Maxillary CystNCT03265795
Validity of PEEK PSI Containing Autogenous Bone Graft for Maxillary Reconstruction Following Lesion Enucleation
A study testing Poly Ether Ether Ketone PSI (patient specific implant). in people with Maxillary Cyst, run by Cairo University.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 60 years
- Conditions the study is for
- Maxillary Cyst
- What is being tested?
- Poly Ether Ether Ketone PSI (patient specific implant).
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2018to 1 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
Maha Hakam contact
About this study
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
- Being tested
- Poly Ether Ether Ketone PSI (patient specific implant).
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: Poly Ether Ether Ketone PSI (patient specific implant). |
What is being measured
The primary outcome is the main question the study is designed to answer.
oral health related quality of life
OHIP-49 questionaire
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study start1 Jan 2018 (estimated)
- Primary completion1 Mar 2018 (estimated)
- Study completion1 Jul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Maxillary CystStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Zain, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03265795
- Sponsor's protocol ID
- maxillary reconstruction
- Status last verified
- Aug 2017
- First submitted
- 27 Aug 2017
- Last updated
- 30 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 12409759Eckardt 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 16327572Lethaus 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity of PEEK PSI Containing Autogenous Bone Graft for Maxillary Reconstruction Following Lesion Enucleation
- ClinicalTrials.gov ID
- NCT03265795
- Acronym / sponsor ID
- maxillary reconstruction
- Conditions
- Maxillary Cyst
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (estimated)
- Primary completion
- 1 Mar 2018 (estimated)
- Study completion
- 1 Jul 2018 (estimated)
- First posted
- 29 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PEEK patient specific implant | Experimental | Device: Poly Ether Ether Ketone PSI (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). |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Device | PEEK patient specific implant |
Primary outcome
oral health related quality of life
Time frame: 4 months
OHIP-49 questionaire
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2017.
- Background: PubMed 12409759Gellrich 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.
- Background: PubMed 16327572Eckardt 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.
- Background: PubMed 20642821Lethaus 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maha Hakam contact
Questions about this trial
What is this clinical trial studying?
A study testing Poly Ether Ether Ketone PSI (patient specific implant). in people with Maxillary Cyst, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Zain, DDS (00201003363809, m_zain_89@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oral health related quality of life (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03265795, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2017.