Clinical trial NCT04003298: Efficacy of the Addition of a Power Interdental Device to an Electric Toothbrush on Gingival Health.
Official title: Efficacy of the Addition of a Power Interdental Device to an Electric Toothbrush on Gingival Health: a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingivitis
Lead sponsor: Water Pik, Inc.
Sponsor class: INDUSTRY
Collaborators: name: All Sum Research Center Ltd.
First posted: 2019-07-01
Enrollment: 70
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Mean change score in bleeding on probing measured at 6 sites per tooth from baseline and between groups at 4 weeks.
timeFrame: 4 weeks
measure: Mean change score in gingival inflammation from baseline and between groups measured by Modified Gingival Index at 4 weeks
timeFrame: 4 weeks
Secondary outcomes:
measure: Mean change score in dental plaque from baseline and between groups measured by Rustogi Modification of the Navy Plaque Index at 4 weeks.
timeFrame: pre & post, 4 weeks
Other outcomes:
Locations:
city: Mississauga
country: Canada
facility: All Sum Research Center Ltd.
state: Ontario
Study officials:
affiliation: All Sum Research Center Ltd.
name: Jimmy Qaqish
role: STUDY_DIRECTOR
References: