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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorHorus University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Liquid Phase Concentrated Growth Factor

    Procedure/Surgery

    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/Surgery

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

Treatment groups

32 Participants
are divided into 2 treatment groups
Group A: Group AExperimental treatment 1 intervention
Group B: Group BActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Assess and comparing the pain of both groups

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

Time frame
Assessed at baseline (before treatment),1week, 1 month, 3 months, and 6 months after the intervention.
2

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

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

Secondary outcomes

1

Joint sounds

(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.

Time frame
Assessed at baseline (before treatment),1week, 1 month, 3 months, and 6 months after the intervention.
2

Mandibular deviation during mouth opening.

By clinical examination , observe mandibular deviation toward right or left side or deflection during opening and closing the mouth

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

Lateral and protrusive movements

(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).

Time frame
Assessed at baseline (before treatment),1week, 1 month, 3 months, and 6 months after the intervention
4

tenderness on palpation

Presence or absence of joint tenderness on palpation: recorded as tender or not tender.

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

Other outcomes

Sponsors and contacts

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