Comparison of the Effects of Oral Hygiene Regimens on Clinical, Immunomodulatory, and Microbial Outcomes and Oral Tolerance in People With Gingivitis
Kenvue Brands LLC
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
Inclusion Criteria: 2\. Adequate oral hygiene (i.e., brush teeth daily and exhibit no signs of gross oral neglect). 3\. Mean Modified Gingival Index (MGI) is greater than or equal to 2.00 at screening visit and reconfirmed at baseline visit. 4\. Bleeding upon probing (BOP) is greater than or equal to 30% at the screening visit. 5\. Diagnosis of gingivitis (confirmed by MGI and BOP) at the screening visit and reconfirmed at the baseline visit. 6\. Able to read and understand English. 7. Subject has signed the written informed consent (ICD) and indicated their agreement with the terms of th…
Interventions
- OtherDistilled Water
Subjects will brush and rinse with distilled water twice daily.
- OtherMarketed Comparator 1
Subjects will brush and rinse with their assigned mouthwash twice daily.
- OtherMarketed Comparator 2
Subjects will brush and rinse with their assigned mouthwash twice daily.
- OtherPrototype Rinse 1
Subjects will brush and rinse with their assigned mouthwash twice daily.
- OtherPrototype Rinse 2
Subjects will brush and rinse with their assigned mouthwash twice daily.
Location
- The ADA Forsyth InstituteSomerville, Massachusetts