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