Recruiting NCT07075276
Liquid Phase Concentrated Growth Factor Versus Conventional Arthrocentesis in Temporomandibular Disc Displacement
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Liquid Phase Concentrated Growth Factor, Conventional arthrocentesis.
- Who it may be relevant to
- Registry conditions: Temporomandibular Disorders (TMD), Internal Derangement of the Tempromandibular Joint, Anterior Disc Displacement. Basic parameters: 18 years — 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Injection of Liquid Phase Concentrated Growth Factor Versus Conventional Arthrocentesis in Management of Temporomandibular Disc Displacement: A Randomized Controlled Clinical Trial
Overview
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.
Interventions
- Procedure 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 - Procedure Conventional arthrocentesis
16 patients with anterior disc displacement with or without reduction randomly allocated to be treated with conventional arthrocentesis
Primary outcome measures
- 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.]
- 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.]
Secondary outcome measures (5)
- Joint sounds [Time frame: Assessed at baseline (before treatment),1week, 1 month, 3 months, and 6 months after the intervention.]
- Mandibular deviation during mouth opening. [Time frame: Assessed at baseline (before treatment),1week, 1 month, 3 months, and 6 months after the intervention.]
- Lateral and protrusive movements [Time frame: Assessed at baseline (before treatment),1week, 1 month, 3 months, and 6 months after the intervention]
- tenderness on palpation [Time frame: Assessed at baseline (before treatment),1week, 1 month, 3 months, and 6 months after the intervention.]
- TMD symptoms [Time frame: Assessed at baseline (before treatment),1week, 1 month, 3 months, and 6 months after the intervention.]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Faculty of Dentistry- Horus University in Egypt — Damietta
Identifiers
NCT: NCT07075276 · CGF for management of TMDs