A Comparative Study of Electric Toothbrushes for the Efficacy Plaque Removal and the Effect on Plaque Accumulation and Gingivitis.

Study Overview
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Brief Summary
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It is well accepted that the greatest contributor to the health of the periodontium and dentition is regular and thorough dental plaque removal, typically by means of adequate toothbrushing. Although patients are typically informed about the risks of substandard oral hygiene and the contributing factors in oral/dental disease by dental professionals, research has shown that an undesirably high proportion of adults find thorough toothbrushing with a standard manual toothbrush to achieve a plaque-free state challenging, as evidenced by high worldwide levels of gingivitis and/or periodontitis.

Detailed Description
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The purpose of this study is to clinically evaluate the plaque removal efficacy of two electric powered toothbrushes after a single use, as well as the effect on plaque accumulation and gingivitis after 14 days and 30 days period. Simultaneously, a comparison against a manual toothbrush will be made. Study design: randomised, single blinded, parallel. After the screening procedure and based on inclusion requirements, all subjects will receive oral prophylaxis (T0) to ensure a baseline of 0 Plaque Index (PI) prior to the first appointment (T1). The subjects will be instructed not to use a tooth brush or any mechanical cleaning device until the initial PI and Gingival Indexes (GI) are taken at 24 hours after T0. The subjects will be randomized into 3 groups, and the will be provided one of the three evaluated toothbrushes, as well as toothpaste. All subjects will be using identical toothpaste and will receive oral hygiene instructions based on the manufacturer's recommendations. At T1 initial GI and PI will be taken prior to brushing followed by a second PI reading immediately after the first use of the power driven toothbrush. The subjects will be instructed to brush twice a day for a period of 2 minutes (following the programmed toothbrush timer) and refrain from using dental floss, tooth pick or any mechanical oral hygiene aid for the period of the study. On the second visit at 14 days (T2) and third visit at 30 days (T3), additional GI and PI readings will be taken and data will be recorded. All measurements and clinical examinations will be performed by a single blinded examiner. Evaluation on teeth will be made on six teeth #3,7,12,19,23 and 28 (mesio-buccal, buccal, disto-buccal and mesio-lingual, lingual, disto-lingual) following the Silness-Loe Index.

Official Title
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A Comparative Study of Electric Toothbrushes for the Efficacy Plaque Removal and the Effect on Plaque Accumulation and Gingivitis.

Conditions
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Dental Plaque Induced Gingivitis, Dental Plaque

Intervention / Treatment
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* Device: Oral B Healthy Clean Manual Toothbrush
* Device: BURST Sonic Oral Care
* Device: Philipps Sonicare DiamondClean 300 Series


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Good overall health At least 20 teeth present, not including 3rd Molars Non-smoker Exclusion Criteria: Poor manual dexterity or mentally handicap; Presence of removable intra-oral prosthesis Current orthodontic therapy Severe Periodontal condition or caries teeth in need of immediate attention Pregnant women Subjects that use medications that may effect oral health No Systemic diseases/conditions such as diabetes mellitus, heart disease. Use of plaque inhibiting toothpaste, mouthwash, interdental flossing in the period of the study

Ages Eligible for Study
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Minimum Age: 18 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Manual Toothbrush<br>Patients will be asked to use a manual toothbrush for 30 days | Device: Oral B Healthy Clean Manual Toothbrush<br>* Manual Toothbrush<br>|
| Active Comparator: Sonic Toothbrush<br>Patients will be asked to use a sonic toothbrush for 30 days | Device: BURST Sonic Oral Care<br>* Electric sonic toothbrush<br>|
| Active Comparator: Pulsating Toothbrush<br>Patients will be asked to use a pulsating toothbrush for 30 days | Device: Philipps Sonicare DiamondClean 300 Series<br>* Electric pulsating toothbrush<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plaque Index | plaque index as evaluated by Silness-Loe Index: index recording both soft debris and mineralized deposits on teeth (index 0 (no plaque) to 3). | Baseline, 1 month | 
| Gingival Index | gingival index as evaluated by Silness-Loe Index, Range 0-3: Score 0 = Normal gingiva. Score 1 = Mild inflammation - slight change in color, slight edema. No bleeding on probing. Score 2 = Moderate inflammation - redness, edema, glazing. Bleeding on probing. Score 3 = Severe inflammation - marked redness and edema, ulceration. Tendency toward spontaneous bleeding. | Baseline, 1 month |