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

NCT07501455 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2026-03-30

No results posted yet for this study

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

Interventions

OTHER

Distilled Water

Subjects will brush and rinse with distilled water twice daily.

OTHER

Marketed Comparator 1

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

OTHER

Marketed Comparator 2

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

OTHER

Prototype Rinse 1

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

OTHER

Prototype Rinse 2

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

Sponsors & Collaborators

  • Kenvue Brands LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-02-26
Primary Completion
2026-05-05
Completion
2026-05-05

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07501455 on ClinicalTrials.gov