Temporomandibular DisorderNCT06667791
Computer Guided Visco Supplementation in the Management of Internal Derangement of Temporomandibular Joint
A study testing Computer guided sodium hyaluronate injections and conventional sodiumhyaluronate injections in people with Temporomandibular Disorder, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Temporomandibular Disorder
- What is being tested?
- Computer guided sodium hyaluronate injections and conventional sodiumhyaluronate injections
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 3 May 2024to 24 Oct 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient clinic of Oral and Maxillofacial Surgery
Alexandria, 00302
About this study
Official title: Evaluation of Computer-guided Visco Supplementation in the Management of Internal Derangement of Temporomandibular Joint (a Randomized Controlled Clinical Trial)
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
- Conditions
- Temporomandibular Disorder
- Being tested
- Computer guided sodium hyaluronate injections, conventional sodiumhyaluronate injections
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer guided sodium hyaluronate injectionsOther
Patients will be treated with Computer guided sodium hyaluronate injections in superior TMJ space
conventional sodiumhyaluronate injectionsOther
Patients will be treated with conventional sodium hyaluronate injections in superior TMJ space
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Not described Receives: Other: Computer guided sodium hyaluronate injections |
| Control | Active comparator | Not described Receives: Other: conventional sodiumhyaluronate injections |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in TMJ dysfunction
A modified version of Helkimo's clinical dysfunction index (Di) is be calculated to assess the TMJ dysfunction as follows:
- Maximum unassisted mouth opening range: Opening range will be determined by asking the patient to gently open mouth and measure the distance between upper and lower central incisors.
- Mandibular deviation during opening: Patients will be asked to open mouth gently and deviation will be noted between maxillary and mandibular midline, score 0 - if <2 mm, score 1 - if 2-5 mm, and score 5 - if >5 mm
Measured: Baseline, 1 month, and 3 months
change in pain score
Pain level was determined by the patient's self-assessment using a visual analog scale (VAS) from zero to 10 ("0" is pain-free and "10" is severe intolerable pain).
Measured: Baseline,1 months, and 3 months
Secondary outcomes (2)
Duration of operation
Total procedural time consumed starting from the application of topical antiseptic up to the end of the procedure.
Measured: Baseline
Number of Needle Relocation
The need to relocate the needle after first puncture of both needles will be used to compare between the efficacies of the computer guided arthrocentesis guide and the conventional free hand arthrocentesis.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start3 May 2024
- Primary completion21 Aug 2024
- Study completion24 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular DisorderStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hams Hamed Abdelrahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hams Hamed Abdelrahman, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06667791
- Sponsor's protocol ID
- 0870-04
- Status last verified
- Oct 2024
- First submitted
- 30 Oct 2024
- Last updated
- 31 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Atmeh BSK, El Dibany RM, El-Mahallawy Y. Evaluation of computer-guided visco-supplementation in the management of internal derangement of temporomandibular joint: a randomized controlled clinical trial. Oral Surg Oral Med Oral Pathol Oral Radiol. 2025 Oct;140(4):416-427. doi: 10.1016/j.oooo.2025.04.098. Epub 2025 Apr 29.
PubMed 40645842
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Computer-guided Visco Supplementation in the Management of Internal Derangement of Temporomandibular Joint (a Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT06667791
- Acronym / sponsor ID
- 0870-04
- Conditions
- Temporomandibular Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 3 May 2024 (actual)
- Primary completion
- 21 Aug 2024 (actual)
- Study completion
- 24 Oct 2024 (actual)
- First posted
- 31 Oct 2024 (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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Other: Computer guided sodium hyaluronate injections |
| Control | Active comparator | Other: conventional sodiumhyaluronate injections |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Computer guided sodium hyaluronate injectionsPatients will be treated with Computer guided sodium hyaluronate injections in superior TMJ space | Other | Study Group |
| conventional sodiumhyaluronate injectionsPatients will be treated with conventional sodium hyaluronate injections in superior TMJ space | Other | Control |
Primary outcome
Change in TMJ dysfunction
Time frame: Baseline, 1 month, and 3 months
A modified version of Helkimo's clinical dysfunction index (Di) is be calculated to assess the TMJ dysfunction as follows: * Maximum unassisted mouth opening range: Opening range will be determined by asking the patient to gently open mouth and measure the distance between upper and lower central incisors. * Mandibular deviation during opening: Patients will be asked to open mouth gently and deviation will be noted between maxillary and mandibular midline, score 0 - if <2 mm, score 1 - if 2-5 mm, and score 5 - if >5 mm
change in pain score
Time frame: Baseline,1 months, and 3 months
Pain level was determined by the patient's self-assessment using a visual analog scale (VAS) from zero to 10 ("0" is pain-free and "10" is severe intolerable pain).
2 secondary outcomes
Duration of operation
Time frame: Baseline
Number of Needle Relocation
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 Oct 2024.
- Derived from this study: PubMed 40645842Atmeh BSK, El Dibany RM, El-Mahallawy Y. Evaluation of computer-guided visco-supplementation in the management of internal derangement of temporomandibular joint: a randomized controlled clinical trial. Oral Surg Oral Med Oral Pathol Oral Radiol. 2025 Oct;140(4):416-427. doi: 10.1016/j.oooo.2025.04.098. Epub 2025 Apr 29.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer guided sodium hyaluronate injections and conventional sodiumhyaluronate injections in people with Temporomandibular Disorder, run by Hams Hamed Abdelrahman 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 4 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 Oct 2024. 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?
Change in TMJ dysfunction (time frame: Baseline, 1 month, and 3 months). The study lists 2 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 NCT06667791, which also lists 1 linked publication.
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 Oct 2024.