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

Sponsor

Cairo University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05627830

Collaborator

(none)

Enrollment

Location

Arms

2.7

Anticipated Duration (Months)

8.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
TMJ Disc Disorder Ultrasound Therapy; Complications TMJ Prolotherapy Internal Derangement Clicking Tinnitus Injection Site Pain, Chronic Anterior Disc Displacement Myofascial Pain Syndrome Masticatory Muscle	Procedure: Prolotherapy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

22 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jan 10, 2023

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Apr 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

visual analogue scale [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
visual analogue scale [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CairoU	Cairo	Al Manial, Old Cairo	Egypt	11553

Sponsors and Collaborators

Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mohammad Bader AL-Haj Kheder, Oral & Maxillofacial Surgeon, Cairo University

ClinicalTrials.gov Identifier:

NCT05627830

Other Study ID Numbers:

111996

First Posted:

Nov 28, 2022

Last Update Posted:

Jan 10, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Myofascial Pain Syndromes

Fibromyalgia

Tinnitus

Chronic Pain

Study Results

No Results Posted as of Jan 10, 2023