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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Gingivitis

Intervention / Treatment
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* Device: Electric toothbrush
* Device: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electric toothbrush and power interdental device<br>Electric toothbrush and power interdental device | Device: Electric toothbrush<br>* Electric toothbrush and power interdental device<br>|
| Active Comparator: Electric toothbrush<br>Electric toothbrush | Device: Control<br>* Oscillating-rotating<br>|

What is the study measuring?
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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 |