跳至主要内容
临床试验/CTRI/2024/11/077090
CTRI/2024/11/077090
招募中
2/3 期

Development and design of novel prosthetic total temporomandibular joint (TMJ) reconstruction system in patients with temporomandibular joint disorder

Indian Council of Medical Research3 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年12月2日最近更新:

概览

阶段
2/3 期
状态
招募中
入组人数
30
试验地点
3
主要终点
A. Subjective Outcomes

概览

简要总结

Work on Temporomandibular Joint (TMJ) at tertiary care centers like Maulana Azad Institute of Dental Sciences, Delhi, is being carried out for multiple decades. However, these institutes still rely on autogenous grafts for the reconstruction of temporomandibular joint. This not only creates a second surgical site but also carries the risk of patient morbidity and graft resorption. Thus, an optimal treatment alternative is not available for these patients. Out of multiple options for reconstruction of the temporomandibular joint, prosthetic joint replacement is associated with a single surgery which causes less donor site morbidity. Commercially available pre-fabricated TMJ prosthesis does not fit the Indian population as they have been designed according to the Caucasian population, it cannot fit the patient population in India. The alternative to this is custom -made patient specific TMJ prosthesis which is designed according to the patient anatomy. Patient specific TMJ prosthesis is not available commercially in India, and it is not cost effective around the world (average price around 20,000 USD). Due to absence of complete range of motion with stock prosthetic TMJ, the mouth opening remains less. Inability to open the mouth is an impediment to patient to eat, speak.

Prosthetic joints available in the market also do not have any arrangement to incorporate lateral pterygoid muscle which is required for proper mouth opening without jaw deviation and performing lateral movements of the TMJ. In view of the above problems an innovative design was created by the investigators that would facilitate translation as well as rotational movements with a slot to incorporate the lateral pterygoid muscles. To achieve these objectives, the investigators comprehensively planned the reconstruction of glenoid fossa and reattachment of the lateral pterygoid muscle to the prosthetic TMJ to support normal functional occlusion and mandibular motion. The innovative design of prosthesis is based on the biomechanics of the natural temporomandibular joint and is focused on 4 main outcomes: Maximum mouth opening and lateral movements, pain reduction, dietary restitution, and quality-of-life improvement. As a result, the results from this project would help to outline that re-establishing functional and structural mechanics is a critical goal and influences total TMJ replacement surgical success. The modification in the design of the prosthesis aims to improve the clinical success of total joint prosthesis in restoring mouth opening and complete range of mandibular movements. During total joint replacement, the proper reattachment of the lateral pterygoid on condylar neck of the mandibular component is necessary for the proper grinding of food. Similarly, the change in glenoid fossa design will influence the range of mandibular movements which may directly influence the vital functions of speech, mastication and overall quality of life.

研究设计

研究类型
Interventional
分配方式
Na
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • a) End-Stage Temporomandibular disorders including Internal disc derangement and osteoarthritis b) Late-stage degenerative joint disease (osteoarthritis, rheumatoid arthritis, traumatic arthritis, etc.) c) Ankylosis irrespective of site and duration of ankylosis d) Revision procedures for failed alloplastic or autogenous reconstruction f) Neoplasia/cyst requiring resection of TMJ.

排除标准

  • a) Allergy to any of the prosthetic materials b) Systemic disease with increased susceptibility to infection c) Known neurologic/psychiatric disorders, d) Uncontrolled systemic disorder or immunocompromised state, e) Patient not willing to participate in study f) Skeletally immature patients g) Bilateral ankylosis cases / bilateral temporomandibular joint disorders.

结局指标

主要结局

A. Subjective Outcomes

时间窗: The outcomes will be assessed/estimated Preoperatively(baseline), at 1-month, 3-months and 6-months follow-up

1)Improvement in pain levels

时间窗: The outcomes will be assessed/estimated Preoperatively(baseline), at 1-month, 3-months and 6-months follow-up

2. Improvement in diet and jaw function

时间窗: The outcomes will be assessed/estimated Preoperatively(baseline), at 1-month, 3-months and 6-months follow-up

B. Objective Outcomes

时间窗: The outcomes will be assessed/estimated Preoperatively(baseline), at 1-month, 3-months and 6-months follow-up

1. Changes in range of motion of mandible

时间窗: The outcomes will be assessed/estimated Preoperatively(baseline), at 1-month, 3-months and 6-months follow-up

2. Changes in Occlusion

时间窗: The outcomes will be assessed/estimated Preoperatively(baseline), at 1-month, 3-months and 6-months follow-up

3. Changes in Mandibular deviation

时间窗: The outcomes will be assessed/estimated Preoperatively(baseline), at 1-month, 3-months and 6-months follow-up

4. Electromyography

时间窗: The outcomes will be assessed/estimated Preoperatively(baseline), at 1-month, 3-months and 6-months follow-up

5. Bite force

时间窗: The outcomes will be assessed/estimated Preoperatively(baseline), at 1-month, 3-months and 6-months follow-up

6. Total Time of surgical procedure

时间窗: The outcomes will be assessed/estimated Preoperatively(baseline), at 1-month, 3-months and 6-months follow-up

7. Facial nerve function

时间窗: The outcomes will be assessed/estimated Preoperatively(baseline), at 1-month, 3-months and 6-months follow-up

8. Other complications of surgical procedure

时间窗: The outcomes will be assessed/estimated Preoperatively(baseline), at 1-month, 3-months and 6-months follow-up

C. Quality of life

时间窗: The outcomes will be assessed/estimated Preoperatively(baseline), at 1-month, 3-months and 6-months follow-up

D. Changes in Joint morphology

时间窗: The outcomes will be assessed/estimated Preoperatively(baseline), at 1-month, 3-months and 6-months follow-up

次要结局

  • Develop and design a novel total temporomandibular joint (TMJ) reconstruction system in a cohort of patients treated for Temporomandibular joint disorders (TMJ) suitable for Indian population.(3 years)

研究者

申办方类型
Government funding agency
责任方
Principal Investigator
主要研究者

Sujata Mohanty

Maulana Azad Institute of Dental Sciences

研究点 (3)

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