NCT06661096

Brief Summary

Temporomandibular joint dysfunction (TMJD) represents a common health problem. Its prevalence is nearly 31% in adults and 11% in adolescence, more common in females. Aetiologies of TMJD are multifactorial and can be attributed to both physical and psycho-social factors. Internal derangement of the temporomandibular joint (TMJ) is the most frequent disorder; with anterior disc displacement is the most common form. Wilkes has classified internal derangement into five stages; patients with stage III usually present with limited mouth opening, joint pain and deviation of jaw upon opening to the affected side. MRI is considered the gold standard for diagnosis. Treatment of TMJD include non-surgical and surgical methods. Non-surgical treatment includes instructions, pharmacotherapy, physiotherapy and occlusal splints; while surgical interventions include minimally invasive procedures (arthroscopy and arthrocentesis) and open joint surgery

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
active not 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

Study Start

First participant enrolled

October 13, 2024

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

October 21, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 28, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 13, 2025

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2025

Completed
Last Updated

October 28, 2024

Status Verified

October 1, 2024

Enrollment Period

1 year

First QC Date

October 21, 2024

Last Update Submit

October 25, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • maximum inter-incisal opening

    change of maximum inter-incisal opening, in mm.

    6 months

Study Arms (1)

TMJ dysfunction

EXPERIMENTAL

TMJ arthroscopy

Procedure: TMJ arthroscopy

Interventions

level I and level II TMJ arthroscopy

TMJ dysfunction

Eligibility Criteria

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

You may qualify if:

  • Wilkes stage III patients

You may not qualify if:

  • previous TMJ surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university

Asyut, Asyut Governorate, 71111, Egypt

Location

MeSH Terms

Conditions

Temporomandibular Joint Dysfunction Syndrome

Condition Hierarchy (Ancestors)

Temporomandibular Joint DisordersCraniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesMyofascial Pain SyndromesStomatognathic Diseases

Study Officials

  • Mohamed Gamal Thabet, MD

    MGThabet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

October 21, 2024

First Posted

October 28, 2024

Study Start

October 13, 2024

Primary Completion

October 13, 2025

Study Completion

October 15, 2025

Last Updated

October 28, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations