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

Water Pik

Status

Completed

Conditions

Gingivitis

Treatments

Device: Control

Device: Electric toothbrush

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04003298

26ORWF2019

Details and patient eligibility

About

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.

Full 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.

Enrollment

70 patients

Sex

All

Ages

25 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Be between 20 and 70 years of age
Be able to provide written informed consent prior to participation
Agree to not participate in any other oral/dental products clinical study for the study duration
Be in good general health and be a non-smoker
Have 50% bleeding on probing sites (moderate gingivitis)
Have no probing depths greater than 4 mm
Have a minimum of 20 teeth (not including 3rd molars)
No partial dentures, orthodontic brackets, wires or other appliances
Agree to refrain from the use of any non-study dental device or oral care product for the study duration
Agree to return for the scheduled visits and follow study procedures
Agree to delay dental prophylaxis until study completion
Have a minimum pre-brushing plaque score of 0.6
Have a minimum of 1.75 gingivitis score

Exclusion criteria

Have probing depth greater than 4 mm
Have a systemic disease (ex. Diabetes, autoimmune disease)
Have advanced periodontitis
Taking medication that can influence gingival health (ex. Dilantin, Procardia (calcium channel blockers), Cyclosporine, anticoagulants)
Have orthodontic appliances or removable partial dentures
Pregnant at time of study
Use of antibiotics within 6 months of study