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

Gingivitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04003298
• Other study ID #: 26ORWF2019
• Status: Completed
• Phase: N/A
• Start date: June 26, 2019
• Est. completion date: August 23, 2019

Study information

• Verified date: September 2019
• Source: Water Pik, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: August 23, 2019
• Est. primary completion date: July 26, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Gingivitis

Intervention

Device:
• Electric toothbrush
Electric toothbrush and power interdental device
• Control
Oscillating-rotating

Locations

Country	Name	City	State
Canada	All Sum Research Center Ltd.	Mississauga	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Water Pik, Inc.	All Sum Research Center Ltd.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change score in bleeding on probing measured at 6 sites per tooth from baseline and between groups at 4 weeks.	Bleeding on Probing	4 weeks
Primary	Mean change score in gingival inflammation from baseline and between groups measured by Modified Gingival Index at 4 weeks	Modified Gingival Index	4 weeks
Secondary	Mean change score in dental plaque from baseline and between groups measured by Rustogi Modification of the Navy Plaque Index at 4 weeks.	Rustogi Modification of the Navy Plaque Index	pre & post, 4 weeks