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

NCT05640206 | Completed

• 1 other identifier: 22038
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Disc Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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 Arms (2)

Test group

EXPERIMENTAL

intra-articular i-PRF injection after arthrocentesis

Procedure: i-PRF

Control group

EXPERIMENTAL

only arthrocentesis

Procedure: Arthrocentesis

Interventions

i-PRF PROCEDURE

Arthrocentesis performed with two-needle technique, and then injection of i-PRF intra-articularly

Test group

Arthrocentesis PROCEDURE

Arthrocentesis performed with two-needle technique

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• unilateral or bilateral disc displacement without reduction
• localized pain on temporomandibular joint
• decreased mouth opening, lateral and protrusive movements

You may not qualify if:

• Malignant or inflammatory disorders
• prior surgical history of temporomandibular joint

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University Faculty of Dentistry

Izmir, Bornova, 35100, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Arthrocentesis

Intervention Hierarchy (Ancestors)

Paracentesis; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Gözde Işık

  Ege University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistan Professor

Study Record Dates

• First Submitted: November 29, 2022
• First Posted: December 7, 2022
• Study Start: October 1, 2019
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: December 8, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)