NCT02907450已完成不适用
TolTwiCare : Qualitative Evaluation Routine Care From Primary Tolerance of a Prefabricated and Removable Orthosis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- No appearance of more than one injury that can not be attributed to causes other than the orthosis
研究概览
简要总结
The TwiCare® device is a removable brace that can be used in orthopedic referred to stimulate mandibular growth or in interception / contention.
The proposed research project will focus initially on assessing the comfort and safety of TwiCare® device. The orthopedic efficiency therefore not part of this study.
The comfort and safety of the brace will be evaluated firstly by the practitioner during the visit control around 2 ½ months (or 11 weeks) after the start of the port of the device, and with the help of a questionnaire completed by the patient at home 3 weeks and 6 weeks after the start of the port of the device, and during the control visit at 11 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male or female patients, where the laying of a brace phase of interception or contention after dental-facial orthodontic treatment is indicated (an intended age range of 8-18 years, not exhaustive or limiting) , recipient of a social security scheme, for which a management of the orthosis is acquired.
- •incisor width compatible with the sizes of TwiCare® orthotics available, according to manufacturer's recommendations
- •patient in good general health
- •parent or guardian able to receive clear information, and express their opposition not to the patient's participation in this research
- •for patients with malocclusions, the incisors (maxillary and mandibular) should be aligned.
排除标准
- •General chronic health problem, unbalanced
- •obvious oral ventilation
- •history of temporomandibular dysfunction
- •nocturnal episodes of severe bruxism
- •unbalanced periodontal disease
- •allergies or intolerances known to one of the constituents of the orthosis
- •opposition of representatives of the parental authority (parent or guardian) or the patient himself at the patient's participation in this research
- •patient unable to respond to the questionnaire
- •monitoring difficulties (going on holiday, imminent change, remoteness, lack of motivation)
- •simultaneous participation in intervention research
- •pregnant Patient on examination of the latter, according to his age
- •Incisive (maxilla and / or mandible) unaligned
结局指标
主要结局
No appearance of more than one injury that can not be attributed to causes other than the orthosis
时间窗: 11 weeks
次要结局
- The subjective assessment of the compliance of wearing the brace by patient by self questionnaire(11 weeks)
- The support type envisaged endline by the doctor(11 weeks)
- The clinical evaluation of the compliance of the orthosis (occurrence of tooth movement, state of the brace, usual patient interview)(11 weeks)
- The subjective assessment of patient acceptability questionnaires self treatment(11 weeks)
研究者
研究点 (2)
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