Effects of the Continuous Wear of Invisalign® Trays on the Temporomandibular Joints and Orofacial Muscular Complex
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Effects of the continuous wear of Invisalign® trays on the temporomandibular joints and orofacial muscular complex
研究概览
简要总结
The purpose of this study is to assess temporomandibular joint (TMJ) symptoms and night muscle activity in an objective manner, in addition to daytime bruxism and clenching, as reported by the patient, following the start of orthodontic treatment with Invisalign®. A baseline evaluation of all measures will be used as control data, while different time points will be used to evaluate the evolution of patients' symptoms over the course of six months (the duration of the study).
详细描述
The aim of the study is to evaluate the effects of orthodontic treatment using Invisalign® on the temporomandibular joint (TMJ) and orofacial muscular complex, on the recorded number of bruxism/clenching events during sleep, and on the reported amount of bruxism/clenching events during the day.
Principal objective:
* Evaluation of the effect of continuous wear of Invisalign® trays on the TMJ and muscles of the orofacial complex.
Secondary objectives:
- Objective evaluation of the effect of Invisalign® trays on bruxism/clenching events at night.
- Subjective evaluation of the effect of Invisalign® trays on bruxism/clenching during the day.
- Evaluation of the evolution of symptoms over the course of six months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Permanent dentition
- •No congenially permanent teeth missing (with the exception of 3rd molars)
- •Patient requiring a non-extraction orthodontic treatment
- •Patient followed by the University of Montreal port-graduate orthodontic clinic
- •Cl.I skeletal relation (or mild cl.II / mild cl.III)
- •Patient can speak and read french
- •In good health
- •Patient and parents accept and sign informed consent form.
- •Periodontal health permits orthodontic treatment
- •Adequate oral hygiene
排除标准
- •Diagnosed TMJ's dysfunction
- •Severe TMJ's dysfunction
- •Lack of attendance
结局指标
主要结局
Effects of the continuous wear of Invisalign® trays on the temporomandibular joints and orofacial muscular complex
时间窗: 6 months
RDC/TMD Research Diagnostic Criteria Method
次要结局
- Effects of the continuous wear of Invisalign® trays on the reported amount of bruxism/clenching during the day(6 months)
- Effects of the continuous wear of Invisalign® trays on the number of bruxism/clenching events during sleep(6 months)
研究者
Andrée Montpetit
Assistant professor, Doctor of Dental Medecine
Université de Montréal