Temporomandibular Joint AnkylosisNCT07320911
Patient-Specific Guides for Gap Pediatric Arthroplasty
A study testing Patient-Specific Narrow-Slit Osteotomy Guides in people with Temporomandibular Joint Ankylosis, run by Alexandria University at 1 site in Egypt.
Trial summary
To date, few reports have combined patient-specific guides with piezoelectric devices for gap arthroplasty in children. This study evaluates the feasibility, accuracy, and early outcomes of this approach, hypothesizing that the combination of narrow-slit surgical guides and piezoelectric osteotomy provides safe and… Read more about this study
- Who is it for?
- Ages Up to 15 years
- Conditions the study is for
- Temporomandibular Joint Ankylosis
- What is being tested?
- Patient-Specific Narrow-Slit Osteotomy Guides
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Up to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- patient with TMJ ankylosis.
- less than 15 years old at the time of surgery
Who cannot join
- Fibrous ankylosis without bony involvement
- Associated craniofacial syndromes
- Patients with systemic conditions contraindicating surgery
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry, Alexandria University
Alexandria, Alexandria Governorate, 21523
About this study
Official title: Patient-Specific Narrow-Slit Osteotomy Guides for Gap Arthroplasty in Pediatric TMJ Ankylosis
To date, few reports have combined patient-specific guides with piezoelectric devices for gap arthroplasty in children. This study evaluates the feasibility, accuracy, and early outcomes of this approach, hypothesizing that the combination of narrow-slit surgical guides and piezoelectric osteotomy provides safe and reproducible results in pediatric TMJ ankylosis.
Read the detailed description
A prospective pilot study was conducted on [n] children (mean age [x] years) with TMJ ankylosis. Virtual surgical planning and CAD/CAM fabrication were used to design patient-specific guides with narrower osteotomy slits (width [x] mm) to allow precise bone removal and improved condylar fit. Preoperative and postoperative CT scans were superimposed to measure the accuracy of gap creation. Functional outcomes included maximal interincisal opening (MIO) at 1, 3, and 6 months, and complications.
- Conditions
- Temporomandibular Joint Ankylosis
- Being tested
- Patient-Specific Narrow-Slit Osteotomy Guides
- Keywords
- TMJ ankylosis, pediatrics, gap arthroplasty, CAD/CAM, surgical guide
- Medical subject headings
- Temporomandibular ankylosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient-Specific Narrow-Slit Osteotomy GuidesDevice
Patient-Specific Narrow-Slit Osteotomy Guides for gap arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| Patient-Specific Narrow-Slit Osteotomy Guides for Gap Arthroplasty | Experimental | Pediatric patient with TMJ Ankylosis managed with Patient-Specific Narrow-Slit Osteotomy Guides Receives: Device: Patient-Specific Narrow-Slit Osteotomy Guides |
What is being measured
The primary outcome is the main question the study is designed to answer.
accuracy of the guide
Follow-up imaging was performed 1 week postoperatively using computed tomography (CT). Digital superimposition of the preoperative virtual plan and postoperative CT scans was carried out to assess the accuracy of osteotomy execution.
Measured: 1 week
Secondary outcomes (1)
mouth opening
inter-arch mouth opening assessment
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start1 Jan 2025
- Primary completion30 Jul 2025
- Study completion31 Dec 2025 (estimated)
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 Joint AnkylosisStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07320911
- Sponsor's protocol ID
- 20-12-25/Artho-Tmj
- Status last verified
- Dec 2025
- First submitted
- 20 Dec 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data will be de-identified to protect the participant data. patients signed an informed consent for the use of their medical records and data for study.
Publications
El-Mahallawy Y, Abdelmoneim NM, Marei HW, Abdelhamed IM. Patient-specific arthroplasty guide in paediatric temporomandibular joint ankylosis management. An accuracy-based case series. Maxillofac Plast Reconstr Surg. 2026 Jul 6;48(1):18. doi: 10.1186/s40902-026-00518-8.
