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

Not Applicable

• Conditions: Maxillary Cyst
• Interventions: Device: Poly Ether Ether Ketone PSI (patient specific implant).

• Registration Number: NCT03265795
• Lead Sponsor: Cairo University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-08
• Study First Submitted: 2017-08-27
• Study First Submitted QC: 2017-08-27
• Study First Posted: 2017-08-29
• Last Update Submitted: 2017-08-29
• Last Update Posted: 2017-08-30
• Study Start: 2018-01-01
• Primary Completion: 2018-03-01
• Study Completion: 2018-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

1. Age of patients from 15 to 60 years old.
2. Patients with unilateral maxillary lesion encroaching maxillary sinus.
3. Dentulous or edentulous patients.
4. Patients should be free from any systemic disease that may affect normal healing of bone and predictable outcome.

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Exclusion Criteria

1. Patients with systemic diseases as history of radiation therapy or chemotherapy, hematological disorders, neuromotor disorders and autoimmune diseases (may affect normal healing).
2. Patients with bilateral maxillary lesions.
3. Children under 15 years old.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PEEK patient specific implant	Poly Ether Ether Ketone PSI (patient specific implant).	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).

Primary Outcome Measures

Name	Time	Method
oral health related quality of life	4 months	OHIP-49 questionaire