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Clinical Trials/NCT05640206
NCT05640206
Completed
Not Applicable

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

Ege University1 site in 1 country80 target enrollmentOctober 1, 2019
ConditionsDisc Disorder

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Disc Disorder
Sponsor
Ege University
Enrollment
80
Locations
1
Primary Endpoint
Change of pain
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2019
End Date
July 1, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Gözde Işık

Assistan Professor

Ege University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change of pain

Time Frame: at preoperatively, and at 1, 2, 3, 6 and 12 months postoperatively

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

Secondary Outcomes

  • Change of maximum mouth opening(at preoperatively, and at 1, 2, 3, 6 and 12 months postoperatively)
  • Change of lateral movements(at preoperatively, and at 1, 2, 3, 6 and 12 months postoperatively)
  • Change of protrusive movements(at preoperatively, and at 1, 2, 3, 6 and 12 months postoperatively)

Study Sites (1)

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