Effect of Different Oral Splints on the Maximum Bite Force in TMD Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Maximum bite force in the incisal and molar zones
研究概览
简要总结
The goal of this clinical trial is to evaluate whether three different types of intraoral splints can increase maximal voluntary mandibular clenching force in adults diagnosed with myogenous temporomandibular disorders (TMD). The main questions it aims to answer are:
Do intraoral splints enhance maximal clenching force in patients with muscle-related TMD? Is there a difference in the effectiveness of the three splint designs in improving muscle strength? Researchers will compare the effects of each splint within the same participants to determine which one most effectively increases clenching force.
Participants will:
Undergo baseline assessment of maximal mandibular clenching force Use each intraoral splint for a 30-day period Complete follow-up assessments after each intervention phase
详细描述
This clinical trial aims to evaluate the effect of three different types of intraoral splints on maximal voluntary bite force in patients diagnosed with myogenous temporomandibular disorders (TMD). A total of 150 participants were recruited, consisting of 75 men and 75 women. Each gender group was evenly divided into three intervention arms:
25 participants received the Lucia Jig splint 25 participants received the Sved splint 25 participants received the Occlusal splint All participants were previously diagnosed with muscle-related TMD by a qualified clinician. Each participant served as their own control. Baseline measurements of maximum bite force were recorded prior to the intervention using a gnatodynamometer (Kratos, Brazil). Measurements were taken in two anatomical zones: the incisal zone and the molar zone.
For each zone, three consecutive bite force measurements were recorded, with a 5-minute rest interval between each trial. The average of the three measurements was calculated and used as the baseline value for each zone.
Participants were instructed to use their assigned intraoral splint nightly for a period of 30 days. After this period, they returned for a follow-up assessment. The same measurement protocol was repeated: three bite force recordings in both the incisal and molar zones, each separated by a 5-minute interval. The average of these three post-intervention values was calculated for comparison with the baseline.
This within-subject design allows for the evaluation of changes in bite force attributable to each splint type, and for comparison across the three splint designs. The study seeks to determine whether intraoral splints can enhance muscle strength in patients with myogenous TMD, and which design is most effective in doing so.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with muscular TMD
- •Not using ant
- •Non pregnant women.
- •Not under convulsive, chronic pain, antidepresive, antihypertensive, pharmacological treatments
- •Without systemic pathologies.
排除标准
- •Treatment for chronic pain, depression, hypertension, convulsion condition with or without medication.
- •Regular use of benzodiazepines.
- •Systemic pathologies
- •Pregnant women
研究组 & 干预措施
Lucia jig
Lucia jig splint
干预措施: intraoral devices (Device)
Sved splint
Sved splint
干预措施: intraoral devices (Device)
Occlusal splint
Occlusal splint
干预措施: intraoral devices (Device)
结局指标
主要结局
Maximum bite force in the incisal and molar zones
时间窗: From enrollment to 30 days after splint utilization
Each patient will be tested at the beginning of the clinical trial on the maximum bite force in the incisal zone, and after 30 days post splint utilization
次要结局
未报告次要终点
研究者
Nicolás Pinto Pardo
Nicolas Pinto-Pardo
Universidad Vina del Mar