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

NCT ID: NCT07075276

Last Updated: 2025-09-09

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

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-15

Study Completion Date

2026-08-01

Brief Summary

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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

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group A

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

Group Type EXPERIMENTAL

Liquid Phase Concentrated Growth Factor

Intervention Type 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 B

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

Group Type ACTIVE_COMPARATOR

Conventional arthrocentesis

Intervention Type PROCEDURE

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

Interventions

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Liquid Phase Concentrated Growth Factor

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

Intervention Type PROCEDURE

Conventional arthrocentesis

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

Intervention Type PROCEDURE

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Horus University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Ali Habib

Teaching assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohamed Ali Habib, Teaching Assistant

Role: PRINCIPAL_INVESTIGATOR

Horus University in Egypt - Faculty of dentistry

Eman AbdElsalam Yousef, Ass. prof

Role: STUDY_DIRECTOR

Horus University in Egypt- Faculty of dentistry

Ahmed Khalil, lecturer

Role: STUDY_DIRECTOR

Horus University in Egypt - Faculty of dentistry

Locations

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Faculty of Dentistry- Horus University in Egypt

Damietta, New Damietta, Egypt

Site Status

Countries

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Egypt

Central Contacts

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Mohamed Ali Habib, Teaching assistant

Role: CONTACT

+2001069505336

Eman AbdElsalam Yousef, Associate professor

Role: CONTACT

+20 15 56767533

Facility Contacts

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Mohamed Ali Habib, Teaching Assistant

Role: primary

+201069505336

Other Identifiers

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CGF for management of TMDs

Identifier Type: -

Identifier Source: org_study_id

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