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NCT Number: NCT07075276

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

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.

Recruiting

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry- Horus University in Egypt

Damietta, New Damietta, 34518, Egypt

Location status: Recruiting

Location contact

Mohamed Ali Habib, Teaching Assistant

CONTACT

[email protected]

+201069505336

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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

Conventional arthrocentesis

Procedure

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

Primary outcomes

  1. Assess and comparing the pain of both groups

    Time frame: 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)

  2. Assess and comparing the mouth opening of both groups

    Time frame: 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 outcomes

  1. Joint sounds

    Time frame: 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.

  2. Mandibular deviation during mouth opening.

    Time frame: 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

  3. Lateral and protrusive movements

    Time frame: 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).

  4. tenderness on palpation

    Time frame: 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.

  5. TMD symptoms

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

    TMD symptoms were evaluated using Modified Helkimo Index

Study contacts

Contact information is provided by the study sponsor or research team.

Eman AbdElsalam Yousef, Associate professor

CONTACT

[email protected]

+20 15 56767533

Mohamed Ali Habib, Teaching assistant

CONTACT

[email protected]

+2001069505336

Sponsors and collaborators

Lead sponsor

Horus University

Other

Registry information

Official study title

Injection of Liquid Phase Concentrated Growth Factor Versus Conventional Arthrocentesis in Management of Temporomandibular Disc Displacement: A Randomized Controlled Clinical Trial

Acronym: LPCGF in TMDs

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 20, 2025
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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