Mandibular ResectionPhase 2NCT06770868
A Novel Alloplastic Patient Specific Temporalis Tendon Enthesis
A Phase 2 study testing Patient specific reconstruction plate for patients suffering from mandibular segmental defects in people with Mandibular Resection, run by Alexandria University at 1 site in Egypt.
Trial summary
Mandibular reconstruction of segmental defects is an arduous surgical procedure that requires an utmost degree of surgical fidelity. Whether primary bone reconstruction is feasible or not, alloplastic bridging between the remaining bone stumps is mandatory to achieve functional, aesthetic, and symmetrical demands of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mandibular Resection
- What is being tested?
- Patient specific reconstruction plate for patients suffering from mandibular segmental defects
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2023to 18 May 2024
- Phase
- Phase 2
- 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 with mandibular lesion that require segmental resection.
- Patients required coronoid processes resection within the safety margin of the lesion.
- Brown Class I cases with preservation of the condyle process and no need for alloplastic TMJ replacement.
- Complaisant patient that is able to complete at least 1 year follow up.
Who cannot join
- Composite mandibular defect.
- Malignant lesions that required postoperative adjunctive therapies (CT or RT).
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry, Alexandria University
Alexandria, Alexandria Governorate
About this study
Official title: A Novel Alloplastic Patient Specific Temporalis Tendon Enthesis for Mandibular Resection with Coronoidectomy
Mandibular reconstruction of segmental defects is an arduous surgical procedure that requires an utmost degree of surgical fidelity. Whether primary bone reconstruction is feasible or not, alloplastic bridging between the remaining bone stumps is mandatory to achieve functional, aesthetic, and symmetrical demands of the lower third of the face. Mandibular reconstructive surgery should be directed toward the maintains of the normal orthognathic centric condylar position, mandibular kinematics, and muscles of mastication function. Mandibular resection with coronoid removal cause imbalance in the attachment of one of the large muscles of mastication, the temporalis muscle. The use of computer-aided surgery allowed the creation of custom made fixation plates with a plethora of advantages over the conventional plates.
the study aims to introduce a novel plate design, which creates an enthsis for the reattachment of the temporalis muscle tendon.
- Conditions
- Mandibular Resection
- Being tested
- Patient specific reconstruction plate for patients suffering from mandibular segmental defects
- Keywords
- mandibular resection, coronoid, computer assisted, computer-aided design,, computer-aided manufacturing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient specific reconstruction plate for patients suffering from mandibular segmental defectsDevice
Patients with mandibular segmental defect including coronoidectomy managed with patient specific reconstruction plate with custom made temporalis tendon enthesis
| Study group | Role | What they receive |
|---|---|---|
| Patient specific reconstruction plate for patients suffering from mandibular segmental defects | Experimental | Patients with mandibular segmental defect including coronoidectomy managed with patient specific reconstruction plate with custom made temporalis tendon enthesis Receives: Device: Patient specific reconstruction plate for patients suffering from mandibular segmental defects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mandibular Kinematics assessment
range of mandibular excursions were recorded preoperatively (T0) and at 1-postopertive week (T1), 1-postoperative month (T2), 4-postoperative month (T3), 6- postoperative month (T4).
Measured: 6 months
Secondary outcomes (1)
Postoperative temporalis muscle activity
surface-Electromyogram (sEMG) was used by the patients during their maximum voluntary clenching by placement of two channels on the bilateral temporalis muscles
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start1 Feb 2023
- Primary completion1 Feb 2024
- Study completion18 May 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 Mandibular ResectionStudies of the same condition, open and under way.
- More trials run by Alexandria 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 2
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- mandibular resection with coronoidectomy managed with patient specific reconstruction plate with custom made temporalis tendon enthesis
- Masking
- None (open label)
- Enrolment
- 5 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
- NCT06770868
- Sponsor's protocol ID
- 0118-21/24
- Status last verified
- Dec 2024
- First submitted
- 21 Dec 2024
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Alryess AM, Marei HW, Abdel-Naby HMA, Abdelrahman HH, Al-Mahalawy H, El-Mahallawy Y. A Novel Alloplastic Patient-Specific Temporalis Tendon Enthesis for Mandibular Resection With Coronoidectomy: A Case Series. J Oral Rehabil. 2026 Jun 14. doi: 10.1111/joor.70238. Online ahead of print.
PubMed 42290023
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Alloplastic Patient Specific Temporalis Tendon Enthesis for Mandibular Resection with Coronoidectomy
- ClinicalTrials.gov ID
- NCT06770868
- Acronym / sponsor ID
- 0118-21/24
- Conditions
- Mandibular Resection
- Keywords
- mandibular resection, coronoid, computer assisted, computer-aided design,, computer-aided manufacturing
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 18 May 2024 (actual)
- First posted
- 13 Jan 2025 (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.
Mandibular reconstruction of segmental defects is an arduous surgical procedure that requires an utmost degree of surgical fidelity. Whether primary bone reconstruction is feasible or not, alloplastic bridging between the remaining bone stumps is mandatory to achieve functional, aesthetic, and symmetrical demands of the lower third of the face. Mandibular reconstructive surgery should be directed toward the maintains of the normal orthognathic centric condylar position, mandibular kinematics, and muscles of mastication function. Mandibular resection with coronoid removal cause imbalance in the attachment of one of the large muscles of mastication, the temporalis muscle. The use of computer-aided surgery allowed the creation of custom made fixation plates with a plethora of advantages over the conventional plates.
the study aims to introduce a novel plate design, which creates an enthsis for the reattachment of the temporalis muscle tendon.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- mandibular resection with coronoidectomy managed with patient specific reconstruction plate with custom made temporalis tendon enthesis
| Arm | Type | Receives |
|---|---|---|
| Patient specific reconstruction plate for patients suffering from mandibular segmental defects | Experimental | Device: Patient specific reconstruction plate for patients suffering from mandibular segmental defectsPatients with mandibular segmental defect including coronoidectomy managed with patient specific reconstruction plate with custom made temporalis tendon enthesis |
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 with mandibular lesion that require segmental resection.
- Patients required coronoid processes resection within the safety margin of the lesion.
- Brown Class I cases with preservation of the condyle process and no need for alloplastic TMJ replacement.
- Complaisant patient that is able to complete at least 1 year follow up.
Key exclusion criteria (2 listed)
- Composite mandibular defect.
- Malignant lesions that required postoperative adjunctive therapies (CT or RT).
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 reconstruction plate for patients suffering from mandibular segmental defectsPatients with mandibular segmental defect including coronoidectomy managed with patient specific reconstruction plate with custom made temporalis tendon enthesis | Device | Patient specific reconstruction plate for patients suffering from mandibular segmental defects |
Primary outcome
Mandibular Kinematics assessment
Time frame: 6 months
range of mandibular excursions were recorded preoperatively (T0) and at 1-postopertive week (T1), 1-postoperative month (T2), 4-postoperative month (T3), 6- postoperative month (T4).
1 secondary outcome
Postoperative temporalis muscle activity
Time frame: 6 months
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 13 Jan 2025.
- Derived from this study: PubMed 42290023Alryess AM, Marei HW, Abdel-Naby HMA, Abdelrahman HH, Al-Mahalawy H, El-Mahallawy Y. A Novel Alloplastic Patient-Specific Temporalis Tendon Enthesis for Mandibular Resection With Coronoidectomy: A Case Series. J Oral Rehabil. 2026 Jun 14. doi: 10.1111/joor.70238. Online ahead of print.
- Individual participant dataSharing planned: Yes. 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
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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 Phase 2 study testing Patient specific reconstruction plate for patients suffering from mandibular segmental defects in people with Mandibular Resection, 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 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 13 Jan 2025. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Mandibular Kinematics assessment (time frame: 6 months). 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 NCT06770868, 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 13 Jan 2025.