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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03265795
Enrollment
8
Registered
2017-08-29
Start date
2018-01-01
Completion date
2018-07-01
Last updated
2017-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maxillary Cyst

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.

Interventions

DEVICEPoly 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

Cairo University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
15 Years to 60 Years
Healthy volunteers
No

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.

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.

Design outcomes

Primary

MeasureTime frameDescription
oral health related quality of life4 monthsOHIP-49 questionaire

Contacts

Primary ContactMohamed Zain, DDS
m_zain_89@hotmail.com00201003363809
Backup ContactMaha Hakam

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026