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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Liquid Phase Concentrated Growth Factor
Procedure/Surgery16 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/Surgery16 patients with anterior disc displacement with or without reduction randomly allocated to be treated with conventional arthrocentesis
Treatment groups
Trial outcomes
Primary outcomes
Assess and comparing the pain of both groups
measured using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst pain)
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
Secondary outcomes
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.
Mandibular deviation during mouth opening.
By clinical examination , observe mandibular deviation toward right or left side or deflection during opening and closing the mouth
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).
tenderness on palpation
Presence or absence of joint tenderness on palpation: recorded as tender or not tender.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.