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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
250
Subjects will brush and rinse with distilled water twice daily.
Subjects will brush and rinse with their assigned mouthwash twice daily.
Subjects will brush and rinse with their assigned mouthwash twice daily.
Subjects will brush and rinse with their assigned mouthwash twice daily.
Subjects will brush and rinse with their assigned mouthwash twice daily.
The ADA Forsyth Institute
Somerville, Massachusetts, United States
RECRUITINGChanges in profiles in supragingival plaque microbiome samples
Microbiome analysis will be conducted by ADA-Forsyth's Oral Microbiome Core.
Time frame: Baseline (Day 0) and after 4 weeks (Day 28 ± 2 days)
Changes in microbiome profiles - Subgingival plaque samples - Saliva samples -Tongue biofilm samples
Microbiome analysis will be conducted by ADA-Forsyth's Oral Microbiome Core
Time frame: Baseline (Day 0) and after 4 weeks (Day 28 ± 2 days)
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.
Time frame: Baseline (Day 0) and after 4 weeks (Day 28 ± 2 days)
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.
Time frame: Baseline (Day 0) and after 4 weeks (Day 28 ± 2 days
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.
Time frame: Baseline (Day 0) and after 4 weeks (Day 28 ± 2 days)
Changes in clinical periodontal parameters compared to baseline and a control group: • Bleeding on probing (BOP)
The BOP 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.
Time frame: Baseline (Day 0) and after 4 weeks (Day 28 ± 2 days)
Changes in clinical periodontal parameters compared to baseline and a control group • Gingival inflammation
Gingival inflammation measured by Modified Gingival Index (MGI)
Time frame: Baseline (Day 0) and after 4 weeks (Day 28 ± 2 days)
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