Basis for an Etiological Diagnosis and Treatment of the Chronic TMD-pain: RCT Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 4
- 主要终点
- Visual Analogic Scale for Pain Intensity (0-10)
研究概览
简要总结
The purpose of this study is to determine whether occlusal adjustment by selective grinding and/or occlusal addition is an effective treatment of chronic temporomandibular joint disorders.
详细描述
Temporomandibular disorders (TMD) are very common disorders in daily dentistry and oral and maxillofacial practice. The key symptoms are jaw joint pain and limited mouth opening. Other than trauma, the causes remain unknown; consequently, there are no treatments based on specific etiologies. In our experience, patients can usually receive beneficial occlusal adjustments if these are carefully planned and performed in two steps: (1) elimination of premature contacts, which reduces loads in the temporomandibular joints, and (2) individualized remodeling of lateral anterior guidance to facilitate unilateral alternate chewing. The study will use stratified blocking randomization to blindly assign patients to the real or placebo treatment groups in order to evaluate the null hypothesis (H0) that "Occlusal adjustment of sufficient quality has no effect on chronic pain and/or limited mouth opening in TMD patients."
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 (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •People suitable for inclusion in the study are full dentate patients
- •Aged between 18 and 65 years
- •Patients with chronic TMD pain (and usually with associated limited mouth opening) for whom occlusal adjustment could achieve normal occlusion, both static and functionally equilibrated
排除标准
- •Pregnancy
- •Previous TMJ surgery
- •Patient refusal to consent to participate in the study or significant concerns about the study
- •Limited collaboration
- •Concurrent active treatment with orthodontics, and active periodontal disease
结局指标
主要结局
Visual Analogic Scale for Pain Intensity (0-10)
时间窗: Baseline, immediately after therapy, 3 months and 6 months after therapy
The primary outcome was self-reported pain intensity on a 0 to 10 cm visual analog scale considering the temporomandibular disorder side, being 0="No pain" and 10="Worst imaginable pain"
次要结局
- Symptom Checklist-90-Revised (SCL-90-R®)(Before and 6 months after therapy)
- Preferred Chewing Side(Before and 6 months after therapy)
- Maximum Mouth Opening (mm)(6 months (before and after therapy) including 4 assessment points: pre-treatment, post-treatment, 3- and 6-month follow up)
- Condylar Path Angles(Baseline)
研究者
Urbano Santana
Prof.
University of Santiago de Compostela