NCT05320770

Brief Summary

Evaluation of US efficiency in assessment of the tempromandibular joint disorders in comparison with MRI as the gold standard for technique validation and evaluation of efficiency of therapeutic intra articular injection under sonographic guidance .

Trial Health

35
At Risk

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 Feb 2023

Shorter than P25 for not_applicable

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 11, 2022

Completed
10 months until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

January 11, 2023

Status Verified

January 1, 2023

Enrollment Period

28 days

First QC Date

February 13, 2022

Last Update Submit

January 10, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change of temporomandibular joint imaging by ultrasonography and magnetic resonance imaging .

    Imaging of the temporomandibular joint by ultrasonography and imaging by magnetic resonance imaging .

    Ultrasonography at baseline visit and MRI one week after baseline visit .

  • Change of mobility of the temporomandibular joint before and after ultrasonography guided blood injection .

    Measuring the temporomandibular joint mobility in millimeters by ultrasonography before and after sonar guided injection .

    Baseline visit and three months after the baseline intervention .

Study Arms (1)

TMD patients with joint hyper mobility

EXPERIMENTAL
Procedure: US guided TMJ intra articular injection

Interventions

therapeutic TMJ intra articulatr injection of blood under sonography guidance to reduce joint hyper mobility

TMD patients with joint hyper mobility

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female diagnosed as TMJ disorders (clinically through history of the presentation and physical examination (site, onset, character of pain, radiation, duration and associated symptoms. This pain may refer to the scalp or neck, and is often exacerbated by mastication, yawning or talking for extended periods. Difficulty opening the mouth, clicking, popping or crepitus within the TMJ itself and brief locking of the mandible on jaw opening and closure and Headache, particularly tension type headache).

You may not qualify if:

  • Uncooperative patients, systemic disease with TMJ involvement as Rheumatoid, psoriatic, and juvenile idiopathic arthritis. Contraindications for MRI : claustrophobia , metallic implants , pacemaker and prosthetic heart valves .Contraindication for intra articular injection : the patients with bleeding disorders , pregnancy , bony pathology of TMJ , allergy to local anesthetic and those on narcotics or anti depressant .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Central Study Contacts

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
Resident in Interventional and Diagnostic Department ,Sohag University Hospital

Study Record Dates

First Submitted

February 13, 2022

First Posted

April 11, 2022

Study Start

February 1, 2023

Primary Completion

March 1, 2023

Study Completion

April 1, 2023

Last Updated

January 11, 2023

Record last verified: 2023-01