NCT05938257

Brief Summary

Temporomandibular joint dysfunction (TMD) represents a common health problem. A recent systematic review and meta-analysis in 2021 concluded that the prevalence of TMD was 31% for adults and 11% for adolescence. Many believe that TMD symptoms are related to internal derangement of the temporomandibular joint (TMJ), which is usually in the form of anterior disc displacement(ADD) and it is often associated with pain, clicking, limited range of motion, and even osteoarthritic changes. Treatment of TMD include non-surgical and surgical modalities. Non-surgical treatment includes instructions, pharmacotherapy, occlusal splints and physiotherapy. Patients who do not respond to non-surgical therapy may require surgical interventions that include minimally invasive procedures (arthroscopy and arthrocentesis) and open surgery. Arthroscopy of the TMJ was first introduced by Ohnishi in 1975, it involves lysis of adhesions and lavage of the superior joint space, as well as repositioning of a displaced disc. Open TMJ surgery can be very effective at eliminating symptoms of pain, limited mouth opening and mandibular dysfunction.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

June 20, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 10, 2023

Completed
22 days until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

July 10, 2023

Status Verified

July 1, 2023

Enrollment Period

1.9 years

First QC Date

June 20, 2023

Last Update Submit

July 3, 2023

Conditions

Efficacy of TMJ Arthroscopy

Outcome Measures

Primary Outcomes (1)

  • TMJ pain

    change of pain on a visual analogue scale from 0 to 10 with decreased number means less pain

    one year

Study Arms (1)

TMJ dysfunction

EXPERIMENTAL

TMJ discopexy

Procedure: TMJ discopexy

Interventions

TMJ discopexyPROCEDURE

Arthroscopic versus open TMJ discopexy

TMJ dysfunction

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with TMD in the form of anterior disc displacement without reduction
  • Age: 20 - 50 years' old

You may not qualify if:

  • Secondary TMD
  • TMJ ankylosis
  • Structural deformity of TMJ
  • Previous surgical intervention to TMJ
  • Patients who are unfit for surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university hospital

Asyut, Government, 71111, Egypt

RECRUITING

Central Study Contacts

Mohamed G Thabet, physician

CONTACT

01026674177mohamed.g.t772@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: randomized controlled clinical trial
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assiut university

Study Record Dates

First Submitted

June 20, 2023

First Posted

July 10, 2023

Study Start

August 1, 2023

Primary Completion

July 1, 2025

Study Completion

August 1, 2025

Last Updated

July 10, 2023

Record last verified: 2023-07

Locations

EG(1)