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

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

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.

Study Overview

• Status: Completed
• Conditions: Disc Disorder
• Intervention / Treatment: Procedure: i-PRF; Procedure: Arthrocentesis

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Bornova
    • İzmir, Bornova, Turkey, 35100
      • Ege University Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ege University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): July 1, 2021
• Study Completion (Actual): July 1, 2021

Study Registration Dates

• First Submitted: November 29, 2022
• First Submitted That Met QC Criteria: November 29, 2022
• First Posted (Actual): December 7, 2022

Study Record Updates

• Last Update Posted (Estimate): December 8, 2022
• Last Update Submitted That Met QC Criteria: December 6, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 22038

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No