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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05640206
Enrollment
80
Registered
2022-12-07
Start date
2019-10-01
Completion date
2021-07-01
Last updated
2022-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disc Disorder

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.

Interventions

PROCEDUREi-PRF

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

Arthrocentesis performed with two-needle technique

Sponsors

Ege University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change of painat preoperatively, and at 1, 2, 3, 6 and 12 months postoperativelyPain 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

MeasureTime frameDescription
Change of maximum mouth openingat preoperatively, and at 1, 2, 3, 6 and 12 months postoperativelyMaximum mouth opening was measured with a millimeter ruler at preoperatively and at 1, 2, 3, 6 and 12 months postoperatively
Change of lateral movementsat preoperatively, and at 1, 2, 3, 6 and 12 months postoperativelyLateral movements were measured with a millimeter ruler at preoperatively and at 1, 2, 3, 6 and 12 months postoperatively
Change of protrusive movementsat preoperatively, and at 1, 2, 3, 6 and 12 months postoperativelyProtrusive movements were measured with a millimeter ruler at preoperatively and at 1, 2, 3, 6 and 12 months postoperatively

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026