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

Primary Purpose

TMJ Disc Disorder, Ultrasound Therapy; Complications, TMJ

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Prolotherapy
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for TMJ Disc Disorder

Eligibility Criteria

20 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Patients with TMD - internal derangement with symptomatic clicking pain, according to RDC (Research diagnostic criteria for TMJD) sheet . Muscles spasm causing TMDs. Patients who failed to improve on conservative measures or highly hyperactivity patients. Female and male patients age range from 20 to 60 years old. Exclusion Criteria: Patients who refused to be included in the research. Patients with a systemically diseases or inflammation whether local or generalized. Patients with bleeding disorders. Patients with unknown dextrose allergy.

Sites / Locations

  • CairoURecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ultrasound Guided Prolotherapy forTreatment of Internal Derangement of TMJD.

Non-Guided Ultrasound ( Blind) Prolotherapy for Treatment of Internal Derangement of TMJD.

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

visual analogue scale
psychometric measuring instruments designed to document the characteristics of disease-related symptom severity in individual patients
visual analogue scale
psychometric measuring instruments designed to document the characteristics of disease-related symptom severity in individual patients

Secondary Outcome Measures

Full Information

First Posted
November 15, 2022
Last Updated
February 6, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05627830
Brief Title
Ultrasound Guided Versus Non-Guided Prolotherapy for Internal Derangement of Temporomandibular Joint.
Official Title
Ultrasound Guided Versus Non-Guided Prolotherapy for Internal Derangement of Temporomandibular Joint.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 10, 2022 (Actual)
Primary Completion Date
March 1, 2023 (Anticipated)
Study Completion Date
April 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
TMJ Disc Disorder, Ultrasound Therapy; Complications, TMJ, Prolotherapy, Internal Derangement, Clicking Tinnitus, Injection Site, Pain, Chronic, Anterior Disc Displacement, Myofascial Pain Syndrome, Masticatory Muscle

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ultrasound Guided Prolotherapy forTreatment of Internal Derangement of TMJD.
Arm Type
Experimental
Arm Description
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)
Arm Title
Non-Guided Ultrasound ( Blind) Prolotherapy for Treatment of Internal Derangement of TMJD.
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Procedure
Intervention Name(s)
Prolotherapy
Intervention Description
Prolotherapy is an injection treatment used to relieve pain. And for Cellular Regeneration
Primary Outcome Measure Information:
Title
visual analogue scale
Description
psychometric measuring instruments designed to document the characteristics of disease-related symptom severity in individual patients
Time Frame
Change from Baseline VAS at 4 weeks ( lower score means better outcome)
Title
visual analogue scale
Description
psychometric measuring instruments designed to document the characteristics of disease-related symptom severity in individual patients
Time Frame
VAS change at 2 months ( lower score means better outcome )

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients with TMD - internal derangement with symptomatic clicking pain, according to RDC (Research diagnostic criteria for TMJD) sheet . Muscles spasm causing TMDs. Patients who failed to improve on conservative measures or highly hyperactivity patients. Female and male patients age range from 20 to 60 years old. Exclusion Criteria: Patients who refused to be included in the research. Patients with a systemically diseases or inflammation whether local or generalized. Patients with bleeding disorders. Patients with unknown dextrose allergy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tarek Abdallah EL-Ghareeb, M.D.
Phone
00201227418235
Email
t.elghareeb@dentistry.cu.edu.eg
Facility Information:
Facility Name
CairoU
City
Cairo
State/Province
Al Manial, Old Cairo
ZIP/Postal Code
11553
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Omniya Abdelaziz, M.D.
Phone
00201001202583
Email
omniya.abdelaziz@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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

Learn more about this trial

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

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