Computer Guided Versus Conventional TMJ Injection

NCT ID: NCT05288647

Last Updated: 2022-03-31

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-24

Study Completion Date

2021-10-11

Brief Summary

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This study is designed to evaluate the clinical outcomes of computer-guided sodium hyaluronate injection in superior joint space in comparison to conventional injection for treatment of intra-articular TMJ disorder.

Detailed Description

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This study aimed to reveal the superiority of computer-guided TMJ injection (if found) above the conventional method from the clinician and patient point of view.

Conditions

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TMD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Group A

Patients treated with four computer-guided sodium hyaluronate injections in superior TMJ space.

Group Type EXPERIMENTAL

TMJ injection

Intervention Type PROCEDURE

four sodium hyaluronate injections in superior TMJ space

Group B

Patients treated with four conventional sodium hyaluronate injections in superior TMJ space.

Group Type ACTIVE_COMPARATOR

TMJ injection

Intervention Type PROCEDURE

four sodium hyaluronate injections in superior TMJ space

Interventions

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TMJ injection

four sodium hyaluronate injections in superior TMJ 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

* Patients with polyarthritis or degenerative joint disease.
* Patients with myofascial pain.
* Previous history of minimally invasive or invasive treatment of TMJ.
* History of mandibular fracture.
* 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

References

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Krause M, Dorfler HM, Kruber D, Humpfner-Hierl H, Hierl T. Template-based temporomandibular joint puncturing and access in minimally invasive TMJ surgery (MITMJS) - a technical note and first clinical results. Head Face Med. 2019 Apr 2;15(1):10. doi: 10.1186/s13005-019-0194-8.

Reference Type BACKGROUND
PMID: 30940211 (View on PubMed)

Steenks MH, Turp JC, de Wijer A. Reliability and Validity of the Diagnostic Criteria for Temporomandibular Disorders Axis I in Clinical and Research Settings: A Critical Appraisal. J Oral Facial Pain Headache. 2018 Winter;32(1):7-18. doi: 10.11607/ofph.1704.

Reference Type BACKGROUND
PMID: 29370321 (View on PubMed)

Rani S, Pawah S, Gola S, Bakshi M. Analysis of Helkimo index for temporomandibular disorder diagnosis in the dental students of Faridabad city: A cross-sectional study. J Indian Prosthodont Soc. 2017 Jan-Mar;17(1):48-52. doi: 10.4103/0972-4052.194941.

Reference Type BACKGROUND
PMID: 28216845 (View on PubMed)

Other Identifiers

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CG-HA-TMJ-inj.

Identifier Type: -

Identifier Source: org_study_id

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