Liquid Phase Concentrated Growth Factor Versus Conventional Arthrocentesis in Temporomandibular Disc Displacement

Not Applicable

Not yet recruiting

• Conditions: Temporomandibular Disorders (TMD); Internal Derangement of the Tempromandibular Joint; Anterior Disc Displacement

• Registration Number: NCT07075276
• Lead Sponsor: Horus University

Brief Summary

This study aims to rigorously assess the effectiveness of LPCGF in the management of internal disc displacement in patients with TMD through a randomized clinical trial. By comparing LPCGF therapy with conventional arthrocentesis, this research looks to provide robust evidence on the efficacy, safety, and potential role of (LPCGF) as an alternative therapeutic choice for IDD.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-11
• Study First Submitted QC: 2025-07-11
• Last Update Submitted: 2025-07-11
• Study First Posted: 2025-07-20
• Last Update Posted: 2025-07-20
• Study Start: 2025-08-01
• Primary Completion: 2026-03-01
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• 1. Adults aged 18-45 years. 2. Patients scored as (ASA I).9 3. Presence of complete or nearly complete set of natural dentition with Angle class I occlusion. 4. Diagnosed with unilateral involvement of disc displacement, according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD).10 5. Symptoms include one or more of the following: pain, joint sounds, and limited mandibular movement (Maximum Mouth Opening< 40mm) 6. No prior surgical intervention for TMD. 7. Patient's willingness to participate and follow the study protocol.

Exclusion Criteria

• 1. TMJ pathology related to mechanical deformities 2. Psychiatric problems or presence of systemic diseases that may affect healing (e.g., uncontrolled diabetes, autoimmune disorders, hematologic or neurologic disorders, inflammatory or connective tissue disorders as well as rheumatological or previous infectious diseases, head and neck cancer). 3. Patient unwilling or has contraindication to MRI 4. Previous injections or surgical interventions of the TMJ. 5. Concurrent use of anticoagulants or anti-inflammatory medications within the last 30 days. 6. Pregnant or breastfeeding women. 7. History of trauma or infection in the TMJ region. 8. Allergy to local anesthetics or other components used in the study. 9. Patients diagnosed with (Disc Displacement with reduction with no pain or limited mandibular movements).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Assess and comparing the pain of both groups	Assessed at baseline (before treatment),1week, 1 month, 3 months, and 6 months after the intervention.	measured using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst pain)
Assess and comparing the mouth opening of both groups	Assessed at baseline (before treatment),1week, 1 month, 3 months, and 6 months after the intervention.	measured in millimeters (Maximum inter-incisal opening measured by the distance in millimeters between the incisal edges of the upper and lower central incisors in vertical direction at maximum pain free mouth opening) by using caliper. and comparing the results of both groups

Secondary Outcome Measures

Name	Time	Method
Joint sounds	Assessed at baseline (before treatment),1week, 1 month, 3 months, and 6 months after the intervention.	(clicking and crepitus) evaluated by clinical examination; presence of joint noise at opening and closing was evaluated by light bilateral digital palpation during jaw movement.
Mandibular deviation during mouth opening.	Assessed at baseline (before treatment),1week, 1 month, 3 months, and 6 months after the intervention.	By clinical examination , observe mandibular deviation toward right or left side or deflection during opening and closing the mouth
Lateral and protrusive movements	Assessed at baseline (before treatment),1week, 1 month, 3 months, and 6 months after the intervention	(Range of lateral and protrusive movements measured by the distance in millimeters between the upper and lower midlines in horizontal direction on lateral and protrusive movements by using caliper).
tenderness on palpation	Assessed at baseline (before treatment),1week, 1 month, 3 months, and 6 months after the intervention.	Presence or absence of joint tenderness on palpation: recorded as tender or not tender.
TMD symptoms	Assessed at baseline (before treatment),1week, 1 month, 3 months, and 6 months after the intervention.	TMD symptoms were evaluated using Modified Helkimo Index

Trial Locations

Locations (1)

Faculty of Dentistry- Horus University in Egypt; 🇪🇬 Damietta, New Damietta, Egypt