Computer Guided Versus Conventional TMJ Injection

Efficacy of Computer-guided Versus Conventional Sodium Hyaluronate Injection in Superior Joint Space in Treatment of Intra-articular TMJ Disorder

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05288647

Enrollment

Registered

2022-03-21

Start date

2019-12-24

Completion date

2021-10-11

Last updated

2022-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

TMD

Keywords

TMD

Brief summary

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

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.

Interventions

PROCEDURETMJ injection

four sodium hyaluronate injections in superior TMJ space

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 40 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Comparison of maximum unassisted mouth opening range	6 months	Opening range determined by asking the patient to gently open the mouth and measure the distance between upper and lower central incisor using an vernier digital electronic caliper. Vertical movement of the mandible corrected by adding the vertical overlap.
Comparison of modified Helkimo's clinical dysfunction index.	6 months	A modified version of Helkimo's clinical dysfunction index calculated to assess the TMJ dysfunction.
Comparison of pain intensity on Visual analog scale	6 months	Patients asked to mark their TMJ-related pain level on a scale from 0 to 10, where 0 is no pain and 10 is severe pain.

Secondary

Measure	Time frame	Description
Total procedural time.	Baseline	Total procedural time consumed starting from application of topical antiseptic up to the end of the procedure.
Patient convenience.	Baseline	Patient convenience on a scale from 0 to 10, where 0 is highly convenient and 10 extremely intolerable.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026