A Novel Alloplastic Patient Specific Temporalis Tendon Enthesis

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.

Study Overview

• Status: Completed
• Conditions: Mandibular Resection
• Intervention / Treatment: Device: Patient specific reconstruction plate for patients suffering from mandibular segmental defects

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Faculty of Dentistry, Alexandria University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 months

Collaborators and Investigators

• Sponsor: Alexandria University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Actual): February 1, 2024
• Study Completion (Actual): May 18, 2024

Study Registration Dates

• First Submitted: December 21, 2024
• First Submitted That Met QC Criteria: January 7, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 7, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: computer assisted; computer-aided manufacturing; mandibular resection; coronoid; computer-aided design,
• Other Study ID Numbers: 0118-21/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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
• IPD Sharing Access Criteria: to any one who required them after deidentification
• IPD Sharing Supporting Information Type: SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No