Effectiveness of Dual Light Therapy Electric Toothbrush vs.Manual Toothbrush on Periodontal Health of Orthodontic Patients Undergoing Oral Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 198
- 试验地点
- 2
- 主要终点
- Löe and Silness Gingival Index
研究概览
简要总结
The study is a randomized clinical trial to compare the effectiveness of a dual light ultrasonic toothbrush on periodontal health in orthodontic patients undergoing surgery.
Patients with cleft lip and palate undergo bone graft and orthognathic surgery. The study will compare the periodontal outcomes in patients who use these toothbrushes during the post-surgical period.
详细描述
Pilot Study, Randomized Control Clinical Trial, study groups 1) Craniofacial and/or unilateral and bilateral cleft palate patients undergoing orthognathic surgery . 2) Craniofacial and/or unilateral and bilateral cleft palate patients undergoing bone-graft surgery 3) Craniofacial and/or unilateral and bilateral cleft palate patients with no pending surgery. Three Investigational device include Dual Light Therapy Sonic Toothbrush (BristlTM Toothbrush), Sonic Toothbrush(BRistlTM) and manual toothbrush to target disease gingivitis in 189 patients. Categorical variables scored from Plaque Index and Gingival Index will be analyzed using Fisher exact test and McNemar test. Parametric methods will be used to analyze data from Bleeding on Probing and Periodontal Probing Depth. To determine differences between groups and within each test at all time points, Student t-test will be used.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
盲法说明
randomized assignment of study ID number
入排标准
- 年龄范围
- 6 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient of record of the Craniofacial and Special Care Orthodontic Clinic at Children's Hospital Los Angeles
- •Between the ages of 6 and 20 years
- •Physical status of ASA I or II
- •Diagnosis of craniofacial and/or isolated, complete or incomplete, bilateral or unilateral cleft lip and palate
排除标准
- •physical inability to brush teeth
- •cognitive inability to comprehend and follow directions.
结局指标
主要结局
Löe and Silness Gingival Index
时间窗: 18 weeks, 6 weeks apart evaluations
This involves a two-step process: Step One (1): evaluation of the clinical appearance of the gingival tissue; and Step Two (2): assessment of inflammation based on induction of bleeding from probing11. Step One will not be accomplished chairside but will be measured using photographs; Step Two will be done chairside.
Bleeding index
时间窗: 18 weeks, 6 weeks apart evaluations
For Bleeding Index (Appendix IIC) and measurement of Probing Depth, the scorers will be calibrated following the Examiner Guide to Measuring Periodontal Parameters \& Indices11. Probing Depth will be measured using a University of North Carolina (UNC) #15 manual probe and a #5 mouth mirror
次要结局
- Turesky et al Modified Quigley-Hein Plaque Index and Modified Plaque Index for Orthodontic Patient(18 weeks, 6 week apart evaluations)
研究者
Stephen Yen
Associate Professor
Children's Hospital Los Angeles