Ultrasound Guided Versus Non-Guided Prolotherapy for Internal Derangement of Temporomandibular Joint.

February 6, 2023 updated by: Mohammad Bader AL-Haj Kheder, Cairo University

Ultrasound Guided Versus Non-Guided Prolotherapy for Treatment of Internal Derangement of Temporomandibular joint.

Rationale for conducting the research:

The most critical cause for guided prolotherapy is to specify the accurate location of glenoid fossa and the disc space while prolotherapy procedure, and to adjust the needle insertion to according to articular eminence, mandibular condyle, and intra-articular space as anatomical variations. The vibration of ultrasound waves generates a heat so there is a thermal effective for prolotherapy effusion in the TMJ space.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

22

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 Locations

  • Egypt
    • Al Manial, Old Cairo
      • Cairo, Al Manial, Old Cairo, Egypt, 11553
        • Recruiting
        • CairoU

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

20 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Patients with TMD - internal derangement with symptomatic clicking pain, according to RDC (Research diagnostic criteria for TMJD) sheet .
  2. Muscles spasm causing TMDs.
  3. Patients who failed to improve on conservative measures or highly hyperactivity patients.
  4. Female and male patients age range from 20 to 60 years old.

Exclusion Criteria:

  1. Patients who refused to be included in the research.
  2. Patients with a systemically diseases or inflammation whether local or generalized.
  3. Patients with bleeding disorders.
  4. Patients with unknown dextrose allergy.

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
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Ultrasound Guided Prolotherapy forTreatment of Internal Derangement of TMJD.

Injection procedure in TMJ Space guided by ultrasound probe the injection materials will be composition of ( !0% Dextrose ) + (Saline ) + (2% Lidocaine, plain anesthesia ).

The intervention procedure will done after TMJ MRI assessment for patients who have anterior disc displacement with reduction (DDWR)
Procedure: Prolotherapy
Prolotherapy is an injection treatment used to relieve pain. And for Cellular Regeneration
ACTIVE_COMPARATOR: Non-Guided Ultrasound ( Blind) Prolotherapy for Treatment of Internal Derangement of TMJD.

Injection procedure in TMJ Space by anatomical land mark (blindly), and we also call it ( conventional prolotherapy ) the injection materials will be composition of ( !0% Dextrose ) + (Saline ) + (2% Lidocaine, plain anesthesia ).

The intervention procedure will done after TMJ MRI assessment for patients who have anterior disc displacement with reduction (DDWR)
Procedure: Prolotherapy
Prolotherapy is an injection treatment used to relieve pain. And for Cellular Regeneration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
visual analogue scale
Time Frame: Change from Baseline VAS at 4 weeks ( lower score means better outcome)
psychometric measuring instruments designed to document the characteristics of disease-related symptom severity in individual patients
Change from Baseline VAS at 4 weeks ( lower score means better outcome)
visual analogue scale
Time Frame: VAS change at 2 months ( lower score means better outcome )
psychometric measuring instruments designed to document the characteristics of disease-related symptom severity in individual patients
VAS change at 2 months ( lower score means better outcome )

Collaborators and Investigators

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

Sponsor

Cairo University

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)

November 10, 2022

Primary Completion (ANTICIPATED)

March 1, 2023

Study Completion (ANTICIPATED)

April 1, 2023

Study Registration Dates

First Submitted

November 15, 2022

First Submitted That Met QC Criteria

November 22, 2022

First Posted (ACTUAL)

November 28, 2022

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 6, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 111996

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data of volunteers will be shared with the doctors supervising the thesis research to assess the status and results of the scientific research

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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