Efficiency of Neuromuscular Bite vs Physiotherapy in TMD Patients BENEFIT Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- Mandibular kinesiography (KNG)
研究概览
简要总结
Temporomandibular joint dysfunction (TMD) therapy remains an open challenge for modern dentistry. Usually physiotherapy is considered a reliable approach to treatment of TMD patients. Moreover, neuromuscular bites (orthotic) are able to reduce signs and symptoms of TMD. To our knowledge, no specific trials have been designed for the evaluation of the efficiency of physiotherapy vs neuromuscular bites in TMD patients.
The aim of this trial is to evaluate the efficiency in term of cranial muscles electromyography (sEMG), mandibular kinetic (KNG) and subjective pain scores, of orthotic vs manual physiotherapy therapy compared to placebo.
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 (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •myogenous TMD;
- •pain duration longer than 3 months;
- •presence of complete permanent dentition, with the possible exception of the third molars;
- •normal occlusion.
排除标准
- •Patients were excluded from the study if they met one or more of the following criteria:
- •presence of systemic or metabolic diseases;
- •eye diseases or visual defects;
- •history of local or general trauma;
- •neurological or psychiatric disorders;
- •muscular diseases;
- •cervical pain;
- •bruxism, as diagnosed by the presence of parafunctional facets and/or anamnesis of parafunctional tooth clenching and/or grinding;
- •pregnancy;
- •assumed use of anti-inflammatory, analgesic, anti-depressant, opioid, or myorelaxant - - drugs;
- •fixed or removable prostheses;
- •fixed restorations that affected the occlusal surfaces;
- •and either previous or concurrent orthodontic or orthognathic treatment. For comparison with previous literature, the diagnosis of myofascial-type TMD was provided after clinical examination by a trained clinician according to group 1a and 1b of the Research Diagnostic Criteria for TMD (RDC/TMD), in a blinded manner
结局指标
主要结局
Mandibular kinesiography (KNG)
时间窗: Average of 1 year
Evaluation of mandibular kinetics (expressed in millimeters/seconds)
Surface electromiography of cranial muscles (sEMG)
时间窗: Average of 1 year
Evaluation of surface electromiography of cranial muscles (expressed in microvolts)
次要结局
- Pain scale(15 days)
研究者
Davide Pietropaoli
PI
University of L'Aquila