TMDNCT05288647
Computer Guided Versus Conventional TMJ Injection
A study testing TMJ injection in people with TMD, run by Al-Azhar University at 1 site in Egypt.
Trial 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 more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- TMD
- What is being tested?
- TMJ injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 24 Dec 2019to 11 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Computer-guided Versus Conventional Sodium Hyaluronate Injection in Superior Joint Space in Treatment of Intra-articular TMJ Disorder
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
- TMD
- Being tested
- TMJ injection
- Keywords
- TMD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMJ injectionProcedure or surgery
four sodium hyaluronate injections in superior TMJ space
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Patients treated with four computer-guided sodium hyaluronate injections in superior TMJ space. Receives: Procedure: TMJ injection |
| Group B | Active comparator | Patients treated with four conventional sodium hyaluronate injections in superior TMJ space. Receives: Procedure: TMJ injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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".
Measured: 6 months
Secondary outcomes (2)
Total procedural time.
Total procedural time consumed starting from application of topical antiseptic up to the end of the procedure.
Measured: Baseline
Patient convenience.
Patient convenience on a scale from "0" to "10", where "0" is highly convenient and "10" extremely intolerable.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2022
- Study start24 Dec 2019
- Primary completion7 Apr 2021
- Study completion11 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for TMDStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AbdElKader Ahmed Hyder Mohamed, Al-Azhar University
- Investigators
- AbdElKader A Hyder, MSc, Principal investigator, Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Al-Azhar UniversityWael A ElMohandes, PhD, Study director, Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Al-Azhar UniversityBahaa El-Din A Tawfik, PhD, Study director, Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05288647
- Sponsor's protocol ID
- CG-HA-TMJ-inj.
- Status last verified
- Mar 2022
- First submitted
- 11 Mar 2022
- Last updated
- 31 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 30940211Steenks 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 29370321Rani 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
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Computer-guided Versus Conventional Sodium Hyaluronate Injection in Superior Joint Space in Treatment of Intra-articular TMJ Disorder
- ClinicalTrials.gov ID
- NCT05288647
- Acronym / sponsor ID
- CG-HA-TMJ-inj.
- Conditions
- TMD
- Keywords
- TMD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 24 Dec 2019 (actual)
- Primary completion
- 7 Apr 2021 (actual)
- Study completion
- 11 Oct 2021 (actual)
- First posted
- 21 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: TMJ injectionPatients treated with four computer-guided sodium hyaluronate injections in superior TMJ space. |
| Group B | Active comparator | Procedure: TMJ injectionPatients treated with four conventional sodium hyaluronate injections in superior TMJ space. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TMJ injectionfour sodium hyaluronate injections in superior TMJ space | Procedure or surgery | Group A, Group B |
Primary outcome
Comparison of maximum unassisted mouth opening range
Time frame: 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.
Time frame: 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
Time frame: 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".
2 secondary outcomes
Total procedural time.
Time frame: Baseline
Patient convenience.
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Background: PubMed 30940211Krause 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.
- Background: PubMed 29370321Steenks 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.
- Background: PubMed 28216845Rani 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TMJ injection in people with TMD, run by Al-Azhar University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of maximum unassisted mouth opening range (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05288647, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022; AzTrials last refreshed its copy on 3 Nov 2026.