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临床试验/NCT07115797
NCT07115797尚未招募不适用

Anterior Repositioning Splint With or Without Arthrocentesis and Platelet-rich Plasma Injection In TMD Patients With Anterior Disc Displacement With Reduction: A Randomized Controlled Clinical Trial

Cairo University0 个研究点目标入组 20 人开始时间: 2025年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
20
主要终点
Maximum pain-free interincisal opening measured in mm by caliper

研究概览

简要总结

This study will be conducted to assess the effect of anterior repositioning splint and arthrocentesis with platelet-rich plasma injection compared to anterior repositioning splint only, in TMD patients with anterior disc displacement with reduction

详细描述

Anterior repositioning splint (ARS) allows the mandible to assume an anterior position to centric occlusion, providing a more favorable condyle-disc relationship in the fossa so that normal function can be established. The goal is to eliminate the signs and symptoms associated with disc-interference disorders. Maintaining the mandible in a temporary therapeutic position in which click is eliminated and thereby allowing the disc to reposition

A study by (Mohamed & Abd el Azizi, 2021) Found that ARS showed a significant reduction of pain and increase in maximum mouth opening after 1 month and an increase in MMO. Platelet-rich plasma (PRP) is a therapeutic agent consisting essentially of a platelet concentrate and associated growth factors taken and centrifuged from a sample of the patient's blood. It was initially introduced in the fields of stomatology, maxillofacial/plastic surgery, and reconstructive surgery in the 1990s and its clinical use is due to its potential healing properties through cell recruitment, proliferation, differentiation, and consequently, tissue remodeling. It has been found to have several advantages over the use of corticosteroids in the treatment of TMJ degenerative and inflammatory conditions, the most remarkable being its lack of serious and/or irreversible adverse effects. Treatment with PRP injections has reported anti-inflammatory, analgesic and antibacterial properties and, at the same time, restores intra-articular levels of hyaluronic acid, increases glycosaminoglycan chondrocyte synthesis, balances joint angiogenesis, and induces stem cell migration.

Explanation for choice of comparators:

Anterior repositioning splint (ARS) therapy is a common conservative method for treating disc-displacement-related (TMDs). ARS can be fixed on the maxilla or mandible and it usually maintains the protrusion status through an anterior guidance ramp The protrusion of the mandible changes the disc condyle relationship and is widely used in intra-articular TMD treatment. This method can significantly improve pain symptoms. Thus, it can also be used in pain-related TMDs.

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 (Outcomes Assessor)

盲法说明

the observers will be blind to which group this case belongs. evaluators, and statisticians will be blinded.

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients suffering from internal derangement anterior disc displacement
  • Mouth Opening: Limited range of motion or difficulty with full mouth opening
  • Symptoms: Patients who report typical symptoms of TMJ dysfunction, such as pain, discomfort, or clicking sounds in the joint, especially when opening or closing the mouth.
  • Clicking: Audible clicking.
  • Pain: Pain or tenderness around the TMJ, often radiating to the ear, temple, or neck.

排除标准

  • Blood dyscrasias and Uncontrolled systemic diseases.
  • Rheumatoid Arthritis.
  • Infection in the pre-auricular area.

结局指标

主要结局

Maximum pain-free interincisal opening measured in mm by caliper

时间窗: from enrollment to the end of study at 6 months

次要结局

  • Pain measured by VAS scale(from enrollment to the end of study at 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Saleh Thabit Ali

Master's candidate

Cairo University

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