Ultrasound Guided Autologous Blood Injection in Temporomandibular Joint Dislocation

February 2, 2024 updated by: Mohamed Abbas Morsy Hussien, Cairo University

Ultrasound -Guided Versus Conventional Non Guided Autologous Blood Injection For Treatment of Patients With Chronic Recurrent Temporomandibular Joint Dislocation. A Randomized Clinical Trial

The aim of this study is To compare the accuracy and effectiveness of ultrasound (US) guided autologous blood injection (ABI) versus non- guided technique for the treatment of chronic recurrent temporomandibular joint dislocation

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

All patients involved in this study will be divided randomly to two different groups and injected with autologous blood into joint space and pericapsular tissue.

Study group (group A) will be injected with autologous blood with ultrasound guidance.

control group (group B) will be injected with autologous blood without US guidance. Anatomical landmarks and tactical sense will be followed only.

The operation will be done under local anesthesia ( Auriculotemporal nerve block ) the skin overlying the temporomandibular joint will be scrubbed by an antiseptic solution and the area will be isolated with sterile towels. External auditory canal will be blocked with cotton.

About 3 ml of blood will be withdrawn from patient's antecubital fossa, of which 2 ml injected intra-articular and 1 ml in the pericapsular tissue (PT) The procedure should be repeated on the opposite side in case of bilateral involvement.

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patient with at least 3 episodes of temporomandibular joint dislocation in the past 6 months.
  • Necessitating a visit to the emergency room or trained professional to reduce the dislocation.
  • Radiological evidence of displacement of condylar head beyond the articular eminence on wide mouth opening.
  • Maximum mouth opening (MMO) more than 40 mm.
  • Unilateral or bilateral.
  • Over 18 years of age.
  • Both gender Males or females.

Exclusion Criteria:

  • Patient having inflammatory temporomandibular joint disease like tuberculous arthritis, rheumatoid arthritis.
  • Patients with bleeding disorders, pregnancy or bony pathology of temporomandibular joint .
  • Allergy to local anesthetic.
  • Severe epilepsy or Parkinson's disease.
  • Patient on anti-depressants or anti-psychotics.
  • Inability to follow-up the patient during the entire follow-up period.
  • Patients who had recent fracture at temporomandibular joint level or who had previous surgical interference to temporomandibular joint .
  • Refused to sign the written informed consent were also excluded.
  • Dystonia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Study group (group A) will be injected with ultrasound guidance in temporomandibular joint .
uses of ultrasound as a guiding tool for temporomandibular joint injection
Procedure: ultrasound guided autologous blood injection
guided
Placebo Comparator: control group(group B) conventional non guided injection in temporomandibular joint
without ultrasound guidance only anatomical landmark will be followed during injection
Procedure: non guided autologous blood injection
non guided

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
maximum mouth opening
Time Frame: at 2weeks, 3months and 6 months post-operative
change in Maximum mouth opening (MMO): It's measured (in millimeter) from incisal edge of 11 to 41, in maximum mouth open position using caliper
at 2weeks, 3months and 6 months post-operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of temporomandibular joint dislocation:
Time Frame: 2weeks, 3 months and 6 months post-operatively
number of dislocation per week
2weeks, 3 months and 6 months post-operatively
change of pain
Time Frame: 2weeks, 3 months and 6 months post-operatively
measuring pain using visual analogue scale(0-10),higher scores mean worse outcome.
2weeks, 3 months and 6 months post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

January 25, 2024

First Submitted That Met QC Criteria

February 2, 2024

First Posted (Actual)

February 6, 2024

Study Record Updates

Last Update Posted (Actual)

February 6, 2024

Last Update Submitted That Met QC Criteria

February 2, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 291123

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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