CTRI/2021/12/038624
Not yet recruiting
Phase 3
â??Clinical research study is to evaluate the efficacy of aâ?? toothpaste containing herbal ingredients on established â??dental â??plaque and gingivitis in adults
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: K051- Chronic gingivitis
- Sponsor
- Colgate Palmolive
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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;
Outcomes
Primary Outcomes
Not specified
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