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

NCT ID: NCT04003298

Last Updated: 2019-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-26
• Study Completion Date: 2019-08-23

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Electric toothbrush and power interdental device

Electric toothbrush and power interdental device

Group Type: EXPERIMENTAL

Electric toothbrush

Intervention Type: DEVICE

Electric toothbrush and power interdental device

Electric toothbrush

Electric toothbrush

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: DEVICE

Oscillating-rotating

Interventions

Electric toothbrush

Electric toothbrush and power interdental device

Intervention Type: DEVICE

Control

Oscillating-rotating

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

All Sum Research Center Ltd.

OTHER

Sponsor Role: collaborator

Water Pik, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jimmy Qaqish

Role: STUDY_DIRECTOR

All Sum Research Center Ltd.

Locations

All Sum Research Center Ltd.

Mississauga, Ontario, Canada

Countries

Canada

Other Identifiers

26ORWF2019

Identifier Type: -

Identifier Source: org_study_id