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.

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.

Study Overview

• Status: Completed
• Conditions: Gingivitis
• Intervention / Treatment: Device: Electric toothbrush; Device: Control

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Mississauga, Ontario, Canada, L5N 6J2
      • All Sum Research Center Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Electric toothbrush and power interdental device	Device: Electric toothbrush; Electric toothbrush and power interdental device
Active Comparator: Electric toothbrush	Device: Control; Oscillating-rotating

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Water Pik, Inc.
• Collaborators: All Sum Research Center Ltd.
• Investigators: Study Director: Jimmy Qaqish, All Sum Research Center Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2019
• Primary Completion (Actual): July 26, 2019
• Study Completion (Actual): August 23, 2019

Study Registration Dates

• First Submitted: June 26, 2019
• First Submitted That Met QC Criteria: June 28, 2019
• First Posted (Actual): July 1, 2019

Study Record Updates

• Last Update Posted (Actual): September 16, 2019
• Last Update Submitted That Met QC Criteria: September 11, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Gingivitis
• Other Study ID Numbers: 26ORWF2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes