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

NCT03265795 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2017-08-30

No results posted yet for this study

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.

Conditions

  • Maxillary Cyst

Interventions

DEVICE

Poly Ether Ether Ketone PSI (patient specific implant).

reconstruction of the bone and the original volume of maxillary sinus accurately (in terms of clinical and radiographic parameters).

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
15 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2018-03-01
Completion
2018-07-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03265795 on ClinicalTrials.gov