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
N/A
Total Duration
On this page
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 60 years
- Adequate oral hygiene with daily tooth brushing and no signs of severe oral neglect
- Mean Modified Gingival Index (MGI) of 2.00 or higher at screening and baseline
- Bleeding on probing (BOP) of 30% or more at screening
- Diagnosis of gingivitis confirmed by MGI and BOP at screening and baseline
- Able to read and understand English
- Signed informed consent and agreed to study procedures and photo release
- Generally in good overall health
- At least 18 natural teeth (excluding third molars) with scorable facial and lingual surfaces
- Willing to use assigned products as directed and attend all appointments
- Likely to complete the clinical trial
You will not qualify if you...
- Significant oral soft tissue disease or active tooth decay
- History of adverse reactions or allergies to oral hygiene products or red food dye
- Periodontitis with more than two sites having probing depth greater than 4 mm
- Regular probiotic supplement use within one week before screening
- Dental cleaning within four weeks before screening
- Wearing orthodontic bands, retainers, removable appliances, clear aligners, night guards, or significant cosmetic dental work
- Medical conditions requiring preventive antibiotics before dental work
- Use of tobacco, cannabis, smokeless tobacco, vaping, or e-cigarettes
- Suspected alcohol or substance abuse
- Unstable or uncontrolled medical conditions that may affect participation
- Diabetes or use of anti-diabetic medication
- Use of medications masking adverse events or affecting study results, including recent NSAIDs, immunosuppressive, steroidal, anticoagulant, or systemic antibiotics
- Pregnancy, lactation, or planning pregnancy during the study
- For females, must be postmenopausal or use effective birth control methods
- For males, must have no pregnant or lactating partner and use birth control during study and 30 days after
- Participation in another clinical trial within 30 days before screening
- Previously randomized in this study
- Related to study personnel or employees of the sponsor
- Living in the same household as another participant enrolled at the same time
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants brush twice daily for one minute with provided toothpaste and toothbrush, then rinse with their assigned mouthwash or distilled water. They complete their oral care regimen for the first time at the site under supervision and record their twice-daily product usage in a diary at home.
1 baseline visit and 1 follow-up visit
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
5
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