Actively Recruiting
Comparison of the Effects of Oral Hygiene Regimens on Clinical, Immunomodulatory, and Microbial Outcomes and Oral Tolerance in People With Gingivitis
Led by Kenvue Brands LLC · Updated on 2026-03-30
250
Participants Needed
1
Research Sites
9 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a six-week, double-blind, randomized, parallel-group controlled clinical study. The objective of this study is to evaluate the changes to the oral microbiome, inflammatory mediators, gingival health indices and to assess oral tolerance after 4 weeks of twice daily use of differing oral hygiene regimens including mouthwash compared to a control group. A follow-up assessment will be completed 2 weeks after cessation of treatments.
CONDITIONS
Official Title
Comparison of the Effects of Oral Hygiene Regimens on Clinical, Immunomodulatory, and Microbial Outcomes and Oral Tolerance in People With Gingivitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adequate oral hygiene with daily tooth brushing and no severe oral neglect
- Mean Modified Gingival Index (MGI) of 2.00 or higher at screening and baseline
- Bleeding upon probing (BOP) of 30% or more at screening
- Diagnosis of gingivitis confirmed at screening and baseline visits
- Able to read and understand English
- Signed informed consent and agreed to study procedures including photo release and HIPAA
- Generally good overall health based on medical history
- At least 18 natural teeth excluding third molars with scorable facial and lingual surfaces
- Willing to use assigned oral hygiene products as instructed and available for appointments
- Likely to complete the clinical trial
You will not qualify if you...
- Significant oral soft tissue diseases or active tooth decay
- History of serious reactions or allergies to oral hygiene products or red food dye
- Periodontitis with more than 2 sites having probing depth over 4mm
- Regular use of probiotic supplements within 1 week before screening (rescreening allowed)
- Dental cleaning within 4 weeks before screening (rescreening allowed)
- Use of orthodontic devices or significant cosmetic dental restorations
- Medical conditions needing antibiotic coverage before dental work
- Use of tobacco, cannabis, smokeless tobacco, vaping, or e-cigarettes
- Suspected alcohol or substance abuse
- Unstable or uncontrolled medical conditions affecting study participation
- Self-reported Type 1 or Type 2 diabetes or use of anti-diabetic medications
- Use of medications masking adverse events or confounding results, including recent NSAIDs (except low-dose aspirin), immunosuppressants, steroids, anticoagulants, or antibiotics
- Pregnancy, lactation, or planning pregnancy; females must use effective contraception
- Participation in another clinical trial within 30 days before screening
- Previous participation in this study's treatment groups
- Related to study staff or employees involved in the study
- Living in the same household as another participant in the study at the same time
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The ADA Forsyth Institute
Somerville, Massachusetts, United States, 02143
Actively Recruiting
Research Team
K
Kenvue Global Clinical Operations
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
5
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here