ARS vs ARS With Arthrocentesis and PRP Injection in DDWR

NCT ID: NCT07115797

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2026-10-31

Brief Summary

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

Detailed Description

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.

Conditions

TMJ Disc Displacement With Reduction; TMD; PRP Injection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Comparator

ARS

Group Type: ACTIVE_COMPARATOR

ARS

Intervention Type: OTHER

Insertion Of ARS Only

intervention

arthrocentesis then PRP injection and then ARS

Group Type: ACTIVE_COMPARATOR

arthrocentesis - PRP injection -ARS

Intervention Type: OTHER

oarthrocentesis then PRP injection and then ARS

Interventions

arthrocentesis - PRP injection -ARS

oarthrocentesis then PRP injection and then ARS

Intervention Type: OTHER

ARS

Insertion Of ARS Only

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Saleh Thabit Ali

Master's candidate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

ARS+- PRP & Arthrocentesis

Identifier Type: -

Identifier Source: org_study_id