Effect of Injectable Platelet-rich Fibrin on Disc Displacement Without Reduction

Study Overview
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Brief Summary
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This randomized clinical study was conducted on patients with disc displacement without reduction. Patient was selected one of the two study groups: control group received only arthrocentesis or test group received arthrocentesis + injectable platelet-rich fibrin (i-PRF). As primary outcome variable, pain was recorded at preoperatively and at postoperatively 1, 2, 3, 6 and 12 months. Maximum mouth opening, lateral and protrusive movements were formed as secondary outcome variables.

Detailed Description
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This randomized clinical study was conducted on patients with disc displacement without reduction. Patient was selected one of the two study groups: control group received only arthrocentesis or test group received arthrocentesis + i-PRF. Arthrocentesis procedure was performed for all groups with two needle technique. For test group, intra-articular i-PRF was made. As a primary outcome variable, pain was recorded at preoperatively and at postoperatively 1, 2, 3, 6 and 12 months. Maximum mouth opening, lateral and protrusive movements were formed as secondary outcome variables.

Official Title
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Effect of Intra-articular Injection of Injectable Platelet-rich Fibrin on Disc Displacement Without Reduction

Conditions
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Disc Disorder

Intervention / Treatment
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* Procedure: i-PRF
* Procedure: Arthrocentesis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: unilateral or bilateral disc displacement without reduction localized pain on temporomandibular joint decreased mouth opening, lateral and protrusive movements Exclusion Criteria: Malignant or inflammatory disorders prior surgical history of temporomandibular joint

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test group<br>intra-articular i-PRF injection after arthrocentesis | Procedure: i-PRF<br>* Arthrocentesis performed with two-needle technique, and then injection of i-PRF intra-articularly<br>|
| Experimental: Control group<br>only arthrocentesis | Procedure: Arthrocentesis<br>* Arthrocentesis performed with two-needle technique<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of pain | Pain was measured with a 10-point visual analogue scale which range from 0 meaning no pain to 10 meaning worst pain at preoperatively and at 1, 2, 3, 6 and 12 months postoperatively | at preoperatively, and at 1, 2, 3, 6 and 12 months postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of maximum mouth opening | Maximum mouth opening was measured with a millimeter ruler at preoperatively and at 1, 2, 3, 6 and 12 months postoperatively | at preoperatively, and at 1, 2, 3, 6 and 12 months postoperatively | 
| Change of lateral movements | Lateral movements were measured with a millimeter ruler at preoperatively and at 1, 2, 3, 6 and 12 months postoperatively | at preoperatively, and at 1, 2, 3, 6 and 12 months postoperatively | 
| Change of protrusive movements | Protrusive movements were measured with a millimeter ruler at preoperatively and at 1, 2, 3, 6 and 12 months postoperatively | at preoperatively, and at 1, 2, 3, 6 and 12 months postoperatively |