Validity of PEEK PSI Containing Autogenous Bone Graft for Maxillary Reconstruction Following Lesion Enucleation

Study Overview
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Brief Summary
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Surgical ablation of large maxillary cysts usually results in considerable hard and soft tissue deficits that ultimately affect the final esthetic and functional outcomes. Reconstruction of such defects; whether primarily or secondarily; offers much better long-term outcomes. However, primary bony reconstruction becomes potentially complicated in many cases of such large cysts encroaching or involving the maxillary sinus where a communication with the maxillary sinus lining may be unavoidable. Reconstruction of such defects can be accomplished using either vascularized or; more commonly; non-vascularized autogenous bone grafts. Different bone substitutes remain to be another viable option. The simultaneous use of titanium meshes provides physical three-dimensional support for the bone graft contained within as well as the overlying soft tissues. However, the drawbacks of titanium meshes in such defects remain to be mainly the difficulty in adequately shaping the mesh and the lack of proper isolation of the mesh contents from the maxillary sinus cavity.

Official Title
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Validity of PEEK PSI Containing Autogenous Bone Graft for Maxillary Reconstruction Following Lesion Enucleation

Conditions
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Maxillary Cyst

Intervention / Treatment
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* Device: Poly Ether Ether Ketone PSI (patient specific implant).


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age of patients from 15 to 60 years old. Patients with unilateral maxillary lesion encroaching maxillary sinus. Dentulous or edentulous patients. Patients should be free from any systemic disease that may affect normal healing of bone and predictable outcome. Exclusion Criteria: Patients with systemic diseases as history of radiation therapy or chemotherapy, hematological disorders, neuromotor disorders and autoimmune diseases (may affect normal healing). Patients with bilateral maxillary lesions. Children under 15 years old.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PEEK patient specific implant<br>this PEEK (poly ether ether ketone) Patient Specific Implant containing autogenous bone graft is used in reconstruction of the bone and the original volume of maxillary sinus accurately (in terms of clinical and radiographic parameters). | Device: Poly Ether Ether Ketone PSI (patient specific implant).<br>* reconstruction of the bone and the original volume of maxillary sinus accurately (in terms of clinical and radiographic parameters).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oral health related quality of life | OHIP-49 questionaire | 4 months |