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

NCT03265795 | Unknown

• 1 other identifier: maxillary reconstruction
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Maxillary Cyst

Outcome Measures

Primary Outcomes (1)

• oral health related quality of life

  OHIP-49 questionaire

  4 months

Study Arms (1)

PEEK patient specific implant

EXPERIMENTAL

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).

Interventions

Poly Ether Ether Ketone PSI (patient specific implant). DEVICE

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

PEEK patient specific implant

Eligibility Criteria

• Age: 15 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Related Publications (3)

• Gellrich NC, Schramm A, Hammer B, Rojas S, Cufi D, Lagreze W, Schmelzeisen R. Computer-assisted secondary reconstruction of unilateral posttraumatic orbital deformity. Plast Reconstr Surg. 2002 Nov;110(6):1417-29. doi: 10.1097/01.PRS.0000029807.35391.E5.

  PMID: 12409759 BACKGROUND

• Eckardt A, Swennen GR. Virtual planning of composite mandibular reconstruction with free fibula bone graft. J Craniofac Surg. 2005 Nov;16(6):1137-40. doi: 10.1097/01.scs.0000186306.32042.96.

  PMID: 16327572 BACKGROUND

• Lethaus B, Kessler P, Boeckman R, Poort LJ, Tolba R. Reconstruction of a maxillary defect with a fibula graft and titanium mesh using CAD/CAM techniques. Head Face Med. 2010 Jul 19;6:16. doi: 10.1186/1746-160X-6-16.

  PMID: 20642821 BACKGROUND

Central Study Contacts

Mohamed Zain, DDS

CONTACT

00201003363809; m_zain_89@hotmail.com

Maha Hakam

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: internal resident at oral and maxillofacial department

Study Record Dates

• First Submitted: August 27, 2017
• First Posted: August 29, 2017
• Study Start: January 1, 2018
• Primary Completion: March 1, 2018
• Study Completion: July 1, 2018
• Last Updated: August 30, 2017

Record last verified: 2017-08