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

NCT07075276 | Recruiting DMC

• 1 other identifier: CGF for management of TMDs
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Temporomandibular disorder; Concentrated growth factor; Anterior disc displacement with reduction; Anterior disc displacement without reduction; Arthrocentesis

Outcome Measures

Primary Outcomes (2)

• Assess and comparing the pain of both groups

  measured using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst pain)

  Assessed at baseline (before treatment),1week, 1 month, 3 months, and 6 months after the intervention.

• Assess and comparing the mouth opening of both groups

  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

  Assessed at baseline (before treatment),1week, 1 month, 3 months, and 6 months after the intervention.

Secondary Outcomes (5)

• Joint sounds

  Assessed at baseline (before treatment),1week, 1 month, 3 months, and 6 months after the intervention.

• Mandibular deviation during mouth opening.

  Assessed at baseline (before treatment),1week, 1 month, 3 months, and 6 months after the intervention.

• Lateral and protrusive movements

  Assessed at baseline (before treatment),1week, 1 month, 3 months, and 6 months after the intervention

• tenderness on palpation

  Assessed at baseline (before treatment),1week, 1 month, 3 months, and 6 months after the intervention.

• TMD symptoms

  Assessed at baseline (before treatment),1week, 1 month, 3 months, and 6 months after the intervention.

Study Arms (2)

Group A

EXPERIMENTAL

16 patients have anterior disc displacement with or without reduction will be treated with injection of liquid phase concentrated growth factor

Procedure: Liquid Phase Concentrated Growth Factor

Group B

ACTIVE COMPARATOR

16 patients have anterior disc displacement with or without reduction will be treated with conventional arthrocentesis

Procedure: Conventional arthrocentesis

Interventions

Liquid Phase Concentrated Growth Factor PROCEDURE

16 patients with anterior disc displacement with or without reduction randomly allocated to be treated with injection of liquid phase concentrated growth factor

Group A

Conventional arthrocentesis PROCEDURE

16 patients with anterior disc displacement with or without reduction randomly allocated to be treated with conventional arthrocentesis

Group B

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. 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.

You may not qualify if:

• \. 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).

Sponsors & Collaborators

• Horus University: lead

Study Sites (1)

Faculty of Dentistry- Horus University in Egypt

Damietta, New Damietta, 34518, Egypt

RECRUITING

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Study Officials

• Mohamed Ali Habib, Teaching Assistant

  Horus University in Egypt - Faculty of dentistry

  PRINCIPAL INVESTIGATOR

• Eman AbdElsalam Yousef, Ass. prof

  Horus University in Egypt- Faculty of dentistry

  STUDY DIRECTOR

• Ahmed Khalil, lecturer

  Horus University in Egypt - Faculty of dentistry

  STUDY DIRECTOR

Central Study Contacts

Mohamed Ali Habib, Teaching assistant

CONTACT

+2001069505336; mbasiouny@horus.edu.eg

Eman AbdElsalam Yousef, Associate professor

CONTACT

+20 15 56767533; eabdelsalam@horus.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching assistant

Model Details: 16 patients with anterior disc displacement with or without reduction will be treated with liquid phase concentrated growth factor and 16 patients will be treated with conventional arthrocentesis

Study Record Dates

• First Submitted: July 11, 2025
• First Posted: July 20, 2025
• Study Start: October 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)