Evaluation Study of Retro Discal Tissue Injection Arthroscopically Versus Ultrasound Guide Injection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-13

Study Completion Date

2026-06-30

Brief Summary

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A comparative evaluation study of arthroscopic retrodiscal tissue injection versus ultrasound-guided injection in temporomandibular joint disorders aims to assess differences in pain relief, functional improvement, and clinical outcomes between an invasive and a minimally invasive delivery technique. Arthroscopic injection allows direct visualization of intra-articular structures, accurate targeting of the retrodiscal tissues, and simultaneous management of associated pathology such as synovitis or adhesions, which may enhance therapeutic outcomes in advanced internal derangement. In contrast, ultrasound-guided injection offers a less invasive, cost-effective, and outpatient-based approach with improved accuracy over blind techniques, making it suitable for early or moderate cases. While both methods are effective in reducing pain and improving mouth opening and jaw function, arthroscopic injection may provide superior results in patients requiring diagnostic confirmation and mechanical intervention, whereas ultrasound-guided injection offers comparable symptomatic improvement with lower procedural morbidity and resource utilization.

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Detailed Description

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Conditions

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Arthroscope

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Arthroscopic Retrodiscal Tissue Injection

Group Type EXPERIMENTAL

Arthroscopic retrodiscal tissue injection

Intervention Type PROCEDURE

Arthroscopic retrodiscal tissue injection

Ultrasound-Guided Retrodiscal Tissue Injection

Group Type ACTIVE_COMPARATOR

Ultrasound-guided retrodiscal tissue injection

Intervention Type PROCEDURE

Ultrasound-guided retrodiscal tissue injection

Interventions

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Arthroscopic retrodiscal tissue injection

Intervention Type PROCEDURE

Ultrasound-guided retrodiscal tissue injection

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Adults aged 18-60 years with symptomatic TMJ disorder/internal derangement (unilateral or bilateral)
* TMJ pain at rest and/or during function for ≥ 3 months
* Clinical diagnosis consistent with disc displacement with or without reduction (with or without MRI confirmation, if included in the protocol)
* Baseline pain intensity ≥ 4/10 on VAS or NRS
* Limitation of mouth opening or functional impairment (e.g., maximum mouth opening ≤ 35 mm or pain-related limitation)
* Failed or insufficient response to conservative therapy for ≥ 4-6 weeks (e.g., soft diet, NSAIDs, splint therapy, physiotherapy)
* Ability to provide informed consent and comply with scheduled follow-up visits

Exclusion Criteria

* Previous TMJ surgery (arthroscopy or arthrotomy) on the study side or TMJ injection within the last 3-6 months
* TMJ ankylosis, fracture, tumor, or active infection
* Primary inflammatory arthropathy (e.g., rheumatoid arthritis, gout, psoriatic arthritis) or systemic connective tissue disease affecting the TMJ
* Significant degenerative joint disease (advanced osteoarthritis) if the study focuses on internal derangement or soft tissue pathology
* Severe skeletal or dentofacial deformity requiring orthognathic surgery during the study period
* Pregnancy or lactation
* Bleeding disorders, platelet disorders, or anticoagulant therapy that cannot be safely managed (particularly relevant for PRP injections)
* Known allergy or contraindication to the planned injectate or local anesthetic
* Severe uncontrolled systemic disease (ASA III-IV) or inability to tolerate anesthesia or sedation (for arthroscopy arm)
* Active psychiatric or neurologic condition that may impair accurate pain reporting or follow-up compliance

Minimum Eligible Age

15 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes