NCT07535073

Brief Summary

To compare the clinical effectiveness of ultrasound-guided versus arthroscopic guided platelet rich fibrin injection in the management of anterior disc displacement with reduction of the temporomandibular joint, in terms of pain reduction, improvement of mandibular function, and patient-reported outcomes.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
13mo left

Started May 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 2, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 16, 2026

Completed
21 days until next milestone

Study Start

First participant enrolled

May 7, 2026

Expected
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2027

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 7, 2027

Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

9 months

First QC Date

April 2, 2026

Last Update Submit

April 9, 2026

Conditions

TMJ Disc Displacement With Reduction

Keywords

temporomandibular jointTmj disc displacementPRF

Outcome Measures

Primary Outcomes (1)

  • Maximum mouth opening

    Maximum interincisal distance measured using digital caliper in millimeters (mm) between upper and lower central incisors, Unit of measure: millimeters (mm). Minimum value: 0 mm. Maximum value: 60 mm. Higher values represent a better outcome.

    6 months

Secondary Outcomes (1)

  • Pain intensity

    6 months

Study Arms (2)

Ultrasound guided platelet rich fibrin injection.

EXPERIMENTAL

Patient receive PRF injection under ultrasound guidance

Device: ultrasound guided platelet rich fibrin injection

Arthroscopic guided platelet-rich fibrin injection.

EXPERIMENTAL

Patient receive PRF injection under arsothscopic guidance

Device: Arthroscopic guided platelet rich Fibrin injection

Interventions

ultrasound guided platelet rich fibrin injectionDEVICE

1. A high-frequency linear ultrasound probe will be used to identify the TMJ space. 2. A sterile syringe containing 1 mL of PRF will be inserted into the superior joint space under real-time ultrasound guidance. 3. PRF will be injected slowly with continuous confirmation of needle position.

Ultrasound guided platelet rich fibrin injection.
Arthroscopic guided platelet rich Fibrin injectionDEVICE

1. TMJ arthroscopy will be performed under local or general anesthesia following standard aseptic preparation. 2. The superior joint space will be visualized using a 1.9 mm arthroscope. 3. A sterile syringe containing 1 mL of PRF will be introduced through a lateral portal under direct arthroscopic visualization. 4. PRF will be injected slowly into the superior joint space.

Arthroscopic guided platelet-rich fibrin injection.

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients aged 18-60 years.
  • Clinically and radiographically diagnosed temporomandibular joint disc displacemet with reduction.
  • Presence of TMJ pain exacerbated by mandibular movement.
  • Limited mandibular function and/or reduced maximum mouth opening.
  • Symptoms persisting for at least 3 months.
  • Failure of conservative treatment (e.g. occlusal splint, physiotherapy, NSAIDs). -Ability to understand the study protocol and provide informed consent.

You may not qualify if:

  • Previous TMJ surgery or arthroscopic intervention.
  • Intra-articular injection in the TMJ within the last 6 months.
  • Systemic inflammatory or autoimmune joint diseases.
  • Coagulation disorders or current anticoagulant therapy.
  • Active local infection at the injection site.
  • Pregnancy or lactation.
  • Severe degenerative joint disease (advanced osteoarthritis).
  • Known allergy or contraindication to ( PRF) preparation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • González LV, López JP, Díaz-Báez D, Orjuela MP, Chavez M. Clinical outcomes of operative arthroscopy and temporomandibular medical infiltration with platelet-rich fibrin in upper and lower articular space. J Cranio-Maxillofac Surg. 2021;49:1162-1168.

    BACKGROUND

  • Chaudhary FA, Ahmad B, Butt DQ, Hameed S, Bashir U. Normal range of maximum mouth opening in Pakistani population: A cross-sectional study. J Int Oral Health. 2019;11(6):353-356. doi:10.4103/jioh.jioh_127_19.

    BACKGROUND

Related Links

Central Study Contacts

Sami Faiz Kahwaji, DDS

CONTACT

+20 1096094940sami.kahwaji@dentistry.cu.edu.eg

Khalid Atef Elhayes, PhD

CONTACT

+20 1030000360khaled.atef@dentistry.cu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator, postgraduate researcher

Study Record Dates

First Submitted

April 2, 2026

First Posted

April 16, 2026

Study Start (Estimated)

May 7, 2026

Primary Completion (Estimated)

February 7, 2027

Study Completion (Estimated)

June 7, 2027

Last Updated

April 16, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

No IPD sharing plan at this time due to data sensitivity, ongoing sponsor review, and lack of established infrastructure.