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

Not Applicable

Completed

• Conditions: Disc Disorder
• Interventions: Procedure: i-PRF; Procedure: Arthrocentesis

• Registration Number: NCT05640206
• Lead Sponsor: Ege University

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.

Study Timeline

• Study Start: 2019-10-01
• Primary Completion: 2021-07-01
• Study Completion: 2021-07-01
• Study First Submitted: 2022-11-29
• Study First Submitted QC: 2022-11-29
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-06
• Study First Posted: 2022-12-07
• Last Update Posted: 2022-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test group	i-PRF	intra-articular i-PRF injection after arthrocentesis
Control group	Arthrocentesis	only arthrocentesis

Primary Outcome Measures

Name	Time	Method
Change of pain	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 Outcome Measures

Name	Time	Method
Change of maximum mouth opening	at preoperatively, and at 1, 2, 3, 6 and 12 months postoperatively	Maximum mouth opening was measured with a millimeter ruler 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	Lateral movements were measured with a millimeter ruler 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	Protrusive movements were measured with a millimeter ruler at preoperatively and at 1, 2, 3, 6 and 12 months postoperatively

Trial Locations

Locations (1)

Ege University Faculty of Dentistry; 🇹🇷 İzmir, Bornova, Turkey