A Novel Alloplastic Patient Specific Temporalis Tendon Enthesis

NCT ID: NCT06770868

Last Updated: 2025-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2024-05-18

Brief 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 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Patient specific reconstruction plate for patients suffering from mandibular segmental defects

Patients with mandibular segmental defect including coronoidectomy managed with patient specific reconstruction plate with custom made temporalis tendon enthesis

Group Type: EXPERIMENTAL

Patient specific reconstruction plate for patients suffering from mandibular segmental defects

Intervention Type: DEVICE

Patients with mandibular segmental defect including coronoidectomy managed with patient specific reconstruction plate with custom made temporalis tendon enthesis

Interventions

Patient specific reconstruction plate for patients suffering from mandibular segmental defects

Patients with mandibular segmental defect including coronoidectomy managed with patient specific reconstruction plate with custom made temporalis tendon enthesis

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• Composite mandibular defect.
• Malignant lesions that required postoperative adjunctive therapies (CT or RT).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alexandria University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Faculty of Dentistry, Alexandria University

Alexandria, Alexandria Governorate, Egypt

Countries

Egypt

Other Identifiers

0118-21/24

Identifier Type: -

Identifier Source: org_study_id