CompletedNCT05288647Updated Mar 31, 2022

Computer Guided Versus Conventional TMJ Injection

An interventional study of TMJ injection in TMD, sponsored by Al-Azhar University. Completed at 1 site in Egypt. Open to participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2022-03-31.

Sponsored by Al-Azhar University · Not applicable, Interventional, and Treatment

From the registry’s dates

Registered 2 years 2 months after the study started (first participant enrolled Dec 2019, registered Mar 2022).

Phase: Not applicable
Study type: Interventional
Enrollment: 40
Allocation: Randomized
Ages: 20 Years to 40 Years
Sex: All

Study 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.

Read the 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.

Conditions studied

Keywords

In context

Lead sponsor

Al-Azhar University is the lead sponsor of 525 studies on the registry; 171 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 20 Years to 40 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Outcomes assessor)
Enrollment: 40 participants (actual)

Study arms

Experimental
Group A
Patients treated with four computer-guided sodium hyaluronate injections in superior TMJ space.
Procedure: TMJ injection
Active comparator
Group B
Patients treated with four conventional sodium hyaluronate injections in superior TMJ space.
Procedure: TMJ injection

Interventions

ProcedureTMJ injection
four sodium hyaluronate injections in superior TMJ space

What researchers measure

Primary outcomes

Comparison of maximum unassisted mouth opening range
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.
Time frame: 6 months
Comparison of modified Helkimo's clinical dysfunction index.
A modified version of Helkimo's clinical dysfunction index calculated to assess the TMJ dysfunction.
Time frame: 6 months
Comparison of pain intensity on Visual analog scale
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".
Time frame: 6 months

Secondary outcomes

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

Study locations

1 site

Faculty of Dentistry, Al-Azhar University.
Cairo, 11884, Egypt

References and documents

Publications

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. PubMed 30940211 ↗
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. PubMed 29370321 ↗
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. PubMed 28216845 ↗

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Ran from Dec 2019 to primary completion in Apr 2021, 15 months.

How these figures are worked out, and which studies are left out of them.

Registered: Mar 11, 2022
First posted: Mar 21, 2022
StartActual: Dec 24, 2019
Primary completionActual: Apr 7, 2021
CompletionActual: Oct 11, 2021
Last update: Mar 31, 2022

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Mar 31, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05288647
Lead sponsor: Al-Azhar University
Responsible party: AbdElKader Ahmed Hyder Mohamed (Principal Investigator, Al-Azhar University) — Principal investigator
First posted: Mar 21, 2022
Start date: Dec 24, 2019
Primary completion: Apr 7, 2021
Completion: Oct 11, 2021
Last update: Mar 31, 2022

Study contacts

AbdElKader A Hyder, MSc

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

Wael A ElMohandes, PhD

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

Bahaa El-Din A Tawfik, PhD

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

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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