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

Part of paid clinical trials in Somerville, Massachusetts.

Sponsor
Kenvue Brands LLC
Study ID
NCT07501455
Status
Recruiting
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Conditions

  • Cytokines
  • Gingival Bleeding
  • Gingivitis
  • Microbiome
  • Plaque

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • Distilled Water — OTHER
    Subjects will brush and rinse with distilled water twice daily.
  • Marketed Comparator 1 — OTHER
    Subjects will brush and rinse with their assigned mouthwash twice daily.
  • Marketed Comparator 2 — OTHER
    Subjects will brush and rinse with their assigned mouthwash twice daily.
  • Prototype Rinse 1 — OTHER
    Subjects will brush and rinse with their assigned mouthwash twice daily.
  • Prototype Rinse 2 — OTHER
    Subjects will brush and rinse with their assigned mouthwash twice daily.

Study Details

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.

Key Dates

Start date
Feb 26, 2026
Status verified
Mar 2026
Primary completion
May 5, 2026
Completion
May 5, 2026

Study Design

Enrollment
250 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

Primary Outcome Measure

Changes in profiles in supragingival plaque microbiome samples [ Time Frame: Baseline (Day 0) and after 4 weeks (Day 28 ± 2 days) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The ADA Forsyth InstituteSomervilleMassachusetts02143
Hatice Hasturk
[email protected]

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