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Computer Guided Visco Supplementation in the Management of Internal Derangement of Temporomandibular Joint

NCT ID: NCT06667791

Last Updated: 2024-10-31

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-03

Study Completion Date

2024-10-24

Brief Summary

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Background: The intra-articular injection is considered the first line of minimally invasive treatment in TMJ-ID patients who do not respond to conservative treatment. Image-guided puncture technique has emerged to add safety, reliability, convenience, and decrease the need for correcting the puncture point.

Aim of the study: To evaluate the feasibility and clinical outcomes of computer-guided superior joint space injection of sodium hyaluronate in the treatment of temporomandibular joint disorder (TMJ-ID) compared with conventional injection

Detailed Description

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Conditions

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Temporomandibular Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Study Group

Group Type EXPERIMENTAL

Computer guided sodium hyaluronate injections

Intervention Type OTHER

Patients will be treated with Computer guided sodium hyaluronate injections in superior TMJ space

Control

Group Type ACTIVE_COMPARATOR

conventional sodiumhyaluronate injections

Intervention Type OTHER

Patients will be treated with conventional sodium hyaluronate injections in superior TMJ space

Interventions

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Computer guided sodium hyaluronate injections

Patients will be treated with Computer guided sodium hyaluronate injections in superior TMJ space

Intervention Type OTHER

conventional sodiumhyaluronate injections

Patients will be treated with conventional sodium hyaluronate injections in superior TMJ space

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 1\. Patients diagnosed with internal derangement according to Wilkins stage I and II.
* Patients who would not respond to conservative treatment as a first line of treatment.

Exclusion Criteria

* Patients with Wilkins stage III, IV, V.
* History of mandibular fracture.
* Lactating, pregnant or planning pregnancy women.
* Known hypersensitivity to hyaluronic acid or clear biocompatible photopolymer resin.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hams Hamed Abdelrahman

OTHER

Sponsor Role lead

Responsible Party

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Hams Hamed Abdelrahman

Assistant Lecturer of Dental Public Health and biostatistical consultant

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Outpatient clinic of Oral and Maxillofacial Surgery

Alexandria, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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0870-04

Identifier Type: -

Identifier Source: org_study_id