Analysis of Changes in Electromyographic Activity in Aligner Treatment of Adult Patients With and Without Nocturnal Bruxism: Single-centre Interventional Case-control With Device
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Change in potentials recorded by Bruxoff ® in bruxism patients.
研究概览
简要总结
The purpose of the study is to evaluate the effectiveness of clear aligners on the symptoms and signs reported by bruxism patients.
The aim of the investigators is to evaluate the effect of treatment on the masticatory muscles and the changes related to the tropism of the masseter muscles using Bruxoff ® device, before and after the beginning of the therapy. Bruxoff ® is a holter that assesses the contractions of the masseter muscles and the heart during sleep.
The plan is to compare treatment with clear aligners for bruxism and non-bruxism patients.
The results will allow the investigators to evaluate the progress of clear aligner therapy in bruxism patients and compare them with those of non-bruxism patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Acceptance of the treatment plan with clear aligners;
- •Acceptance of informed consent to the study;
- •Subjects classified as bruxists based on the diagnostic criteria for sleep bruxism described by the American Academy of Sleeping Medicine.
- •Subjects who don't meet the criteria of sleep bruxism by American Academy of Sleeping Medicine in good health.
排除标准
- •Patients with morphological and structural alterations to the temporomandibular joint, e.g. Condillary hypertrophy;
- •Medical history of neurological diseases, mental disorders and sleep disturbances e.g. restless leg syndrome and insomnia;
- •Patients in therapy with myorelaxants or other medicines that affect chewing muscle activity;
- •Patients with pacemakers;
- •Patients with periodontal diseases;
- •Patients with ongoing orthodontic therapy or with prosthetic rehabilitation
结局指标
主要结局
Change in potentials recorded by Bruxoff ® in bruxism patients.
时间窗: The records with Bruxoff® device are made: before the beginning of the treatment with clear aligner (T0), after 2 months (T1) and after 6 months (T2) from the start of the therapy.
The primary outcome of the study is the change in potential recorded by Bruxoff®, defined as the variation in nocturnal masseter contraction activity just in bruxism patients treated with aligners.The study aims to evaluate and compare diagnostic records measured with the Bruxoff® at three time points. Each time, the Bruxoff® is used two nights in a row. The purpose of the first night's data collection is to help the patient learn how to apply and use the device to its fullest potential; only the data collected on the second night will be used in the study to determine whether or not the patient has bruxism. * The Bruxoff® device is initially administered for two consecutive nights before the start of aligner therapy (T0). * 2 months after starting clear aligner therapy (T1), Bruxoff® is given for two consecutive nights. * The last 2 records are registered 6 months after the beginning of the treatment with clear aligners (T2).
次要结局
- Change of signs and symptoms of bruxism(The clinical examinations are made: before the beginning of the treatment with clear aligner (T0), after 2 months (T1) and after 6 months (T2) from the start of the therapy.)