The study is designed to evaluate the clinical changes in gingival health by measuring the reduction of gingival bleeding and inflammation over 4 weeks. Additionally, plaque removal will be evaluated after a single use (part 1) and over 4 weeks (part 2).
Data will be analyzed and reported as mean. The target population is approximately 105 healthy adult volunteers. there will be three groups with 35 subjects per group. Subjects will be randomized using a simple random sample. A computer-generated randomization schedule will be prepared by the study statistician. Based on the randomization schedule, subjects will be randomly assigned in a 1:1:1 ratio. With 35 subjects per group, the study will have 90% power to detect an average reduction in the percent of sites with BOP of 25%. The primary outcome will be the reduction in the percentage of sites with bleeding on probing (BOP) after 4 weeks. Reduction in the percentage of sites with BOP after 2 weeks (+/- 2 days). Reduction in the Modified Gingival index after 2 (+/- 2 days) and 4 weeks (+/- 2 days). Reduction in Rustogi Modification of Navy Plaque Index pre \& Post, 2 weeks (+/- 2 days) and 4 weeks (+/- 2 days). Data will include whole mouth, approximal, marginal, facial, and lingual analysis for all indices. Intraoral examination will be performed and any adverse events will be reported and followed-up. Subjects will complete a questionnaure at the completion of the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
105
Oral hygiene regimen completed daily
Oral hygiene regimen completed daily
Oral hygiene regimen completed daily
All Sum Research Center
Mississauga, Ontario, Canada
Bleeding on Probing
Binary measure of present = 1 or absent =0. Mean score is determined by adding the total number of sites with bleeding (six per tooth) and dividing by the total evaluable sites.
Time frame: 4 weeks
Modified Gingival Index
Index uses a 0 - 4 point scale
Time frame: 4 weeks
Rustogi Modification of the Navy Plaque Index
Each tooth is scored using 9 sections for the facial and lingual surfaces.
Time frame: 4 weeks
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