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NCT Number: NCT07115797

ARS vs ARS With Arthrocentesis and PRP Injection in DDWR

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

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

arthrocentesis - PRP injection -ARS

Other

oarthrocentesis then PRP injection and then ARS

ARS

Other

Insertion Of ARS Only

Primary outcomes

  1. Maximum pain-free interincisal opening measured in mm by caliper

    Time frame: from enrollment to the end of study at 6 months

Secondary outcomes

  1. Pain measured by VAS scale

    Time frame: from enrollment to the end of study at 6 months

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 11, 2025
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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