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OpenTrials
Completed

NCT Number: NCT06770868

A Novel Alloplastic Patient Specific Temporalis Tendon Enthesis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Faculty of Dentistry, Alexandria University

Alexandria, Alexandria Governorate, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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

Primary outcomes

  1. 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).

Secondary outcomes

  1. Postoperative temporalis muscle activity

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

A Novel Alloplastic Patient Specific Temporalis Tendon Enthesis for Mandibular Resection with Coronoidectomy

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 13, 2025
Registry last updated
Jan 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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