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Liquid Phase Concentrated Growth Factor Versus Conventional Arthrocentesis in Temporomandibular Disc Displacement (LPCGF in TMDs)

H

Horus University

Status

Not yet enrolling

Conditions

Internal Derangement of the Tempromandibular Joint
Temporomandibular Disorders (TMD)
Anterior Disc Displacement

Treatments

Procedure: Conventional arthrocentesis
Procedure: Liquid Phase Concentrated Growth Factor

Study type

Interventional

Funder types

Other

Identifiers

NCT07075276
CGF for management of TMDs

Details and patient eligibility

About

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.

Enrollment

32 estimated patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

32 participants in 2 patient groups

Group A
Experimental group
Description:
16 patients have anterior disc displacement with or without reduction will be treated with injection of liquid phase concentrated growth factor
Treatment:
Procedure: Liquid Phase Concentrated Growth Factor
Group B
Active Comparator group
Description:
16 patients have anterior disc displacement with or without reduction will be treated with conventional arthrocentesis
Treatment:
Procedure: Conventional arthrocentesis

Trial contacts and locations

1

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Central trial contact

Mohamed Ali Habib, Teaching assistant; Eman AbdElsalam Yousef, Associate professor

Data sourced from clinicaltrials.gov

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