Temporary Hydrostatic Splint Therapy and Its Effects on Occlusal Forces
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Change of percentage force distribution per sector.
研究概览
简要总结
The goal of this non-randomized controlled trial is to analyze and compare occlusal force distribution patterns using T-Scan III before and after hydrostatic splint therapy on both healthy subjects and subjects with temporomandibular disorders. The main questions it aims to answer are:
- Do occlusal forces for individual teeth differ before and after hydrostatic splint therapy?
- Does the percentage distribution of forces across different sectors differ before and after hydrostatic splint therapy?
Participants will:
- Perform occlusal analysis using the T-Scan III device;
- Use a hydrostatic splint for 30 minutes;
- Perform a second occlusal analysis after using the hydrostatic splint.
Researchers will compare healthy subjects and subjects with temporomandibular disorders to see if hydrostatic splint therapy makes a difference in the distribution patterns of occlusal forces.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy subjects with Angle Class I and a normal line of occlusion without malpositioned or rotated teeth;
- •complete permanent dentition except for the third molars;
- •no fixed prosthesis;
- •no dental caries;
- •no restorations on the occlusal surfaces of molars and premolars extending more than one-third of the surface;
- •no restorations on incisal edge;
- •no tenderness on percussion of any teeth;
- •no history of previous endodontic and orthodontic treatment,
- •extensive maxillofacial surgery;
- •no systematic neurological disorders.
排除标准
- •presence of orofacial pain that limits mouth opening;
- •malocclusion (e.g., open bite, increased overjet or reverse overjet, cross bite);
- •skeletal anomalies with occlusal disturbance.
研究组 & 干预措施
Control group - non-temporomandibular disorders group.
Patients diagnosed with no temporomandibular disorders.
干预措施: T-Scan occlusal recording No. I (Diagnostic Test)
Control group - non-temporomandibular disorders group.
Patients diagnosed with no temporomandibular disorders.
干预措施: Usage of the hydrostatic appliance (Device)
Control group - non-temporomandibular disorders group.
Patients diagnosed with no temporomandibular disorders.
干预措施: T-Scan occlusal recording No. II (Diagnostic Test)
Test group - temporomandibular disorders group
Patients diagnosed with mild, moderate, or severe temporomandibular disorders.
干预措施: T-Scan occlusal recording No. I (Diagnostic Test)
Test group - temporomandibular disorders group
Patients diagnosed with mild, moderate, or severe temporomandibular disorders.
干预措施: Usage of the hydrostatic appliance (Device)
Test group - temporomandibular disorders group
Patients diagnosed with mild, moderate, or severe temporomandibular disorders.
干预措施: T-Scan occlusal recording No. II (Diagnostic Test)
结局指标
主要结局
Change of percentage force distribution per sector.
时间窗: Change of percentage force distribution per sector at 30-minute of hydrostatic appliance usage.
Change of percentage force distribution for single dental elements.
时间窗: Change of percentage force distribution for single dental elements at 30-minute of hydrostatic appliance usage.
次要结局
未报告次要终点
研究者
Gediminas Žekonis
Professor
Lithuanian University of Health Sciences