All Sum Research Center
Mississauga, Ontario, L5N 6J2, Canada
NCT Number: NCT04804670
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).
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Notify Me18 year–70 year
All sexes
Interventional
Not applicable
Mississauga, Ontario, L5N 6J2, Canada
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Oral hygiene regimen completed daily
Oral hygiene regimen completed daily
Oral hygiene regimen completed daily
Time frame: 4 weeks
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
Index uses a 0 - 4 point scale
Time frame: 4 weeks
Each tooth is scored using 9 sections for the facial and lingual surfaces.
Water Pik, Inc.
Industry
To Determine the Effectiveness of a Sonic Toothbrush and Interdental Device With Different Toothbrush Designs to Brushing and Flossing on Plaque, Gingival Bleeding and Inflammation: a 4-week Randomized Controlled Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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