Powertoothbrushing for Treating Gingivitis

Study Overview
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Brief Summary
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In this three-month interventional clinical trial for the treatment of gingivitis the investigators will assess the use of an oscillating-rotating powered toothbrush in comparison to the use of a manual toothbrush over 12-weeks in the absence of interproximal hygiene.

Detailed Description
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In this single-masked, parallel-armed, interventional clinical trial for treatment of gingivitis the investigators will assess the use of an oscillating-rotating powered toothbrush in comparison to the use of a manual toothbrush over 12-weeks in the absence of interproximal hygiene. The primary outcome variable is the change from baseline in the Modified Gingival Index at 2, 4 and 12-weeks from Baseline. Secondary outcome variables include change from baseline in bleeding on probing as well as change from baseline in the Turesky Modification of the Quigley-Hein Plaque index measuring overnight plaque formation. There will also be an assessment of single use efficacy in reduction of overnight plaque levels at the baseline visit t

Official Title
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Powertoothbrushing for Treating Gingivitis

Conditions
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Gingivitis

Intervention / Treatment
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* Device: Oscillating rotating power toothbrush


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A subject who meets all the following criteria will be eligible to enroll in this study. Age range 18 - 65 years Routine manual toothbrush user A Subject who agrees to use the assigned toothbrush as the only cleaning device for the study duration, refraining from daily interdental cleaning and/ or antiseptic mouthrinsing. Mild to moderate gingivitis as measured by A. Modified Gingival Index (MGI) average score of at least 1.2, and / or B. Bleeding on Probing (BOP) of at least 20% of all sites but not more than 50% of sites. Probing Pocket Depth (PPD) of 4 mm or lower At least 20 natural teeth - scoreable (crowns or bridgework are non-scoreable). Exclusion Criteria: Any subject meeting one of the following criteria will not be included in the study. Daily user of interdental cleaning devices, such as floss, floss picks, toothpicks, interdental brush, water flossing device Regular user of antimicrobial mouthrinses within one week of entry into study Professional prophylaxis within one month of entry into the study Use of antibiotics within one month prior to the baseline exam Signs of moderate to severe periodontitis or caries, categorized as PPD of 5 mm of higher and attachment loss of 3 mm or higher Subjects with orthodontic bands and/or dental appliances. Participated in an oral care related study in the last 90 days prior to this study Pregnant or lactating women Patients with a history of significant cardiovascular disease, diabetes, cancer, AIDS, or other organ impairment that would preclude their participation in the study Acute/concurrent illness such as hepatitis, herpes simplex infections, influenza, etc. History of rheumatic fever, cardiovascular valvular disease, artificial joint replacement or kidney or liver disorders Chronic use of steroids; limited use of NSAID's (≤ 325 mg/day) Current Smoker (within the last 3 months) Other medical or dental conditions that would affect the study Inability to commit to all necessary study visits from baseline to 12 weeks

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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
Interventional Model Description: 3 month home use parallel-arm design to assess the efficacy of powered toothbrush use in the treatment of gingivitis in a moderate sized population, n=70.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Powered toothbrush intervention<br>Subjects will be provided an oscillating rotating powered toothbrush as the experimental intervention, and given written instructions on its proper use. Efficacy of overnight plaque reduction will be assessed at baseline and both gingivitis and plaque reduction will be assessed as change from baseline at 2, 4 and 12 weeks. Subjects will be given a standard fluoride toothpaste and asked to refrain from daily interproximal plaque control for the duration of the study. | Device: Oscillating rotating power toothbrush<br>* a battery powered oscillating rotating toothbrush will be used for twice daily regular home dental hygiene<br>* Other names: powertoothbrush;|
| No Intervention: Manual toothbrush<br>Subjects will be provided a manual toothbrush as the control group and given written instructions on its proper use. Efficacy of overnight plaque reduction will be assessed at baseline and both gingivitis and plaque reduction will be assessed as change from baseline at 2, 4 and 12 weeks. Subjects will be given a standard fluoride toothpaste and asked to refrain from daily interproximal plaque control for the duration of the study. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Gingivitis | Baseline and 12 weeks post-baseline measures. Proportion of bleeding sites per patient was used as Full mouth BOP Score. The score for each site was either 1 for bleeding and 0 for no bleeding. Following is the full description of each outcome measure reported in the protocol. The Modified Gingival Index3 (MGI) will be measured on six sites - mesio-buccal, buccal, disto-buccal, mesio-lingual, lingual and disto-lingual - of all teeth using a 0-4 scale. Lower score no inflamation and higher severe inflammation. Dental plaque will be evaluated using the Lobene modification4 of the Turesky modification of the Quigley-Hein Plaque Index (PI)5. The score 0 to 5. Lower score means no plaque and higher score increasing plaque.Full-mouth Probing Pocket Depth (PPD) will be measured on the six locations of each tooth (mesial-buccal, buccal, distal-buccal, mesial-lingual, lingual, distal-lingual) using a periodontal probe. | 12 weeks post-baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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power toothbrush, oscillating rotating