Clinical Evaluation of the Safety and Efficacy of AutoBrush® 360° U-Shaped Sonic Toothbrush on Plaque and Gingivitis in a 30-Day Model
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Gingivitis: Modified Gingival Index (MGI)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Examiner-blind only, subjects will receive treatment assignment and instructions in a room separate from the examiner and exam area.
入排标准
- 年龄范围
- 5 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Gingivitis: Modified Gingival Index (MGI)
时间窗: Whole mouth mean change in MGI scores at Day 30.
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.
Plaque: Lobene-Soparkar Modification of Turesky Modification of Quigley-Hein Plaque Index (LSPI)
时间窗: Whole mouth mean change in LSPI scores at Day 30, immediate post-brushing (Pre- to Post-Brushing scores)
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.
次要结局
- Gingivitis(Change from Baseline at Day 15 and Day 30])
- Plaque(Change from Baseline at Day 15 and Day 30)
- Safety: gingival recession(Changes from Baseline at Day 15 and Day 30)
- Safety: gingival abrasion(Changes from Baseline at Day 15 and Day 30)