Oral Hygiene Compliance in Orthodontic Patients Using Active Reminders: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Gingival bleeding
研究概览
简要总结
The aim of the present study will be to determine if different forms of active reminders regarding oral hygiene compliance have an influence on the level of compliance within orthodontic patients
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 11 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with a complete natural dentition.
- •Patients who need to undergo orthodontic therapy using fixed appliances.
- •Good oral hygiene, with no signs and symptoms of periodontal disease.
- •Patients with no medical or mental problems.
排除标准
- •Patients with health risks associated with periodontal probing.
- •Syndromic patients ex; Down syndrome.
- •Previous orthodontic treatment.
- •Patients with carious teeth
结局指标
主要结局
Gingival bleeding
时间窗: up to 6 months
This will be assessed using the bleeding index (BI) upon probing the mesio-buccal, direct buccal, and disto-buccal aspects of the gingival sulci of the teeth. BI scoring ranges from 0-2; 0: no bleeding after 30 seconds, 1: bleeding after 30 seconds, 2: immediate bleeding
Gingival inflammation
时间窗: up to 6 months
This will be assessed using the modified gingival index (MGI). One MGI measurement of the buccal marginal gingiva for each tooth will be scored. Scoring ranges from 0-4 where 0 indicates absence of inflammation, 1: mild inflammation (marginal or papillary unit), 2: mild inflammation (entire marginal and papillary unit), 3: moderate inflammation, and 4: severe inflammation
Plaque accumulation
时间窗: up to 6 months
This will be assessed using the plaque index (PI). One PI measurement will be recorded for the buccal surface of each tooth. Scoring ranges from 0-5; where 0 indicates absence of plaque, 1: discontinuous plaque band at gingival margin, 2: up to 1 mm continuous plaque band at gingival margin, 3: plaque band wider than 1 mm but less than 1/3 of the surface, 4: plaque band between 1/3 and 2/3 of the surface, and 5: plaque covering 2/3 or more of the surface
Visual examination of white spot lesions
时间窗: up to 6 months
The presence of white spot lesions located on the buccal surface gingival to the archwire will be examined visually on the maxillary and mandibular six anterior teeth after being air dried for 5 seconds. Scoring ranges from 0-3; where 0: no visible white spot or surface disruption, 1: visible white spot without surface disruption, 2: visible white spot with roughened surface, 3: visible white spot requiring restoration.
次要结局
未报告次要终点
研究者
Nourhan M.Aly
Assistant Lecturer of Dental Public Health
University of Alexandria