Treatment of Malocclusion Class II/1 - Predictors for Seeking, Compliance and Outcome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- subscale functional limitations of CPQ 11-14 SF16
研究概览
简要总结
Aim: to search for reasons for seeking orthodontic treatment, compliance during orthodontic treatment, drop-out from orthodontic treatment and success of orthodontic treatment.
Methods: evaluation before, during and at the end of orthodontic treatment. Clinical and diagnostic evaluation of complexity before and at the end of orthodontic treatment, evaluation of awareness of treatment need, impact on social and psychological aspects, functional disturbances, impact of malocclusion on quality of life, social interaction, ability to perform daily activities.
详细描述
Data will include diagnostic measurements on study casts, x-rays, and data from questionnaires given to children and parents. Statistical analyses will explore predictors of treatment success with treatment need, compliance and psycho-social domains.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •distal molar occlusion, overjet >5 mm, cervical vertebral maturation method stages (CS) -CS2, CS3 or CS4
排除标准
- •mental retardation
结局指标
主要结局
subscale functional limitations of CPQ 11-14 SF16
时间窗: baseline
CPQ 11-14, answers on 5-point Likert scale (0-4), score range 0-16, higher score means greater impact of functional limitations on quality of life
subscale social well-being of CPQ 11-14 SF 16
时间窗: baseline
CPQ 11-14, answers on 5-point Likert scale (0-4), score range 0-16, higher score means greater impact of social well-being on quality of life
change in overjet
时间窗: change from baseline to one year of appliance wear
sagittal distance between upper and lower anterior teeth measured in mm
overall score of CPQ 11-14 SF 16 and SF8
时间窗: baseline
CPQ 11-14, answers on 5-point Likert scale (0-4), score range 0-32 for SF8 and 0-64 for SF16 (sum of all items in short-form 8 and 16 instruments), higher score means higher impact of oral disorders on quality of life
Overjet
时间窗: baseline
sagittal distance between upper and lower anterior teeth measured in mm
Child perception questionnaire age 11-14 (CPQ 11-14 SF16) , subscale measuring oral symptoms
时间窗: baseline
CPQ 11-14, answers on 5-point Likert scale (0-4), score range 0-16, higher score means greater impact of oral symptoms on quality of life
subscale emotional well-being of CPQ 11-14 SF16
时间窗: baseline
CPQ 11-14, answers on 5-point Likert scale (0-4), score range 0-16, higher score means greater impact of emotional wee-being on quality of life
Self-perceived satisfaction with dental appearance
时间窗: baseline
rating scale, answer on 5-point Likert scale (0-4), higher score means greater satisfaction with dental apperance
Self-perceived treatment need
时间窗: baseline
rating scale, answers on 5-point Likert scale (0-4), higher score means greater self-perceived treatment need
次要结局
- change in emotional well-being of CPQ(change from baseline to one year of appliance wear)
- overall score of P CPQ(baseline)
- parental emotions subscale of FIS(baseline)
- P CPQ, subscale functional limitations(baseline)
- P CPQ, subscale social well-being(baseline)
- financial burden subscale of FIS(baseline)
- overall score of FIS(baseline)
- Parental-Caregiver Perceptions Questionnaire (P CPQ), subscale oral symptoms(baseline)
- P CPQ, subscale emotional well-being(baseline)
- parental/family activity subscale of Family Impact Scale (FIS) questionnaire(baseline)
- change in oral symptoms of CPQ 11-14 SF16(change from baseline to one year of appliance wear)
- change in functional limitations of CPQ(change from baseline to one year of appliance wear)
- family conflict subscale of FIS(baseline)
- validation of P CPQ in Croatia(one year)
- change in social well-being of CPQ(change from baseline to one year of appliance wear)
- validation of CPQ 11-14 in Croatia(one year)
- validation of FIS in Croatia(one year)
- change in overall score of CPQ SF8(change from baseline to one year of appliance wear)
研究者
Visnja Katic
Post-doc
University of Rijeka