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Rinse contains an anti-plaque agent that helps prevent the accumulation of dental plaque associated with gingivitis.
Full description
This is a prospective, single site, randomized, parallel, blinded clinical trial. Subjects will be randomly assigned to one of four treatment groups identified as Product A, Product B, Product C or Product D.
Subjects will be screened for eligibility and entered into a washout period that is at least 7 days, during which time they will be provided with study toothbrush, toothpaste and dental floss. No oral rinses or medication that alters oral tissue health will be used or taken during the washout period. After randomization, the designated rinse will be placed into a non-transparent container so that other subjects and clinical examiners do not see the allocated rinse per the randomization schedule.
Examinations for the clinical endpoints (PI, GI and BI) will be conducted at the baseline, 3-month, and 6-month visits.
Interim visits will be scheduled to review diary, replenish study supplies, check study compliance, etc. Subjects will be provided Colgate Regular toothpaste, dental floss and a soft toothbrush (replaced at 3 months) for use during the 6-month study period.
Enrollment
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Inclusion criteria
Subjects to whom these criteria apply will be entered into the 7-day washout
Subjects must meet the screening inclusion criteria and these additional requirements for enrollment:
Exclusion criteria
Subjects to whom these conditions apply will be excluded:
Primary purpose
Allocation
Interventional model
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200 participants in 4 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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