Bone LossNCT06362057
Biomechanical Effects of Digitally Constructed Subperiosteal Implants
An observational study of Bone Loss, run by Menoufia University at 1 site in Egypt.
Trial summary
Subperiosteal implants were first introduced in 1940 and then used worldwide for the treatment of edentulous maxilla or mandible with advanced bone atrophy. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Bone Loss
- What is being tested?
- Subperiosteal implant framework
- How many people
- 9 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Apr 2024to 27 Jul 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 30 to 70 years
- All sexes
- Adult, Older adult
Study population: This is a three dimentional finite element analysis
Who may be able to join
- A 3D image of an edentulous maxilla bone derived from a computed tomography scan of an adult patient.
- Maxilla with Cawood and Howell class 4 or 5 classification
Who cannot join
- A 2D image of an edentulous maxilla bone
- A non atrophied maxilla
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Mohammed A. El-Sawy
Al Mansurah, 12345
Mohammed A. El-Sawy, PhD, 161314522, Dr_sawy@windowslive.com
PhD
About this study
Official title: Biomechanical Effects of Digitally Constructed Subperiosteal Implants From Different Materials With Different Prosthetic Superstructures on Atrophied Maxilla: A Finite Element Analysis
Subperiosteal implants were first introduced in 1940 and then used worldwide for the treatment of edentulous maxilla or mandible with advanced bone atrophy.
Read the detailed description
With the advancement of digital technology for the fabrication of materials and the emerging of new materials, subperiosteal implants can be fabricated from a wide variety of materials, and there is a lack of evidence regarding which material could be suitable.
- Conditions
- Bone Loss
- Being tested
- Subperiosteal implant framework
- Keywords
- Polyetherketoneketone, Titanium, Polyethereetherketone
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subperiosteal implant frameworkOther
A 3D image of an edentulous maxilla bone will be derived from a computed tomography scan of an adult patient and saved as "stl" data. The solid geometry of the maxilla, including the cortical and spongious bone, was rebuilt from the "stl" data into the Digital Imaging and Communications in Medicine (DICOM) format with 3D-Doctor (Able Software Corp., MA, USA).
With the Boolean method, force loading will be achieved between prosthetic parts, subperiosteal implant screws and bone tissues
| Study group | Role | What they receive |
|---|---|---|
| Titanium framework group | Virtual design for Titanium subperiosteal framework group on atrophied maxilla. Receives: Other: Subperiosteal implant framework | |
| PEEK framework group | Virtual design for PEEK subperiosteal framework group on atrophied maxilla. Receives: Other: Subperiosteal implant framework | |
| PEKK framework group | Virtual design for PEKK subperiosteal framework group on atrophied maxilla. Receives: Other: Subperiosteal implant framework |
What is being measured
The primary outcome is the main question the study is designed to answer.
bone loss under the implants
amount of bone loss which appears on a modeling process, The modeling process will be completed using a three-dimensional modeling software. A three-dimensional mesh consisting of 556,365 nodes and 2972,897 elements with VRMesh Studio (VirtualGrid Inc, Bellevue City, WA, USA) will used in the program.
Measured: 10-15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start4 Apr 2024
- Primary completion20 May 2025 (estimated)
- Study completion27 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bone LossStudies of the same condition, open and under way.
- More trials run by Menoufia 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed El-Sawy, Menoufia University
- Investigators
- Mohammed A. El-Sawy, PhD, Study chair, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06362057
- Sponsor's protocol ID
- 001-130125-017
- Status last verified
- Mar 2025
- First submitted
- 8 Apr 2024
- Last updated
- 27 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The IPD is upon request from the corresponding author
Publications
El-Sawy MA, El-Khatib B, Borg HS, Khater MT. Biomechanical effects of digitally constructed titanium, modified polyetheretherketone, and polyetherketoneketone subperiosteal implants on atrophied maxilla: a finite element analysis. BMC Oral Health. 2025 Jul 10;25(1):1142. doi: 10.1186/s12903-025-06426-z.
PubMed 40640731
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomechanical Effects of Digitally Constructed Subperiosteal Implants From Different Materials With Different Prosthetic Superstructures on Atrophied Maxilla: A Finite Element Analysis
- ClinicalTrials.gov ID
- NCT06362057
- Acronym / sponsor ID
- 001-130125-017
- Conditions
- Bone Loss
- Keywords
- Polyetherketoneketone, Titanium, Polyethereetherketone
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 4 Apr 2024 (actual)
- Primary completion
- 20 May 2025 (estimated)
- Study completion
- 27 Jul 2025 (estimated)
- First posted
- 12 Apr 2024 (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.
Subperiosteal implants were first introduced in 1940 and then used worldwide for the treatment of edentulous maxilla or mandible with advanced bone atrophy.
Detailed description
With the advancement of digital technology for the fabrication of materials and the emerging of new materials, subperiosteal implants can be fabricated from a wide variety of materials, and there is a lack of evidence regarding which material could be suitable.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Titanium framework group | – | Other: Subperiosteal implant frameworkVirtual design for Titanium subperiosteal framework group on atrophied maxilla. |
| PEEK framework group | – | Other: Subperiosteal implant frameworkVirtual design for PEEK subperiosteal framework group on atrophied maxilla. |
| PEKK framework group | – | Other: Subperiosteal implant frameworkVirtual design for PEKK subperiosteal framework group on atrophied maxilla. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This is a three dimentional finite element analysis
Key inclusion criteria (2 listed)
- A 3D image of an edentulous maxilla bone derived from a computed tomography scan of an adult patient.
- Maxilla with Cawood and Howell class 4 or 5 classification
Key exclusion criteria (2 listed)
- A 2D image of an edentulous maxilla bone
- A non atrophied maxilla
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 |
|---|---|---|
| Subperiosteal implant frameworkA 3D image of an edentulous maxilla bone will be derived from a computed tomography scan of an adult patient and saved as "stl" data. The solid geometry of the maxilla, including the cortical and spongious bone, was rebuilt from the "stl" data into the Digital Imaging and Communications in Medicine (DICOM) format with 3D-Doctor (Able Software Corp., MA, USA). With the Boolean method, force loading will be achieved between prosthetic parts, subperiosteal implant screws and bone tissues | Other | PEEK framework group, PEKK framework group, Titanium framework group |
Primary outcome
bone loss under the implants
Time frame: 10-15 years
amount of bone loss which appears on a modeling process, The modeling process will be completed using a three-dimensional modeling software. A three-dimensional mesh consisting of 556,365 nodes and 2972,897 elements with VRMesh Studio (VirtualGrid Inc, Bellevue City, WA, USA) will used in the program.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Derived from this study: PubMed 40640731El-Sawy MA, El-Khatib B, Borg HS, Khater MT. Biomechanical effects of digitally constructed titanium, modified polyetheretherketone, and polyetherketoneketone subperiosteal implants on atrophied maxilla: a finite element analysis. BMC Oral Health. 2025 Jul 10;25(1):1142. doi: 10.1186/s12903-025-06426-z.
- Individual participant dataSharing planned: No. The IPD is upon request from the corresponding author
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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.
Mohammed A. El-Sawy, PhD study chair
Menoufia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Loss, run by Menoufia University at 1 site in Egypt.
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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohammed A. El-Sawy, PhD (161314522, Dr_sawy@windowslive.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bone loss under the implants (time frame: 10-15 years). 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 NCT06362057, which also lists 1 linked publication.
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 27 Mar 2025.