpaste.

2. Subjects undergoing antibiotic or anti-inflammatory therapy or undergone such therapy in the past 6 months.

3. Subjects participating in any other study or who had participated in a study within one month prior to enrollment

4. Pregnant or lactating women

5. Subjects presented with orthodontic bands; or partial or removable dentures; or received dental prophylaxis anytime during 2 week prior to the first dental examination

6. Subjects having a history of tobacco, alcohol or drug abuse

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Reduction of Plaque, Gingivitis and Gingival BleedingTimepoint: Baseline, 3 weeks, 6 weeks
Secondary Outcome Measures
NameTimeMethod
Overall safety of the subjects throughout the study periodTimepoint: Baseline, 3 weeks, 6 weeks
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