NCT04003298

Efficacy of the Addition of a Power Interdental Device to an Electric Toothbrush on Gingival Health.

Efficacy of the Addition of a Power Interdental Device to an Electric Toothbrush on Gingival Health: a Randomized Controlled Trial.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Water Pik, Inc. · Industry
• Sex: All
• Age: 25 Years – 70 Years
• Healthy volunteers: Accepted

Summary

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 and over 4 weeks.

Detailed description

Data will be analyzed and reported as mean. The target population is approximately 70 healthy adult volunteers. There will be two groups with a total of 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, patients will be randomly assigned in a 1:1 ratio to receive either: 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 MGI after 2 (+/- 2 days) and 4 weeks. Reduction in RMNPI Pre \& post, 2 weeks 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 questionnaire at the completion of the study.

Conditions

• Gingivitis

Interventions

Type	Name	Description
DEVICE	Electric toothbrush	Electric toothbrush and power interdental device
DEVICE	Control	Oscillating-rotating

Timeline

• Start date: 2019-06-26
• Primary completion: 2019-07-26
• Completion: 2019-08-23
• First posted: 2019-07-01
• Last updated: 2019-09-16

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated device study