Clinical study of herbal toothpaste to check the efficacy against gum problems

Phase 3

• Conditions: Health Condition 1: K051- Chronic gingivitis

• Registration Number: CTRI/2021/12/038624
• Lead Sponsor: Colgate Palmolive

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

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

Recruitment & Eligibility

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

Inclusion Criteria

Potential subjects must meet ALL of the following criteria:

Males and females, between 25-70 years of age;

Informed Consent Form signed and availability for the duration of the study;

Good general health (absence of any condition that, in the opinion of the Principal Investigator, might constitute a risk to the subject while participating in the study. Examples include heart problems, valve/hip replacements, etc);

Willingness to provide information related to their medical history and a negative Covid-19 test via RT PCR or a Rapid Antigen test within 48 hours prior to site visits;

Minimum of 10 uncrowned permanent natural teeth (excluding third molars);

Initial mean gingivitis index of at least 1.5 as determined by the use of the Loe and Silness Gingival Index and at least 10% of bleeding sites;

Availability for the duration of the study.

Exclusion Criteria

Potential subjects must NOT HAVE ANY of the following conditions:

Oral pathology, chronic disease, or a history of allergy to testing products;

Subject using anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, anti-inflammatory medication or daily analgesics within one month prior to the start of the study or scheduled to start such intake during the course of the study;

Subject participating in any other clinical study that might interfere with the main study outcome;

Subject pregnant or breastfeeding;

Subject allergic to oral care products, personal care consumer products, or their ingredients;

Extended use of antibiotics or therapeutic mouthwash any time during the three months prior to entry into the study;

Ongoing use of medications known to affect the gingival tissues (i.e. calcium channel blockers, phenytoin, cyclosporine);

Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone). Pocket depth greater than 4 mm, periodontal abscess(es), teeth with mobility > 1;

Current smokers, tobacco users and subjects with a history of alcohol or drug abuse;

An existing medical condition which prohibits eating or drinking for periods up to 4 hours.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gingivitis (Loe and Silness Gingival Index and Ayurveda 3 parameters)Timepoint: Baseline, 3 months and 6 months

Secondary Outcome Measures

Name	Time	Method
Quigley-Hein Plaque IndexTimepoint: Baseline, 3 months and 6 months