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

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ClinicalTrials.gov Identifier: NCT03265795
Recruitment Status : Not yet recruiting
First Posted : August 29, 2017
Last Update Posted : August 30, 2017
Sponsor:
Information provided by (Responsible Party):
Mohammed Zain, 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.


Condition or disease Intervention/treatment Phase
Maxillary Cyst Device: Poly Ether Ether Ketone PSI (patient specific implant). Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Validity of PEEK PSI Containing Autogenous Bone Graft for Maxillary Reconstruction Following Lesion Enucleation
Estimated Study Start Date : January 1, 2018
Estimated Primary Completion Date : March 1, 2018
Estimated Study Completion Date : July 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PEEK 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).
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).




Primary Outcome Measures :
  1. oral health related quality of life [ Time Frame: 4 months ]
    OHIP-49 questionaire



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Ages Eligible for Study:   15 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03265795


Contacts
Contact: Mohamed Zain, DDS 00201003363809 m_zain_89@hotmail.com
Contact: Maha Hakam

Sponsors and Collaborators
Cairo University

Publications:
Responsible Party: Mohammed Zain, internal resident at oral and maxillofacial department, Cairo University
ClinicalTrials.gov Identifier: NCT03265795     History of Changes
Other Study ID Numbers: maxillary reconstruction
First Posted: August 29, 2017    Key Record Dates
Last Update Posted: August 30, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Ether
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs