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.
None
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.
Parallel
Distilled Water
Other interventionSubjects will brush and rinse with distilled water twice daily.
Marketed Comparator 1
Other interventionSubjects will brush and rinse with their assigned mouthwash twice daily.
Marketed Comparator 2
Other interventionSubjects will brush and rinse with their assigned mouthwash twice daily.
Prototype Rinse 1
Other interventionSubjects will brush and rinse with their assigned mouthwash twice daily.
Prototype Rinse 2
Other interventionSubjects will brush and rinse with their assigned mouthwash twice daily.
Changes in profiles in supragingival plaque microbiome samples
Microbiome analysis will be conducted by ADA-Forsyth's Oral Microbiome Core.
Changes in microbiome profiles - Subgingival plaque samples - Saliva samples -Tongue biofilm samples
Microbiome analysis will be conducted by ADA-Forsyth's Oral Microbiome Core
Changes in clinical periodontal parameters compared to baseline and a control grop: • Expanded Bleeding Index (EBI)
The EBI will be analyzed using analysis of co-variance (ANCOVA) with investigational product as a factor and baseline as covariate Between-group comparison of each investigational group versus negative control or each marketed control group will be performed in the model.
Changes in clinical periodontal parameters compared to baseline and a control group: • Amount of plaque measured by Turesky modification of Quigley-Hein Plaque Index (TPI)
The TPI will be analyzed using analysis of co-variance (ANCOVA) with investigational product as a factor and baseline as covariate Between-group comparison of each investigational group versus negative control or each marketed control group will be performed in the model.
Changes in clinical periodontal parameters compared to baseline and a control group: • Periodontal pocket depth
The periodontal pocket depth will be analyzed using analysis of co-variance (ANCOVA) with investigational product as a factor and baseline as covariate Between-group comparison of each investigational group versus negative control or each marketed control group will be performed in the model.
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