A Novel Alloplastic Patient Specific Temporalis Tendon Enthesis

NCT06770868 | Completed Phase 2

• 1 other identifier: 0118-21/24
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Keywords

mandibular resection; coronoid; computer assisted; computer-aided design,; computer-aided manufacturing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Postoperative temporalis muscle activity

  6 months

Study Arms (1)

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

Device: Patient specific reconstruction plate for patients suffering from mandibular segmental defects

Interventions

Patient specific reconstruction plate for patients suffering from mandibular segmental defects DEVICE

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

Patient specific reconstruction plate for patients suffering from mandibular segmental defects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, Alexandria Governorate, Egypt

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: mandibular resection with coronoidectomy managed with patient specific reconstruction plate with custom made temporalis tendon enthesis

Study Record Dates

• First Submitted: December 21, 2024
• First Posted: January 13, 2025
• Study Start: February 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: May 18, 2024
• Last Updated: January 13, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Access Criteria: to any one who required them after deidentification

Locations

EG (1)