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

NCT07501455 | Recruiting

• 1 other identifier: CS2025OC100266
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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

Microbiome; Cytokines; Plaque; Gingivitis; Gingival Bleeding

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Changes in microbiome profiles - Subgingival plaque samples - Saliva samples -Tongue biofilm samples

  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)

  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)

  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

  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)

  Baseline (Day 0) and after 4 weeks (Day 28 ± 2 days)

Study Arms (5)

Brush / Rinse (Distilled Water)

PLACEBO COMPARATOR

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

Brush / Rinse (Experimental Prototype 1)

EXPERIMENTAL

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

Brush / Rinse (Experimental Prototype 2)

EXPERIMENTAL

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

Brush / Rinse (Marketed Comparator 1)

ACTIVE COMPARATOR

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

Brush / Rinse (Marketed Comparator 2)

ACTIVE COMPARATOR

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

Interventions

Distilled Water OTHER

Subjects will brush and rinse with distilled water twice daily.

Brush / Rinse (Distilled Water)

Marketed Comparator 1 OTHER

Subjects will brush and rinse with their assigned mouthwash twice daily.

Brush / Rinse (Marketed Comparator 1)

Marketed Comparator 2 OTHER

Subjects will brush and rinse with their assigned mouthwash twice daily.

Brush / Rinse (Marketed Comparator 2)

Prototype Rinse 1 OTHER

Subjects will brush and rinse with their assigned mouthwash twice daily.

Brush / Rinse (Experimental Prototype 1)

Prototype Rinse 2 OTHER

Subjects will brush and rinse with their assigned mouthwash twice daily.

Brush / Rinse (Experimental Prototype 2)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. Adequate oral hygiene (i.e., brush teeth daily and exhibit no signs of gross oral neglect).
• \. Mean Modified Gingival Index (MGI) is greater than or equal to 2.00 at screening visit and reconfirmed at baseline visit.
• \. Bleeding upon probing (BOP) is greater than or equal to 30% at the screening visit.
• \. Diagnosis of gingivitis (confirmed by MGI and BOP) at the screening visit and reconfirmed at the baseline visit.
• \. 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.
• \. Generally, in good overall health based on the medical history reported by the subject.
• \. Has at least 18 natural teeth (not counting 3rd molars) with scorable facial and lingual surfaces.
• \. 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

You may not qualify if:

• Significant oral soft tissue pathology or active dental caries, based on the dentist's visual examination and at the discretion of the Investigator.
• 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.
• Periodontitis, as determined by more than 2 sites with a probing depth greater than 4mm.
• Regular consumption of probiotics supplements within one week prior to screening. Subjects can be rescreened if they fulfill this criterion.
• Dental prophylaxis within 4 weeks prior to screening. Subjects can be rescreened if they fulfill this criterion.
• 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.
• History of medical conditions requiring prophylactic antibiotic coverage prior to dental procedures.
• Self-reported tobacco, cannabis, smokeless tobacco use, including snuff, chewing tobacco, vaping, and e-cigarette usage.
• Suspected alcohol or substance abuse.
• 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.
• Has self-reported Type 1 or Type 2 diabetes or is on an anti-diabetic medication (i.e., metformin, insulin, Glucophage, etc.)
• 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.

Sponsors & Collaborators

• Kenvue Brands LLC: lead

Study Sites (1)

The ADA Forsyth Institute

Somerville, Massachusetts, 02143, United States

RECRUITING

MeSH Terms

Conditions

Plaque, Amyloid; Gingivitis; Gingival Hemorrhage

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Oral Hemorrhage; Hemorrhage; Pathologic Processes

Central Study Contacts

Kenvue Global Clinical Operations

CONTACT

18779295131; KenvueClinical_KV@kenvue.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2026
• First Posted: March 30, 2026
• Study Start: February 26, 2026
• Primary Completion: May 5, 2026
• Study Completion: May 5, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03-24

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)