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

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.

Eligibility

Age range

18–60 years

Sex

All

Healthy volunteers

Yes

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.

Location