Effect of Health Diary on Self-management in Adolescent Patients With Orthodontic Fixed Appliance: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Plaque Index
研究概览
简要总结
This study aims to use two-arm randomized clinical trials to evaluate the effectiveness of the health diary in helping adolescents wearing fixed orthodontic appliances improve their oral hygiene status, self-management skills, oral health-related quality of life, self-efficacy, intention，number of breakages, and on-time and return visit status.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Investigator)
盲法说明
A qualified examiner blinded to individual subject treatment assignments performed the oral hygiene status index （SBI and PLI）on subjects.
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with malocclusion eligible for fixed appliance orthodontic treatment;
- •The age of patients ranged from 12 to 18 years;
- •The patients received orthodontic treatment for the first time;
- •The patient was alert and had no cognitive or psychiatric impairment;
- •The patient was able to read and fill out the questionnaires, and had good listening, speaking and understanding skills in Chinese.
排除标准
- •The patient's disease was diagnosed as jaw deformity associated with other diseases. Malocclusion secondary to trauma, tumor, cleft lip and palate;
- •Patients treated with orthodontic-orthognathic surgery;
- •The patient currently participating in other oral related intervention studies.
结局指标
主要结局
Plaque Index
时间窗: Change from baseline plaque index at 24-weeks follow-up.
Ramfjord index teeth (16, 21, 24/25, 36, 41, 44/45) were selected. After staining with plaque stain, the plaque area of mesial, middle buccal, distal buccal and lingual surface of each tooth was examined, and the average value of the four dental surfaces was recorded. Finally, the PLI score was calculated by adding the index teeth and dividing by the number of teeth examined.
Bleeding Index
时间窗: Change from baseline plaque index at 24-weeks follow-up.
It is a combination of visual examination and probing. The probe was inserted into the gingival sulcus for 1 second and then removed. After 30 seconds, the gingival bleeding and the degree of bleeding were observed. Ramfjord index teeth were selected, namely 16, 21, 24/25, 41, 44/45.The detection sites of each index tooth included 6 sites in the mesial, distal and central of the buccal and lingual surface. The sum of the scores of the examined teeth and then divided by the number of examined teeth were used to determine the SBI score of the patient.
次要结局
- Self-Management Ability(Change from baseline plaque index at 24-weeks follow-up.)
- Self Efficacy(Change from baseline plaque index at 24-weeks follow-up.)
- The number of appliance damage in each follow-up period(The number of appliance damage in each follow-up period change over 24 weeks during intervention from baseline.)
- Oral Health Related Quality of Life(Change from baseline plaque index at 24-weeks follow-up.)
- On-time follow-up visits(On-time follow-up visits change over 24 weeks during intervention from baseline.)
研究者
Wei XIA, PhD
Association Professor
Sun Yat-sen University