Application of Injectable Platelet-Rich Fibrin for the Treatment of Temporomandibular Joint Osteoarthritis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-02

Study Completion Date

2019-12-02

Brief Summary

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The authors designed a randomized, controlled, double-blind clinical trial after the ethical approval by the University Ethics Committee. The patients with temporomandibular joint osteoarthritis (TMJ-OA) randomly assigned one of the two treatment groups: intra-articular injection of injectable platelet-rich fibrin (i-PRF) after arthrocentesis procedure as i-PRF group and arthrocentesis procedure alone as control group. The primary outcome variable was pain levels at preoperatively, and postoperatively at 1st, 2nd, 3rd, 6th and 12th month. The secondary outcome variables included maximum mouth opening (MMO), lateral and protrusive movements.

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Detailed Description

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The authors designed a randomized, controlled, double-blind clinical trial after the ethical approval by the University Ethics Committee. The patients with TMJ-OA randomly assigned one of the two treatment groups: intra-articular injection of i-PRF after arthrocentesis procedure as i-PRF group and arthrocentesis procedure alone as control group. All treatment procedures were completed by the same experienced surgeon under the local anesthesia. The procedure of arthrocentesis was performed using the standard technique and after arthrocentesis procedure, the i-PRF injection was performed in the test group.

The primary outcome variable was pain levels at preoperatively, and postoperatively at 1st, 2nd, 3rd, 6th and 12th month. The secondary outcome variables included maximum mouth opening (MMO), lateral and protrusive movements.

Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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i-PRF group

arthrocentesis procedure plus four consecutive intra-articular injection of i-PRF.

Group Type EXPERIMENTAL

i-PRF

Intervention Type PROCEDURE

intra-articular i-PRF injection after arthrocentesis

Control group

arthrocentesis procedure alone.

Group Type EXPERIMENTAL

Arthrocentesis

Intervention Type PROCEDURE

Arthrocentesis procedure with 2 to 3 mL saline solution to lavage the superior compartment of temporomandibular joint.

Interventions

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i-PRF

intra-articular i-PRF injection after arthrocentesis

Intervention Type PROCEDURE

Arthrocentesis

Arthrocentesis procedure with 2 to 3 mL saline solution to lavage the superior compartment of temporomandibular joint.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* patients with osteoarthritis (OA) of one or two temporomandibular joint (TMJ)
* maximum mouth opening less than 35 mm
* impeded protrusive and lateral movements
* localized pain of the affected joint

Exclusion Criteria

* systemic or malignant diseases affecting TMJ-OA assessment
* previous invasive or surgical treatments of TMJ unrelated to OA
* edentulous patients
* pregnancy

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes