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

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.

Study Overview

• Status: Recruiting
• Conditions: Gingivitis; Plaque; Cytokines; Microbiome; Gingival Bleeding
• Intervention / Treatment: Other: Distilled Water; Other: Prototype Rinse 1; Other: Prototype Rinse 2; Other: Marketed Comparator 1; Other: Marketed Comparator 2

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kenvue Global Clinical Operations; Phone Number: 18779295131; Email: KenvueClinical_KV@kenvue.com

Study Locations

• United States
  • Massachusetts
    • Somerville, Massachusetts, United States, 02143
      • Recruiting
      • The ADA Forsyth Institute
      • Contact: Hatice Hasturk; Email: hhasturk@forsyth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Brush / Rinse (Distilled Water); All subjects will receive 2 tubes of a marketed fluoride-containing dentifrice (Crest® Cavity Protection Toothpaste) and 1 soft, flat trimmed bristled toothbrush at their Baseline visit to use throughout the study. The subjects will use their assigned study products and complete their oral care regimen for the first time at the site under supervision. At home, subjects will brush twice daily for one-timed minute with the toothpaste and toothbrush provided. After brushing for 1-timed minute, subjects will rinse with provided distilled water according to the label instructions. Subjects will be required to record their twice-daily product usage in a subject diary.	Other: Distilled Water; Subjects will brush and rinse with distilled water twice daily.
Experimental: Brush / Rinse (Experimental Prototype 1); All subjects will receive 2 tubes of a marketed fluoride-containing dentifrice (Crest® Cavity Protection Toothpaste) and 1 soft, flat trimmed bristled toothbrush at their Baseline visit to use throughout the study. The subjects will use their assigned study products and complete their oral care regimen for the first time at the site under supervision. At home, subjects will brush twice daily for one-timed minute with the toothpaste and toothbrush provided. After brushing for 1-timed minute, subjects will rinse with their assigned mouthrinse according to the label instructions. Subjects will be required to record their twice-daily product usage in a subject diary.	Other: Prototype Rinse 1; Subjects will brush and rinse with their assigned mouthwash twice daily.
Experimental: Brush / Rinse (Experimental Prototype 2); All subjects will receive 2 tubes of a marketed fluoride-containing dentifrice (Crest® Cavity Protection Toothpaste) and 1 soft, flat trimmed bristled toothbrush at their Baseline visit to use throughout the study. subjects will use their assigned study products and complete their oral care regimen for the first time at the site under supervision. At home, subjects will brush twice daily for one-timed minute with the toothpaste and toothbrush provided. They will place a full ribbon of toothpaste across the length of the provided toothbrush. After brushing for 1-timed minute, subjects will rinse with their assigned mouthrinse according to the label instructions. Subjects will be required to record their twice-daily product usage in a subject diary.	Other: Prototype Rinse 2; Subjects will brush and rinse with their assigned mouthwash twice daily.
Active Comparator: Brush / Rinse (Marketed Comparator 1); All subjects will receive 2 tubes of a marketed fluoride-containing dentifrice (Crest® Cavity Protection Toothpaste) and 1 soft, flat trimmed bristled toothbrush at their Baseline visit to use throughout the study. The subjects will use their assigned study products and complete their oral care regimen for the first time at the site under supervision. At home, subjects will brush twice daily for one-timed minute with the toothpaste and toothbrush provided. After brushing for 1-timed minute, subjects will rinse with their assigned mouthrinse according to the label instructions. Subjects will be required to record their twice-daily product usage in a subject diary.	Other: Marketed Comparator 1; Subjects will brush and rinse with their assigned mouthwash twice daily.
Active Comparator: Brush / Rinse (Marketed Comparator 2); All subjects will receive 2 tubes of a marketed fluoride-containing dentifrice (Crest® Cavity Protection Toothpaste) and 1 soft, flat trimmed bristled toothbrush at their Baseline visit to use throughout the study. The subjects will use their assigned study products and complete their oral care regimen for the first time at the site under supervision. At home, subjects will brush twice daily for one-timed minute with the toothpaste and toothbrush provided. After brushing for 1-timed minute, subjects will rinse with their assigned mouthrinse according to the label instructions. Subjects will be required to record their twice-daily product usage in a subject diary.	Other: Marketed Comparator 2; Subjects will brush and rinse with their assigned mouthwash twice daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in profiles in supragingival plaque microbiome samples	Microbiome analysis will be conducted by ADA-Forsyth's Oral Microbiome Core.	Baseline (Day 0) and after 4 weeks (Day 28 ± 2 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in microbiome profiles - Subgingival plaque samples - Saliva samples -Tongue biofilm samples	Microbiome analysis will be conducted by ADA-Forsyth's Oral Microbiome Core	Baseline (Day 0) and after 4 weeks (Day 28 ± 2 days)
Changes in clinical periodontal parameters compared to baseline and a control grop: • Expanded Bleeding Index (EBI)	The EBI will be analyzed using analysis of co-variance (ANCOVA) with investigational product as a factor and baseline as covariate Between-group comparison of each investigational group versus negative control or each marketed control group will be performed in the model.	Baseline (Day 0) and after 4 weeks (Day 28 ± 2 days)
Changes in clinical periodontal parameters compared to baseline and a control group: • Amount of plaque measured by Turesky modification of Quigley-Hein Plaque Index (TPI)	The TPI will be analyzed using analysis of co-variance (ANCOVA) with investigational product as a factor and baseline as covariate Between-group comparison of each investigational group versus negative control or each marketed control group will be performed in the model.	Baseline (Day 0) and after 4 weeks (Day 28 ± 2 days
Changes in clinical periodontal parameters compared to baseline and a control group: • Periodontal pocket depth	The periodontal pocket depth will be analyzed using analysis of co-variance (ANCOVA) with investigational product as a factor and baseline as covariate Between-group comparison of each investigational group versus negative control or each marketed control group will be performed in the model.	Baseline (Day 0) and after 4 weeks (Day 28 ± 2 days)
Changes in clinical periodontal parameters compared to baseline and a control group: • Bleeding on probing (BOP)	The BOP will be analyzed using analysis of co-variance (ANCOVA) with investigational product as a factor and baseline as covariate Between-group comparison of each investigational group versus negative control or each marketed control group will be performed in the model.	Baseline (Day 0) and after 4 weeks (Day 28 ± 2 days)
Changes in clinical periodontal parameters compared to baseline and a control group • Gingival inflammation	Gingival inflammation measured by Modified Gingival Index (MGI)	Baseline (Day 0) and after 4 weeks (Day 28 ± 2 days)

Collaborators and Investigators

• Sponsor: Kenvue Brands LLC

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2026
• Primary Completion (Estimated): May 5, 2026
• Study Completion (Estimated): May 5, 2026

Study Registration Dates

• First Submitted: March 6, 2026
• First Submitted That Met QC Criteria: March 26, 2026
• First Posted (Actual): March 30, 2026

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 24, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Anatomical; Infections; Hemorrhage; Gingival Diseases; Oral Hemorrhage; Pathological Conditions, Signs and Symptoms; Plaque, Amyloid; Gingivitis; Gingival Hemorrhage
• Other Study ID Numbers: CS2025OC100266

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No