ClinicalTrials.gg
Status unknownNCT03265795Updated Aug 30, 2017

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

An interventional study of Poly Ether Ether Ketone PSI (patient specific implant). in Maxillary Cyst, sponsored by Cairo University. Status unknown. Open to participants aged 15 Years to 60 Years. Per ClinicalTrials.gov, last updated 2017-08-30.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
8
Allocation
Not applicable
Ages
15 Years to 60 Years
Sex
All
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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.

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Conditions studied

  • Maxillary Cyst

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03

In context

Cysts

67 studies on the registry are indexed under Cysts; 16 are open to participants now.

This study's planned enrollment of 8 is below the median of 48 across 40 interventional studies indexed under Cysts.

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Lead sponsor

Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
15 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  1. Patients with systemic diseases as history of radiation therapy or chemotherapy, hematological disorders, neuromotor disorders and diseases (may affect normal healing).
  2. Patients with bilateral maxillary lesions.
  3. Children under 15 years old.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
8 participants (estimated)

Study arms

  • 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).

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).

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What researchers measure

Primary outcomes

  1. oral health related quality of life

    OHIP-49 questionaire

    Time frame: 4 months

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 12409759 ↗
  • 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. PubMed 16327572 ↗
  • 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. PubMed 20642821 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 30, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03265795
Lead sponsor
Cairo University
Responsible party
Mohammed Zain (internal resident at oral and maxillofacial department, Cairo University) — Principal investigator
First posted
Aug 29, 2017
Start date
Jan 1, 2018 (estimated)
Primary completion
Mar 1, 2018 (estimated)
Completion
Jul 1, 2018 (estimated)
Last update
Aug 30, 2017

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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