PubMed 42402546
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Specific Narrow-Slit Osteotomy Guides for Gap Arthroplasty in Pediatric TMJ Ankylosis
- ClinicalTrials.gov ID
- NCT07320911
- Acronym / sponsor ID
- 20-12-25/Artho-Tmj
- Conditions
- Temporomandibular Joint Ankylosis
- Keywords
- TMJ ankylosis, pediatrics, gap arthroplasty, CAD/CAM, surgical guide
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 6 Jan 2026 (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.
To date, few reports have combined patient-specific guides with piezoelectric devices for gap arthroplasty in children. This study evaluates the feasibility, accuracy, and early outcomes of this approach, hypothesizing that the combination of narrow-slit surgical guides and piezoelectric osteotomy provides safe and reproducible results in pediatric TMJ ankylosis.
Detailed description
A prospective pilot study was conducted on [n] children (mean age [x] years) with TMJ ankylosis. Virtual surgical planning and CAD/CAM fabrication were used to design patient-specific guides with narrower osteotomy slits (width [x] mm) to allow precise bone removal and improved condylar fit. Preoperative and postoperative CT scans were superimposed to measure the accuracy of gap creation. Functional outcomes included maximal interincisal opening (MIO) at 1, 3, and 6 months, and complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient-Specific Narrow-Slit Osteotomy Guides for Gap Arthroplasty | Experimental | Device: Patient-Specific Narrow-Slit Osteotomy GuidesPediatric patient with TMJ Ankylosis managed with Patient-Specific Narrow-Slit Osteotomy Guides |
Who may qualify
- Ages
- Up to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- patient with TMJ ankylosis.
- less than 15 years old at the time of surgery
Key exclusion criteria (3 listed)
- Fibrous ankylosis without bony involvement
- Associated craniofacial syndromes
- Patients with systemic conditions contraindicating surgery
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 |
|---|---|---|
| Patient-Specific Narrow-Slit Osteotomy GuidesPatient-Specific Narrow-Slit Osteotomy Guides for gap arthroplasty | Device | Patient-Specific Narrow-Slit Osteotomy Guides for Gap Arthroplasty |
Primary outcome
accuracy of the guide
Time frame: 1 week
Follow-up imaging was performed 1 week postoperatively using computed tomography (CT). Digital superimposition of the preoperative virtual plan and postoperative CT scans was carried out to assess the accuracy of osteotomy execution.
1 secondary outcome
mouth opening
Time frame: 2 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Derived from this study: PubMed 42402546El-Mahallawy Y, Abdelmoneim NM, Marei HW, Abdelhamed IM. Patient-specific arthroplasty guide in paediatric temporomandibular joint ankylosis management. An accuracy-based case series. Maxillofac Plast Reconstr Surg. 2026 Jul 6;48(1):18. doi: 10.1186/s40902-026-00518-8.
- Individual participant dataSharing planned: No. All data will be de-identified to protect the participant data. patients signed an informed consent for the use of their medical records and data for study.
Related trials for Temporomandibular Joint Ankylosis
RecruitingObservational study
Alloplastic Total Temporomandibular Joint (TMJ) Replacement Registry
Temporomandibular Joint Disorders
RecruitingObservational study
Virtual Planning of Total Temporomandibular Joint Replacement
Temporomandibular Disorders (TMD), Temporomandibular Joint Ankylosis
Not yet recruitingObservational study
Clinical, Microbial and Tissue-based Characterization of Patients Treated for Severe Temporomandibular Joint Pathology
TMJ Disorder, Ankylosis
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 Patient-Specific Narrow-Slit Osteotomy Guides in people with Temporomandibular Joint Ankylosis, run by Alexandria 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 3 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: under way, not looking for participants, as of the sponsor's last update on 6 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
accuracy of the guide (time frame: 1 week). 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 NCT07320911, 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 6 Jan 2026.