Anterior Disc Displacement, Internal Derangement of the Tempromandibular Joint, Temporomandibular Disorders (TMD)
Conditions
Keywords
Temporomandibular disorder, Concentrated growth factor, Anterior disc displacement with reduction, Anterior disc displacement without reduction, Arthrocentesis
Brief summary
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
PROCEDURELiquid 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
PROCEDUREConventional arthrocentesis
16 patients with anterior disc displacement with or without reduction randomly allocated to be treated with conventional arthrocentesis
Sponsors
Horus University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess and comparing the pain of both groups | 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) |
| Assess and comparing the mouth opening of both groups | 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
| Measure | Time frame | Description |
|---|---|---|
| Joint sounds | 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. |
| Mandibular deviation during mouth opening. | 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 |
| Lateral and protrusive movements | 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). |
| tenderness on palpation | 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. |
| TMD symptoms | Assessed at baseline (before treatment),1week, 1 month, 3 months, and 6 months after the intervention. | TMD symptoms were evaluated using Modified Helkimo Index |
Countries
Egypt
Contacts
CONTACTMohamed Ali Habib, Teaching assistant
CONTACTEman AbdElsalam Yousef, Associate professor
PRINCIPAL_INVESTIGATORMohamed Ali Habib, Teaching Assistant
Horus University in Egypt - Faculty of dentistry
STUDY_DIRECTOREman AbdElsalam Yousef, Ass. prof
Horus University in Egypt- Faculty of dentistry
STUDY_DIRECTORAhmed Khalil, lecturer
Horus University in Egypt - Faculty of dentistry
Outcome results
None listed