Comparison of the Effects of Oral Hygiene Regimens on Clinical, Immunomodulatory, and Microbial Outcomes and Oral Tolerance in People With Gingivitis
Recruiting
N/A
Interventional Study
Microbiome
Cytokines
Plaque
Gingivitis
Gingival Bleeding
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 18 – 60
- Sex
- Any
- Study type
- Interventional
- Purpose
- Basic Science
- Participants needed
- 250 (estimated)
- Sponsor
- Kenvue Brands LLC · Industry
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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 co…
Trial Locations
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Eligibility Criteria
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 equa…
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