Safety and Efficacy of U-Shaped Sonic Toothbrush on Plaque and Gingivitis

Study Overview
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Brief Summary
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The goal of this 30 day, randomized, two group, parallel, examiner-blind clinical study is to evaluate the safety and efficacy of AutoBrush® 360° U-shaped Sonic Toothbrush on supragingival dental plaque and gingivitis, compared to an American Dental Association (ADA) reference manual soft toothbrush. The extent of gingival abrasion and recession and oral safety will be evaluated.

Detailed Description
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This single-center, randomized, controlled, examiner-blind, 30-day parallel designs study will consist of Screening and Baseline visits with approximately 80 subjects (age 5-65 years) who will read and sign an informed consent form and assent form, be assessed for evidence of gingivitis and plaque according to the Modified Gingival Index (MGI) and the Lobene-Soparkar Modification of Turesky Modified Quigley-Hein Plaque Index (LSPI) at Baseline, and days 15 and 30 post-baseline. Oral safety, gingival recession and gingival abrasion will be measured at all visits. Subjects will be randomly assigned to one of two groups: twice daily brushing with a fluoride toothpaste and 1) two-minute brushing with ADA reference standard manual toothbrush, or 2) 30-second brushing with AutoBrush® 360° U-shaped Sonic Toothbrush.

Official Title
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Clinical Evaluation of the Safety and Efficacy of AutoBrush® 360° U-Shaped Sonic Toothbrush on Plaque and Gingivitis in a 30-Day Model

Conditions
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Plaque Induced Gingivitis

Intervention / Treatment
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* Device: Power sonic toothbrush
* Device: Manual toothbrush


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: generally healthy males and females at least 5 to 65 years of age. If under age 18, willing to provide assent to participate and consent from a parent or legal guardian prior to being entered into the study; If 18 years of age or older, is able to read, sign and receive a copy of the signed informed consent form. regular manual toothbrush users and able to brush their own teeth on a daily basis. In good health based on medical history review by the investigator. willing to refrain from all oral hygiene for approximately 12-16 hours prior to each study visit and discontinue eating and drinking for approximately 30 minutes prior to each study visit, with the exception of sips of water. Have a minimum of 18 natural teeth, in the adult dentition, with scorable facial and lingual surfaces. If under the age of 12, must have at least 12 fully erupted teeth, primary or permanent teeth. Partially erupted permanent teeth and primary teeth that are loose or in process of exfoliation will not be included in the tooth count. Teeth that are grossly carious, orthodontically banded, exhibiting general cervical abrasion and/or enamel abrasion, > 2 mm gingival recession will not be included in the tooth count. Present with a gingival index score ≥ 1.75 according to the Modified Gingival Index at Baseline, a plaque index score > 1.80 according to the Lobene-Soparkar Modification of the Turesky Modification of the Quigley-Hein Plaque Index, following a 12 to 16-hour plaque accumulation period at Baseline. willing and able to refrain from dental treatment during the course of the study, except on an emergency basis. Exclusion Criteria: history of adverse effects, oral soft or hard tissue sensitivity, to any ingredient in the test materials. Self-reported serious medical conditions. Self-reported as pregnant or nursing. Under treatment for a heart condition requiring use of pacemaker. Have any condition, in the opinion of the investigator, that would place the subject at increased risk or preclude the subject's full compliance with or completion of the study? Require antibiotic premedication prior to dental procedures. Have had antibiotic, anti-inflammatory, anti-coagulant medication or chemotherapeutic antiplaque/antigingivitis therapy within 30 days of screening exams. participated in any study involving oral care products, concurrently or within the 30 days of screening exams. Unwilling to discontinue use of other oral hygiene products for the duration of the study. Present use of any tobacco products. Presence of severe periodontal disease or being actively treated for periodontal disease. Have grossly carious, fully crowned, or extensively restored teeth. Have orthodontic appliances, peri/oral piercings, or removable partial dentures. Have significant oral soft tissue pathology based on a visual examination.

Ages Eligible for Study
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Minimum Age: 5 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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: U-shaped power toothbrush<br>Device: U-shaped Power Toothbrush with fluoride toothpaste | Device: Power sonic toothbrush<br>* Subjects will brush twice daily for 30 seconds using a fluoride toothpaste.<br>* Other names: AutoBrush 360 U-Shaped power toothbrush;|
| Placebo Comparator: Manual Toothbrush<br>Device: Soft Manual Toothbrush with fluoride toothpaste | Device: Manual toothbrush<br>* Subjects will brush twice daily for 2 minutes using a fluoride toothpaste.<br>* Other names: ADA Reference standard soft manual toothbrush;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gingivitis: Modified Gingival Index (MGI) | Gingival Inflammation, assessed on a 5-point scale (0 to 4), will be scored in six areas (disto-buccal, mid-buccal and mesio-buccal, disto-lingual, mid-lingual and mesio-lingual) of all scorable teeth using criteria: 0 = Normal (absence of inflammation), 1 = Mild inflammation (slight change in color, little change in texture) of any portion of the entire gingival unit; 2 = Mild inflammation of the entire gingival unit; 3 = Moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the gingival unit; 4 = Severe inflammation (marked redness and edema/hypertrophy, spontaneous bleeding, or ulceration) of the gingival unit. | Whole mouth mean change in MGI scores at Day 30. | 
| Plaque: Lobene-Soparkar Modification of Turesky Modification of Quigley-Hein Plaque Index (LSPI) | Plaque will be disclosed using a red disclosing solution and each tooth will be scored in six areas (disto-buccal, mid-buccal and mesio-buccal, disto-lingual, mid-lingual and mesio-lingual), according to the criteria noted below: 0 = No plaque; 1 = Separate flecks or discontinuous band of plaque at the gingival (cervical) margin; 2 = Thin (up to 1 mm), continuous band of plaque at the gingival margin; 3 = Band of plaque wider than 1 mm but less than 1/3 of tooth surface area; 4 = Plaque covering 1/3 or more, but less than 2/3 of tooth surface area; 5 = Plaque covering 2/3 or more of tooth surface area. | Whole mouth mean change in LSPI scores at Day 30, immediate post-brushing (Pre- to Post-Brushing scores) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gingivitis | Whole mouth MGI, Gumline MGI, Proximal, Mean distal score of the last posterior tooth in each quadrant. | Change from Baseline at Day 15 and Day 30] | 
| Plaque | LSPI: Whole mouth, Gumline, Proximal, distal score of the last posterior tooth in each quadrant. | Change from Baseline at Day 15 and Day 30 | 
| Safety: gingival recession | Gingival recession measurements (mm) will be carried out at six sites per tooth (mesio-buccal, mid-buccal, distobuccal, mesio-lingual, mid-lingual, and disto-lingual). Recession will be measured as the visible distance from the cemento-enamel junction (CEJ) to the gingival margin. | Changes from Baseline at Day 15 and Day 30 | 
| Safety: gingival abrasion | Gingival Abrasion will be assessed with a 2-tone disclosing solution to help visualize abraded areas of the oral epithelium. Gingival tissues of each tooth will be divided into 3 areas on both the facial and lingual surfaces, as illustrated in Fig. 1: marginal (cervical free gingiva), interdental (papillary free gingiva) and mid-gingival (attached gingiva). If abrasion is present, the site will be recorded as small (≤2 mm), medium (3-5 mm) and large (>5 mm). If no abrasion is present, the site will be recorded as 0. | Changes from Baseline at Day 15 and Day 30 |