An interventional study of Power device A and Power device B in Gingivitis, sponsored by Water Pik, Inc.. Completed at 1 site in Canada. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-11.
Sponsored by Water Pik, Inc. · Not applicable, Interventional, and Treatment
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.
590 studies on the registry are indexed under Gingivitis; 104 are open to participants now.
This study's enrollment of 105 is above the median of 64 across 478 interventional studies indexed under Gingivitis.
Browse Gingivitis studies →Water Pik, Inc. is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
sonic toothbrush used for 2 minutes and water flosser used for 1 minute
Device: Power device A
sonic toothbrush used for 2 minutes and water flosser used for 1 minute
Device: Power device B
American Dental Association standard manual toothbrush used for 2 minutes and dental floss all teeth
Device: Routine Oral Hygiene
Oral hygiene regimen completed daily
Oral hygiene regimen completed daily
Oral hygiene regimen completed daily
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
This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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Water Pik, Inc.