Health Condition 1: K051- Chronic gingivitis
Conditions
Interventions
None listed
Sponsors
Colgate Palmolive
Eligibility
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gingivitis (Loe and Silness Gingival Index and Ayurveda 3 parameters)Timepoint: Baseline, 3 months and 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Quigley-Hein Plaque IndexTimepoint: Baseline, 3 months and 6 months | — |
Countries
India
Contacts
Public ContactMs Neelima Utgikar
Colgate Palmolive India Ltd
Outcome results
None listed