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Not yet recruiting NCT07115797

ARS vs ARS With Arthrocentesis and PRP Injection in DDWR

No phase Interventional TMJ Disc Displacement With Reduction TMD PRP Injection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: arthrocentesis - PRP injection -ARS, ARS.
Who it may be relevant to
Registry conditions: TMJ Disc Displacement With Reduction, TMD, PRP Injection. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official 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

Overview

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.

Interventions

  • Other arthrocentesis - PRP injection -ARS
    oarthrocentesis then PRP injection and then ARS
  • Other ARS
    Insertion Of ARS Only

Primary outcome measures

  • Maximum pain-free interincisal opening measured in mm by caliper [Time frame: from enrollment to the end of study at 6 months]
Secondary outcome measures (1)
  • Pain measured by VAS scale [Time frame: from enrollment to the end of study at 6 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07115797 · ARS+- PRP & Arthrocentesis

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