Mandibular Resection
Conditions
Keywords
mandibular resection, coronoid, computer assisted, computer-aided design,, computer-aided manufacturing
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.
Interventions
DEVICEPatient 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
Sponsors
Alexandria University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
mandibular resection with coronoidectomy managed with patient specific reconstruction plate with custom made temporalis tendon enthesis
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Egypt
Outcome results
None listed