Validity of PEEK PSI Containing Autogenous Bone Graft for Maxillary Reconstruction Following Lesion Enucleation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03265795|
Recruitment Status : Not yet recruiting
First Posted : August 29, 2017
Last Update Posted : August 30, 2017
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)|
|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|
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).
- oral health related quality of life [ Time Frame: 4 months ]OHIP-49 questionaire
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
|Contact: Mohamed Zain, DDSfirstname.lastname@example.org|
|Contact: Maha Hakam|