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Study Comparing Different Oral Hygiene Routines on Mouth Health and Immune Response in Adults with Gingivitis
Led by Kenvue Brands LLC · Updated on 2026-03-30
250
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of different oral hygiene routines on the oral microbiome, inflammation, and gum health in people with gingivitis. This six-week, double-blind, randomized study compares mouthwash use combined with toothbrushing to a control group. Participants will be assessed for changes after four weeks of twice-daily oral care and again two weeks after stopping treatment to check oral tolerance and lasting effects. Participants will receive toothpaste and a toothbrush to use throughout the study. They will brush twice daily for one minute and then rinse either with distilled water, an assigned mouthwash, or one of several experimental or marketed rinses depending on their group. The first use of the products occurs under supervision at the study site, and participants will keep a diary to record their twice-daily product use. Throughout the study, researchers will collect oral plaque and saliva samples to analyze changes in the microbiome and measure gum health using indices like bleeding on probing, plaque amount, pocket depth, and gingival inflammation. These assessments take place at the start and after four weeks of treatment. The study monitors participants for safety and adherence, with a total participation period of six weeks including follow-up two weeks after treatment ends.
CONDITIONS
Brief Title
Comparison of the Effects of Oral Hygiene Regimens on Clinical, Immunomodulatory, and Microbial Outcomes and Oral Tolerance in People With Gingivitis
Research Team
K
Kenvue Global Clinical Operations
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