Comparing mouthwashes and daily oral care routines for people with gingivitis

Comparison of the Effects of Oral Hygiene Regimens on Clinical, Immunomodulatory, and Microbial Outcomes and Oral Tolerance in People With Gingivitis

Over six weeks, adults with gingivitis will try different mouthwashes and oral hygiene routines to see if they reduce gum bleeding, change oral bacteria, and alter immune markers.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 250 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Kenvue Brands LLC (Industry-sponsored)
• Locations: 1 site (Somerville, Massachusetts)
• Trial ID: NCT07501455 on ClinicalTrials.gov

What this trial studies

This is a six-week, double-blind, randomized, parallel-group controlled trial in adults with gingivitis that tests twice-daily use of different oral hygiene regimens, including two prototype rinses, two marketed comparators, and distilled water. Participants use the assigned regimen for four weeks, with a follow-up visit two weeks after stopping treatments. Outcomes include changes in the oral microbiome, inflammatory mediators (cytokines), gingival health indices (MGI and bleeding on probing), and measures of oral tolerance. Eligible participants must have confirmed gingivitis (MGI ≥2.00 and BOP ≥30%) and at least 18 natural teeth.

Who should consider this trial

Good fit: Adults with gingivitis confirmed by MGI ≥2.00 and bleeding on probing ≥30%, who have at least 18 natural teeth and can attend visits in Somerville, MA, are ideal candidates.

Not a fit: People with periodontitis, fewer than 18 natural teeth, major systemic illnesses affecting oral health, or who cannot comply with twice-daily rinsing and follow-up visits are unlikely to receive benefit from this protocol.

Why it matters

Potential benefit: If successful, this could identify mouthwash or hygiene routines that lower gum inflammation and harmful bacteria, reducing bleeding and improving overall gum health.

How similar studies have performed: Previous trials have shown some mouthwashes can reduce plaque and gingivitis short-term, but effects on the oral microbiome, cytokine profiles, and oral tolerance are less well established.

Eligibility criteria

Inclusion Criteria:

2\. Adequate oral hygiene (i.e., brush teeth daily and exhibit no signs of gross oral neglect).

3\. Mean Modified Gingival Index (MGI) is greater than or equal to 2.00 at screening visit and reconfirmed at baseline visit.

4\. Bleeding upon probing (BOP) is greater than or equal to 30% at the screening visit.

5\. Diagnosis of gingivitis (confirmed by MGI and BOP) at the screening visit and reconfirmed at the baseline visit.

6\. Able to read and understand English. 7. Subject has signed the written informed consent (ICD) and indicated their agreement with the terms of the study and the study procedures listed and photograph release including the Health Insurance Portability and Accountability Act (HIPAA) disclosure prior to any study-related procedures.

8\. Generally, in good overall health based on the medical history reported by the subject.

9\. Has at least 18 natural teeth (not counting 3rd molars) with scorable facial and lingual surfaces.

10\. Willingness to use the assigned products according to instructions, availability for appointments, agreement to follow the subject responsibilities and likelihood of completing the clinical trial

Exclusion Criteria:

1. Significant oral soft tissue pathology or active dental caries, based on the dentist's visual examination and at the discretion of the Investigator.
2. History of significant adverse reactions, including sensitivity or suspected allergies, following use of oral hygiene products such as toothpastes, mouth rinses, and red food dye.
3. Periodontitis, as determined by more than 2 sites with a probing depth greater than 4mm.
4. Regular consumption of probiotics supplements within one week prior to screening. Subjects can be rescreened if they fulfill this criterion.
5. Dental prophylaxis within 4 weeks prior to screening. Subjects can be rescreened if they fulfill this criterion.
6. Subjects who wear orthodontic bands, fixed retainers, removable orthodontic appliances, clear aligners or night guards or subjects who have had significant (based on the examiner or PI's oral exam) cosmetic restorations.
7. History of medical conditions requiring prophylactic antibiotic coverage prior to dental procedures.
8. Self-reported tobacco, cannabis, smokeless tobacco use, including snuff, chewing tobacco, vaping, and e-cigarette usage.
9. Suspected alcohol or substance abuse.
10. Significant unstable or uncontrolled medical condition which may interfere with a subject's participation in the study, at the discretion of the Investigator, including a history of or a concurrent health/other condition/situation which may put the individual at significant risk, confound the study results, or interfere significantly with the individual's participation in the study.
11. Has self-reported Type 1 or Type 2 diabetes or is on an anti-diabetic medication (i.e., metformin, insulin, Glucophage, etc.)
12. Is taking a medication that would mask an Adverse Event (AE) or confound the study results, including:

    * Non-steroidal anti-inflammatory drugs within 5 days before Visit 1 (81mg of aspirin is allowed).\*
    * Use of Immunosuppressive, or steroidal drugs therapy during the study or within 2 months before Visit 2. \* Intermittent use (\<3 times per week) of certain anti-inflammatory medications is acceptable at the discretion of the investigator. Use of anticoagulant therapy within 1 month of screening visit or during the study.
    * Use of systemic antibiotics within 1 month of screening visit and during the entire study.
13. Is self-reported to be pregnant, in lactation, planning to become pregnant during the study, or positive pregnancy urine tests (females of child-bearing potential only):

    * For females: Postmenopausal state (i.e., at least 1 year without menses without an alternative medical condition prior to the first study IP administration) or premenopausal/perimenopausal state with an effective means of contraception.
    * Females of childbearing potential must be using a medically acceptable method of birth control for at least one month prior to Visit 1 and agree to continue using this method during their participation in the clinical trial. Medically acceptable forms of birth control that may be used by the subject and/or his/her partner include:

      * Double barrier method (condoms, diaphragm or cervical cap with spermicide)
      * Hormonal prescription contraceptives (i.e., oral, injectable, implanted, patch or vaginal ring hormone therapy)
      * Intrauterine device (IUD)
      * Surgical sterilization (e.g., vasectomy that has been confirmed effective by sperm count check, tubal ligation, hysterectomy and/or bilateral oophorectomy)
      * Abstinence
    * For males: No pregnant or lactating spouse or partner at screening and willingness to utilize an acceptable form of birth control with spouse or any potential partner during the study and for 30 days thereafter.
14. Participation in any clinical trial within 30 days of the Screening visit.
15. Subjects who were previously randomized into one of the study products as part of this study.
16. Subjects who are related to the people who are involved directly or indirectly with the conduct of this study (i.e., principal Investigator, sub-investigators, study coordinators, other site personnel, employees of Kenvue, contractors of Kenvue, and the families of each).
17. Subjects within the same household as other subjects enrolled in the study at the same time.

Where this trial is running

Somerville, Massachusetts

• The ADA Forsyth Institute — Somerville, Massachusetts, United States (Recruiting)

Study contacts

• Study coordinator: Kenvue Global Clinical Operations

Conditions Microbiome; Cytokines; Plaque; Gingivitis; Gingival Bleeding