Oral Health Related Quality of Life and Clinical Outcomes in Patients Undergoing Canine Disimpaction- A Randomized Control Trial.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Post- surgical Oral health based Quality of life (10th day after surgical exposure)(Annexure 1; page 4)
研究概览
简要总结
To test the null hypothesis that there are no differences in the OHRQOL and clinical outcomes in patients undergoing palatal canine disimpaction using either open or closed surgical method.
详细描述
The study design will be a unicentric, randomized controlled clinical trial involving 2 parallel groups. The protocol has been approved by local ethics committee of Jamia Millia Islamia and all participants will be provided with an informed consent agreement. The settings will be the orthodontic department of a dental teaching hospital (Faculty of Dentistry, Jamia Millia Islamia). Participants for the trial will be identified from treatment waiting lists and new patient clinics.
Proper randomization procedures and reporting include the following steps.
- Generation of the random allocation sequence, including details of any restrictions.
- Allocation concealment.
- Implementation of the random allocation sequence:
information on who generated the allocation sequence, who enrolled the participants, and who assigned them to their groups.
OPEN SURGICAL EXPOSURE
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 13 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with palatally ectopic maxillary canines who required surgical exposure and orthodontic alignment
- •Age 13-25 years Minimal orthodontic problems other than the ectopic canine
- •Good oral hygiene and motivated to wear fixed appliances for at least 2 years
排除标准
- •Compromising medical conditions (patients requiring antibiotic prophylaxis to prevent infective endocarditis)
- •Periodontal disease (bleeding on probing, pocket probing depths _3 mm and decreased bone levels as diagnosed from baseline panoramic imaging)
- •Cases in which the canine is to be brought into the position of the lateral incisor.
结局指标
主要结局
Post- surgical Oral health based Quality of life (10th day after surgical exposure)(Annexure 1; page 4)
时间窗: 10th day after surgical exposure
Post- surgical Oral health based Quality of life of patients undergoing canine disimpaction will be accessed by questionnaire and compared for both open and closed groups
Clinical outcomes - periodontal (Annexure 1; page 5)
时间窗: Three month post debond
Periodontal outcomes of disimpacted canines accessed clinically and compared for both open and closed groups; contralateral canine of maxillary arch will be control group.
Post- surgical Oral health based Quality of life (24 hours after surgical exposure) (Annexure 1; page 3)
时间窗: 24 hours after surgical exposure
Post- surgical Oral health based Quality of life of patients undergoing canine disimpaction will be accessed by questionnaire and compared for both open and closed groups
Oral health based Quality of life (Annexure 1; page 1 and page 2)
时间窗: pre-treatment and 1 month post treatment (average duration of treatment 18 months )
to evaluate change in Oral health based Quality of life of patients undergoing canine disimpaction will be accessed by questionnaire and compared for both groups
Maxillary canine aesthetic index (Annexure 1; page 7)
时间窗: one month after debond
comparision to control side with experimental side of both the groups
次要结局
未报告次要终点
研究者
DR.PANCHALI BATRA
Professor, Department of Orthodontics
Jamia Millia Islamia