The Effectiveness of Different Therapeutic Jaw Position Determining Methods in Repositioning Splint Therapy for Temporomandibular Joint Disk Displacement Without Reduction：A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Condylar position as assessed by CBCT measurements
研究概览
简要总结
The goal of this clinical trial is to learn if different therapeutic jaw position determining methods influence the efficacy of repositioning splint therapy for temporomandibular joint disk displacement without reduction. The main questions it aims to answer are:
Does different therapeutic jaw position determining methods influence the efficacy of repositioning splint therapy for temporomandibular joint disk displacement without reduction? Researchers will compare the efficacy of repositioning splint therapy made with different therapeutic jaw position determining methods for temporomandibular joint disk displacement without reduction.
Participants will:
Take repositioning splint made with different therapeutic jaw position determining methods every day for 3-6 months.
Visit the clinic once every 3 weeks for checkups and tests.
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, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 13 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 13-50 years, with permanent dentition, possessing full autonomy in behavior and expression;
- •Meeting the 2014 Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) diagnostic standards for irreducible temporomandibular joint disc displacement;
- •MRI-confirmed unilateral irreducible disc displacement: At maximum intercuspation: Posterior band of disc located anterior to the 11:30 position, intermediate zone anterior to condyle; At maximum mouth opening: Intermediate zone remains anterior to condyle.
排除标准
- •Systemic diseases, psychiatric disorders, or impaired consciousness;
- •Pain-only disorders without articular pathology signs;
- •Mandibular hypoplasia, TMJ tumors, or prior TMJ trauma;
- •History of definitive TMJ disorder treatment.
研究组 & 干预措施
receive repositioning splint therapy with jaw position determined by mechanical articulator
Participants will receive repositioning splint therapy with jaw position determined by mechanical articulator method for 3-6 months.
干预措施: Repositioning splint therapy with jaw position determined by mechanical articulator (Procedure)
receive repositioning splint therapy with jaw position determined by ai-assisted virtual articulator
Participants will receive repositioning splint therapy with jaw position determined by ai-assisted virtual articulator.
干预措施: Repositioning splint therapy with jaw position determined by ai-assisted virtual articulator (Procedure)
receive repositioning splint therapy with jaw position determined by ai-assisted virtual patient
Participants will receive repositioning splint therapy with jaw position determined by ai-assisted virtual patient
干预措施: Repositioning splint therapy with jaw position determined by ai-assisted virtual patient (Procedure)
结局指标
主要结局
Condylar position as assessed by CBCT measurements
时间窗: 3-6 months
Condylar position of the three groups will be assessed after each treatment based on the measurements of sagittal joint spaces (anterior/superior/posterior) on CBCT's cross-sectional views.
Condylar repositioning rate as assessed by CBCT measurements
时间窗: 3-6 months
Using Mimics software, post-treatment condylar positions were analyzed and measured. The proportions of affected-side condyles reposition to the Gelb 4/7 position were compared across the three therapeutic jaw position determination methods.
次要结局
- Fricton index as assessed by comprehensive physical examination to participants(3-6 months)
- Dysfunction index as assessed by by comprehensive physical examination to participants(3-6 months)
- Palpation index as assessed by by comprehensive physical examination to participants(3-6 months)
研究者
Hao Yu
Director; Clinical Professor; dean of overseas education college; vice dean of school and hospital of stomatology
Fujian Medical University