TMJ DisorderTJRNCT07643259
Virtual Planning of Total TMJ Replacement
A study testing Custom made TMJ in people with TMJ Disorder and Mandibular Deficiency, run by Faculty of Dental Medicine for Girls at 1 site in Egypt.
Trial summary
Virtual Planning of Total TMJ Replacement Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- TMJ Disorder, Mandibular Deficiency, TMJ Ankylosis
- What is being tested?
- Custom made TMJ
- 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 Aug 2023to 24 May 2026
- 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
- Patients have a history of end-stage TMJ disorders.
- Patients with mandibular defects involving the TMJ,developmental abnormalities, trauma and, tumor.
- Patients with failed grafts and alloplastic joint reconstruction.
- Patients with recurrent TMJ ankylosis.
Who cannot join
- Patients with bone disease that can affect stability of the joint.
- Patients with systemic disease, malignancy and immunocompromised patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Accuracy of Virtual Surgical Planning of Total Custom-fit Tempromandibular Joint Replacement
Virtual Planning of Total TMJ Replacement
Read the detailed description
This study were performed on eight patients to evaluate the accuracy of virtual planning of the custom planning alloplastic TMJ replacement surgery
- Conditions
- TMJ Disorder, Mandibular Deficiency, TMJ Ankylosis
- Being tested
- Custom made TMJ
- Keywords
- Virtual Planning, Total TMJ replacement, End Stage TMJ Disorder
- Medical subject headings
- Temporomandibular Joint Disorders, Micrognathism, Temporomandibular ankylosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Custom made TMJDevice
Patients with end stage TMJ disorders, Tumors, Recurrent ankylosis, traumaof failed previous joint reconstruction had TMJ total Replacement using custom made TMJ via Virtual planning
| Study group | Role | What they receive |
|---|---|---|
| Total Joint replacement using Virtual planned custom made joint | Experimental | eight patients had been selected randomly according to the inclusion and exclusion criteria.
All of them were need total joint replacement for their TMJ. Virtually planned custom-made joints were used. The accuracy of the artificial joints then measured. Receives: Device: Custom made TMJ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of the Virtually planned TMJ
superimposition of the postoperative and preoperative instructions using CT calculating Linear deviation (mm) to assess surgical accuracy.
Measured: 3 days postoperative
Secondary outcomes (2)
effect of artificial joint on electromyographic activity of masticatory muscle
was measured using electromyograph. the parameters were measured through recording Muscle activity during maximum voluntary clenching and at rest.
Measured: 3 months following up
occlusal force
occlusal force and distribution during clenching using B scan device. Parameters including Maximum occlusal force (%)
Measured: 3 months following up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start1 Aug 2023
- Primary completion2 Mar 2026
- Study completion24 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TMJ 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
- Not applicable
- Intervention model
- Single group
- Model description
- eight patients were treated with alloplastic TMJ replacement using patient custom made joint designed via virtual surgical planning
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculty of Dental Medicine for Girls
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mahetab Montaser, Faculty of Dental Medicine for Girls
- Investigators
- Mahetab Montaser, PhD Cand., Principal investigator, PHD Candidatesusan Hassan, professor, Study chair, professor of oral and maxillofacial surgerySara Bahaa, Lecturer, Study director, Lecturer of removable prosthesis at Alazhar universitywael shawkat, PHD, Study director, consultant of Oral and Maxillofacial surgery, Nasr city Hospital for Health Insurance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07643259
- Sponsor's protocol ID
- OR SUR-108-2-0
- Acronym
- TJR
- Status last verified
- Jun 2026
- First submitted
- 31 May 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Accuracy of Virtual Surgical Planning of Total Custom-fit Tempromandibular Joint Replacement
- ClinicalTrials.gov ID
- NCT07643259
- Acronym / sponsor ID
- TJR / OR SUR-108-2-0
- Conditions
- TMJ Disorder, Mandibular Deficiency, TMJ Ankylosis
- Keywords
- Virtual Planning, Total TMJ replacement, End Stage TMJ Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Faculty of Dental Medicine for GirlsOther government
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 2 Mar 2026 (actual)
- Study completion
- 24 May 2026 (actual)
- First posted
- 11 Jun 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.
Virtual Planning of Total TMJ Replacement
Detailed description
This study were performed on eight patients to evaluate the accuracy of virtual planning of the custom planning alloplastic TMJ replacement surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- eight patients were treated with alloplastic TMJ replacement using patient custom made joint designed via virtual surgical planning
| Arm | Type | Receives |
|---|---|---|
| Total Joint replacement using Virtual planned custom made joint | Experimental | Device: Custom made TMJeight patients had been selected randomly according to the inclusion and exclusion criteria. All of them were need total joint replacement for their TMJ. Virtually planned custom-made joints were used. The accuracy of the artificial joints then measured. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients have a history of end-stage TMJ disorders.
- Patients with mandibular defects involving the TMJ,developmental abnormalities, trauma and, tumor.
- Patients with failed grafts and alloplastic joint reconstruction.
- Patients with recurrent TMJ ankylosis.
Key exclusion criteria (2 listed)
- Patients with bone disease that can affect stability of the joint.
- Patients with systemic disease, malignancy and immunocompromised patients.
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 |
|---|---|---|
| Custom made TMJPatients with end stage TMJ disorders, Tumors, Recurrent ankylosis, traumaof failed previous joint reconstruction had TMJ total Replacement using custom made TMJ via Virtual planning | Device | Total Joint replacement using Virtual planned custom made joint |
Primary outcome
Accuracy of the Virtually planned TMJ
Time frame: 3 days postoperative
superimposition of the postoperative and preoperative instructions using CT calculating Linear deviation (mm) to assess surgical accuracy.
2 secondary outcomes
effect of artificial joint on electromyographic activity of masticatory muscle
Time frame: 3 months following up
occlusal force
Time frame: 3 months following up
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 11 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for TMJ Disorder
Recruiting
Machine Learning for Evaluating and Diagnosing Temporomandibular Disorders
Temporomandibular Disorders (TMD), TMJ Disorder
Not yet recruiting
Comparison of Conventional,3D Printed and Novel Hybrid Stabilization Splints in the Management of Temporomandibular Joint Disorders
Temporomandibular Disorders (TMDs), Myofascial Pain - Dysfunction Syndrome of TMJ
Enrolling by invitationObservational study
Autologous Exosomes From Platelet-rich Plasma as a Modern Tool of Regenerative Dentistry
Temporomandibular Disorders (TMD), Muscle Pain
Not yet recruiting
Arthroscopic Lysis and Lavage With and Without Intra-articular Injection of Hyaluronic Acid in Patients With DDwoR in TMJ
TMJ Disc Disorder, Temporomandibular Joint Disc Displacement, Without Reduction
Enrolling by invitationObservational study
Bruxism, Pelvic Pain, Erectile Dysfunction, and Anxiety in Young Adult Men
Bruxism, Pelvic Pain
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.
Mahetab Montaser, PhD Cand. principal investigator
PHD Candidate
susan Hassan, professor study chair
professor of oral and maxillofacial surgery
Sara Bahaa, Lecturer study director
Lecturer of removable prosthesis at Alazhar 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 Custom made TMJ in people with TMJ Disorder and Mandibular Deficiency, run by Faculty of Dental Medicine for Girls 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 4 inclusion and 2 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 11 Jun 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?
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?
Accuracy of the Virtually planned TMJ (time frame: 3 days postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jun 2026; AzTrials last refreshed its copy on 27 Oct 2026.