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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorKenvue Brands LLC

About this trial

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.

Eligibility criteria

Qualifiers

None

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Distilled Water
  • Marketed Comparator 1
  • Marketed Comparator 2
  • Prototype Rinse 1
  • Prototype Rinse 2

Treatment groups

250 Participants
are divided into 5 treatment groups

Sponsors and collaborators