NCT06850142

Brief Summary

Discopexy is a surgical procedure aimed at stabilizing the articular disc within the temporomandibular joint (TMJ) in patients experiencing TMJ disorders (TMD). The TMJ is a complex joint responsible for jaw movement, and its proper function relies on the alignment and stability of the articular disc, a fibrocartilaginous structure that cushions the joint. In cases of disc displacement or dysfunction, patients may experience pain, clicking, limited jaw movement, and other symptoms.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 5, 2022

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 19, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 22, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 27, 2025

Completed
Last Updated

February 27, 2025

Status Verified

February 1, 2025

Enrollment Period

2.5 years

First QC Date

February 22, 2025

Last Update Submit

February 24, 2025

Conditions

Temporomandibular Joint Disc DisplacementTemporomandibular Joint Disc Displacement, Without Reduction

Keywords

External ear cartilageAnterior disc displacement without reduction.Temporal fascia

Outcome Measures

Primary Outcomes (1)

  • The Visual Analog Scale (VAS)

    The Visual Analog Scale (VAS) It consists of a straight line, typically 10 centimeters (100 mm) in length, with one end labeled "No Pain" and the other end labeled "Worst Pain Imaginable."

    baseline, 1 month, 3 months, 6 months

Secondary Outcomes (2)

  • Disc position

    baseline, 1 month, 3 months, 6 months

  • Maximum Mouth opening

    baseline, 1 month, 3 months, 6 months

Study Arms (2)

discopexy of Temporo-mandibular joint (TMJ) disc to external ear cart

EXPERIMENTAL

30 patients underwent discopexy of Temporo-mandibular joint (TMJ) disc to external ear cartilage

Procedure: Discopexy to external ear cartilage

discopexy of TMJ disc to temporal fascia.

ACTIVE COMPARATOR

Patients underwent discopexy of TMJ disc to temporal fascia.

Procedure: Discopexy to temporal fascia

Interventions

Discopexy to external ear cartilagePROCEDURE

stabilizing the articular disc within the temporomandibular joint (TMJ) in patients experiencing TMJ disorders (TMD) to external ear cartilage

discopexy of Temporo-mandibular joint (TMJ) disc to external ear cart
Discopexy to temporal fasciaPROCEDURE

stabilizing the articular disc within the temporomandibular joint (TMJ) in patients experiencing TMJ disorders (TMD) to temporal fascia

discopexy of TMJ disc to temporal fascia.

Eligibility Criteria

Age35 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with primary TMD with complete anterior disc displacement without reduction with no or minimal osteoarthritic changes

You may not qualify if:

  • osteoarthritis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry- Fayoum University

Al Fayyum, 63514, Egypt

Location

Related Publications (3)

  • Gonzalez LV, Lopez JP, Orjuela MP, de la Sen O, Diaz-Baez D, Martin-Granizo R. Could temporomandibular joint arthroscopic discopexy with resorbable pins or disc mobilisation influence mandibular condyle marrow? Br J Oral Maxillofac Surg. 2025 Jan;63(1):39-46. doi: 10.1016/j.bjoms.2024.10.226. Epub 2024 Oct 10.

    PMID: 39592295BACKGROUND

  • Jerez-Frederick D, Albers D, Fuenzalida C, Laissle G, Avila-Oliver C. Is the Complexity of Arthroscopic Temporomandibular Joint Surgery Associated With Short-Term Complication Rates? J Oral Maxillofac Surg. 2025 Mar;83(3):270-278. doi: 10.1016/j.joms.2024.11.008. Epub 2024 Nov 20.

    PMID: 39645229RESULT

  • Renapurkar SK. Discectomy Versus Disc Preservation for Internal Derangement of the Temporomandibular Joint. Oral Maxillofac Surg Clin North Am. 2018 Aug;30(3):329-333. doi: 10.1016/j.coms.2018.05.002. Epub 2018 Jun 7.

    PMID: 29885876RESULT

Study Officials

  • Alshaimaa shabaan, PhD

    Fayoum University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Oral & Maxillofacial Surgery

Study Record Dates

First Submitted

February 22, 2025

First Posted

February 27, 2025

Study Start

January 5, 2022

Primary Completion

July 19, 2024

Study Completion

January 22, 2025

Last Updated

February 27, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)