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

NCT ID: NCT05640206

Last Updated: 2022-12-08

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

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2021-07-01

Brief Summary

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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

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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.

Conditions

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Disc Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Test group

intra-articular i-PRF injection after arthrocentesis

Group Type EXPERIMENTAL

i-PRF

Intervention Type PROCEDURE

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

Control group

only arthrocentesis

Group Type EXPERIMENTAL

Arthrocentesis

Intervention Type PROCEDURE

Arthrocentesis performed with two-needle technique

Interventions

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i-PRF

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

Intervention Type PROCEDURE

Arthrocentesis

Arthrocentesis performed with two-needle technique

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ege University

OTHER

Sponsor Role lead

Responsible Party

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Gözde Işık

Assistan Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gözde Işık

Role: PRINCIPAL_INVESTIGATOR

Ege University

Locations

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Ege University Faculty of Dentistry

Izmir, Bornova, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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22038

Identifier Type: -

Identifier Source: org_study_id

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