Accuracy of Patient Specific Guide for TMJ Injection

NCT ID: NCT05522114

Last Updated: 2022-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-19

Study Completion Date

2022-08-22

Brief Summary

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This study is designed to evaluate the accuracy of planned needle position using patient specific guide during TMJ superior joint space injection.

Detailed Description

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The actual position of the needle evaluated in comparison to the planned one using MSCT while the patient wearing the customized needle guide.

Conditions

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TMD

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patient specific guided injection

Patients treated with HA injection in TMJ using PSG and the accuracy evaluated using MSCT.

Group Type EXPERIMENTAL

TMJ injection using patient specific guide

Intervention Type PROCEDURE

Prefabricated patient specific guide used to guide the needle into the superior joint space of TMJ while real time MSCT evaluate the accuracy of needle position. Sodium hyaloronate injected within the superior joint space.

Interventions

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TMJ injection using patient specific guide

Prefabricated patient specific guide used to guide the needle into the superior joint space of TMJ while real time MSCT evaluate the accuracy of needle position. Sodium hyaloronate injected within the superior joint space.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients diagnosed with intra-articular TMJ disorder according to Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD).
* Patients who would not respond to conservative treatment as the first line of treatment.

Exclusion Criteria

* Lactating, pregnant or planning pregnancy women.
* Known hypersensitivity to hyaluronic acid or clear biocompatible photopolymer resin.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

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AbdElKader Ahmed Hyder Mohamed

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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AbdElKader A Hyder, MSc

Role: PRINCIPAL_INVESTIGATOR

Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Al-Azhar University

Wael A ElMohandes, PhD

Role: STUDY_DIRECTOR

Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Al-Azhar University

Bahaa El-Din A Tawfik, PhD

Role: STUDY_DIRECTOR

Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Al-Azhar University

Locations

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Faculty of Dentistry, Al-Azhar University.

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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PSG-TMJ-acc.

Identifier Type: -

Identifier Source: org_study_id

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