NCT05804695

Brief Summary

  • Analgesics
  • Antibiotic coverage
  • MRI 6 months postoperative to assess disc reduction
  • Follow up appointment one week, one month ,three months and 6 months (Buttons will be removed two weeks postoperatively) To assess the disc position and testing for any facial nerve affection Then, measurements of the maximum mouth opening in millimeters.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2020

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

February 20, 2020

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2023

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2023

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 27, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 7, 2023

Completed
Last Updated

April 7, 2023

Status Verified

March 1, 2023

Enrollment Period

3.1 years

First QC Date

March 27, 2023

Last Update Submit

March 27, 2023

Conditions

Temporomandibular Joint Disc Displacement

Outcome Measures

Primary Outcomes (1)

  • Change in the measurements of the maximum inter-incisal opening (MIO)

    Change in the measurements of the maximum inter-incisal opening (MIO) in millimeter measured by a ruler preoperatively and postoperatively in the follow up appointments.

    pre surgery and after 6 months from surgery

Study Arms (1)

Arthroscopic Temporo-mandibular joint disc repositioning under General anathesia

EXPERIMENTAL
Procedure: Arthroscopic TMJ disc repositioning under GA

Interventions

Arthroscopic TMJ disc repositioning under GAPROCEDURE

a surgical procedure used to treat Tempro- mandibular disc displacement using arthroscope.

Arthroscopic Temporo-mandibular joint disc repositioning under General anathesia

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Clinical diagnosis of TMJ disorder (Pain, limitation and/or locking)
  • Unilateral or bilateral TMJ internal derangement Wilkes stage III, IV
  • Failed Conservative treatment for two months if it was indicated
  • Age between 20- 50 years old

You may not qualify if:

  • Systemic Disease such as uncontrolled Diabetes, uncontrolled hypertension
  • Patient who had a previous Intracapsular TMJ surgery
  • Tumors and TMJ ankylosis
  • Edentulous patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Future University in Egypt

Cairo, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer of Prosthodontics

Study Record Dates

First Submitted

March 27, 2023

First Posted

April 7, 2023

Study Start

February 20, 2020

Primary Completion

March 20, 2023

Study Completion

March 25, 2023

Last Updated

April 7, 2023

Record last verified: 2023-03

Locations

EG(1)