Completed

NCT Number: NCT05640206

Effect 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.

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Key information

Conditions

Disc Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ege University Faculty of Dentistry

Izmir, Bornova, 35100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

i-PRF

Procedure

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

Arthrocentesis

Procedure

Arthrocentesis performed with two-needle technique

Primary outcomes

Change of pain

Time frame: 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 outcomes

Change of maximum mouth opening

Time frame: 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

Time frame: 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

Time frame: 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

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Official study title

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

Important dates

Study start: 2019
Primary completion: 2021
Study completion: 2021
First posted: Dec 7, 2022
Registry last updated: Dec 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.