A Novel Alloplastic Patient Specific Temporalis Tendon Enthesis

Phase 2

Completed

• Conditions: Mandibular Resection

• Registration Number: NCT06770868
• Lead Sponsor: Alexandria University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-01
• Primary Completion: 2024-02-01
• Study Completion: 2024-05-18
• Status Verified: 2024-12
• Study First Submitted: 2024-12-21
• Study First Submitted QC: 2025-01-07
• Last Update Submitted: 2025-01-07
• Study First Posted: 2025-01-13
• Last Update Posted: 2025-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Mandibular Kinematics assessment	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).

Secondary Outcome Measures

Name	Time	Method
Postoperative temporalis muscle activity	6 months	surface-Electromyogram (sEMG) was used by the patients during their maximum voluntary clenching by placement of two channels on the bilateral temporalis muscles

Trial Locations

Locations (1)

Faculty of Dentistry, Alexandria University; 🇪🇬 Alexandria, Egypt