Edentulous Alveolar Ridge AtrophyNCT07014527
Assessment of the Accuracy of Full Digital Workflow in Patient Specific Submerged Subperiosteal Implants: A Case Series Study
A study testing Patient specific subperiosteal implants in people with Edentulous Alveolar Ridge Atrophy and ATROPHYC EDENTULOUS JAW, run by Cairo University at 1 site in Egypt.
Trial summary
custom made subperiosteal implants will be designed using the patients' CT data and will be inserted with the help of a surgical guide and loaded by a screw retained full arch prosthesis. accuracy will be assessed Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Edentulous Alveolar Ridge Atrophy, ATROPHYC EDENTULOUS JAW, Edentulous Maxilla
- What is being tested?
- Patient specific subperiosteal implants
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2025to 1 May 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adults patients with severely atrophic alveolar ridges in both maxilla and mandible.
Who cannot join
- Alveolar bone dimensions that can allow for root form implant placement
Trial locations and contacts
1 site in 1 country.
About this study
custom made subperiosteal implants will be designed using the patients' CT data and will be inserted with the help of a surgical guide and loaded by a screw retained full arch prosthesis. accuracy will be assessed
- Conditions
- Edentulous Alveolar Ridge Atrophy, ATROPHYC EDENTULOUS JAW, Edentulous Maxilla, Edentulous Alveolar Ridge In Mandible
- Being tested
- Patient specific subperiosteal implants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient specific subperiosteal implantsProcedure or surgery
Patient specific subperiosteal implants
| Study group | Role | What they receive |
|---|---|---|
| Computer guided custom made subperiosteal implant treatment | Experimental | Patients will receive a patient specific custom made subperiosteal implant and the accuracy will be assessed Receives: Procedure: Patient specific subperiosteal implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy
accuracy of the position of patient specific subperiosteal implants by superimposition of immediately postoperative CT over the preoperative plan and taking linear measurements (in millimeters)
Measured: immediately postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start1 Jan 2025
- Primary completion1 May 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous Alveolar Ridge AtrophyStudies 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Shawky, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07014527
- Sponsor's protocol ID
- OMFS 2025
- Status last verified
- Jan 2025
- First submitted
- 25 May 2025
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available upon reasonable request from the authors
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Accuracy of Full Digital Workflow in Patient Specific Submerged Subperiosteal Implants: A Case Series Study
- ClinicalTrials.gov ID
- NCT07014527
- Acronym / sponsor ID
- OMFS 2025
- Conditions
- Edentulous Alveolar Ridge Atrophy, ATROPHYC EDENTULOUS JAW, Edentulous Maxilla, Edentulous Alveolar Ridge In Mandible
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 11 Jun 2025 (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.
custom made subperiosteal implants will be designed using the patients' CT data and will be inserted with the help of a surgical guide and loaded by a screw retained full arch prosthesis. accuracy will be assessed
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Computer guided custom made subperiosteal implant treatment | Experimental | Procedure: Patient specific subperiosteal implantsPatients will receive a patient specific custom made subperiosteal implant and the accuracy will be assessed |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Adults patients with severely atrophic alveolar ridges in both maxilla and mandible.
Key exclusion criteria (1 listed)
- Alveolar bone dimensions that can allow for root form implant placement
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 |
|---|---|---|
| Patient specific subperiosteal implantsPatient specific subperiosteal implants | Procedure or surgery | Computer guided custom made subperiosteal implant treatment |
Primary outcome
Accuracy
Time frame: immediately postoperative
accuracy of the position of patient specific subperiosteal implants by superimposition of immediately postoperative CT over the preoperative plan and taking linear measurements (in millimeters)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- Individual participant dataSharing planned: Yes. Data will be available upon reasonable request from the authors
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient specific subperiosteal implants in people with Edentulous Alveolar Ridge Atrophy and ATROPHYC EDENTULOUS JAW, run by Cairo 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 11 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy (time frame: immediately postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jun 2025.