Clinical Study to Evaluate the Effectiveness of a Cognitive Behavioral Intervention (CBI) Adjunctive to a Smart Powered Toothbrush on the Oral Health of Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Gingival inflammation
研究概览
简要总结
This is a Phase III, randomized, one-center, three arm parallel group, open label and single blind clinical study to evaluate the effectiveness of a cognitive behavioral intervention (CBI) adjunctive to a smart powered toothbrush on the oral health of adolescents.
详细描述
This is a Phase III, randomized, one-center, three arm parallel group, open label and single blind clinical study to evaluate the effectiveness of a cognitive behavioral intervention (CBI) adjunctive to a smart powered toothbrush on the oral health of adolescents. Outcomes briefly summarized include the plaque score, gingival score and a survey of knowledge, attitudes and procedures measured at 1,3 and 6 months
Participating subjects will be randomized to one of the following products:
TEST GROUP I A commercially available fluoride toothpaste (1450 ppm F) A commercially available Smart Electric toothbrush CONTROL GROUP I A commercially available fluoride toothpaste (1450 ppm F) A commercially available Smart Electric toothbrush CONTROL GROUP II A commercially available fluoride toothpaste (1450 ppm F) A commercially available soft bristle 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
- None (Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Students are enrolled in participating high schools Caregivers give informed consent Student gives assent
排除标准
- •Having a prosthetic heart valve
- •Having a history of previously having infective endocarditis
- •Having had joint replacement surgery
- •Children on blood thinner medication such as Coumadin or Rivaroxaban
- •Children who are currently receiving chemotherapy
- •Children who have received organ transplants of any type
- •Children with Leukemia
结局指标
主要结局
Gingival inflammation
时间窗: All outcomes will be measured at baseline, at1 month, 3 months and at 6 months
A Löe-Silness Gingival Index score from 0 to 3 will be assigned by the examining dentist to all scorable surfaces of the maxillary and mandibular teeth using a dental light and dental mirror. A whole mouth mean score for each subject will be determined by adding the values given by the examining dentist to each scorable surface and dividing that number by the total number of surfaces scored. Scores Criteria 0 Absence of inflammation 1. Mild inflammation- Slight change in color and mild edema with little change in texture. No bleeding on probing. 2. Moderate inflammation- moderate glazing, redness, edema and hypertrophy. Bleeding on probing. 3. Severe inflammation- Marked redness, hypertrophy, edema and ulceration. Tendency for spontaneous bleeding.
次要结局
- Knowledge assessment(All outcomes will be measured at baseline, 1 month, 3 months and at 6 months)
- Motivation assessment(All outcomes will be measured at baseline, 1 month, 3months and at 6 months)
- Plaque scores(All outcomes will be measured at baseline, 1 month, 3 months and at 6 months)
- Efficacy assessment(All outcomes will be measured at baseline, 1 month, 3months and at 6 months)
研究者
Brian Laurence
Professor
Howard University