Edentulous Alveolar RidgeNCT06990360
Accuracy of Computer Guided Implant Placement in Edentulous Mandible A Three-Dimensional In Vitro Study
An observational study of Edentulous Alveolar Ridge and Edentulous Alveolar Ridge In Mandible, run by Eslam Nashaat Saied Ahmed Mohamed at 1 site in Egypt.
Trial summary
Five stryofoam mandibles were included in this study to assess the accuracy of using computer guided surgical stent in placement of dental implants. The mandibles were CBCT scanned and imported to 3diagnosys software to implant planning. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Edentulous Alveolar Ridge, Edentulous Alveolar Ridge In Mandible
- What is being tested?
- CBCT Scanning
- How many people
- 5 participants
- Where
- 1 siteEgypt
- Study dates
- 20 May 2017to 20 Sep 2024
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Five styrofoam mandibles
Who may be able to join
- Five styrofoam mandibles
Who cannot join
- no fractures or pathology
Trial locations and contacts
1 site in 1 country.
About this study
Five stryofoam mandibles were included in this study to assess the accuracy of using computer guided surgical stent in placement of dental implants. The mandibles were CBCT scanned and imported to 3diagnosys software to implant planning. 8 implants were placed in each mandible virtually, 4 anterior implants and 4 posterior implants were placed. The plan was exported as STL file to be imported to the CAD software for designing of the stent. The surgical stent is printed using Micro DGP printer and invision tec e-shell 600 clear resin was used. Stainless steel sleeves were placed in the surgical guide then placed in ethanol 99% to remove the excess monomer.
The stent in placed over the mandible and sequential drilling was done until the desired osteotomies width was approached followed by the placement of the implants. Post-operative CBCT was done for the mandible including the implants to assess the accuracy, angulation and position of the placed implants
- Being tested
- CBCT Scanning
- Keywords
- Computer-guided implant placement, Edentulous mandible, 3D printed surgical guide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBCT ScanningDiagnostic test
The Styrofoam mandibles were scanned using CBCT, which was performed for each mandible pre-operatively, the raw DICOM data set obtained from the CBCT scanning were imported to a special third-party software* for secondary reconstruction.
What is being measured
The primary outcome is the main question the study is designed to answer.
Mesiodistal (MD) Angle
measures in the software in degrees
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start20 May 2017
- Primary completion20 Aug 2024
- Study completion20 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous Alveolar RidgeStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eslam Nashaat Saied Ahmed Mohamed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eslam Nashaat Saied Ahmed Mohamed, Future University in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06990360
- Sponsor's protocol ID
- FUE.REC (13)/12-2017
- Other IDs
- Future University
- Status last verified
- May 2025
- First submitted
- 18 May 2025
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Computer Guided Implant Placement in Edentulous Mandible A Three-Dimensional In Vitro Study
- ClinicalTrials.gov ID
- NCT06990360
- Acronym / sponsor ID
- FUE.REC (13)/12-2017
- Keywords
- Computer-guided implant placement, Edentulous mandible, 3D printed surgical guide
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Eslam Nashaat Saied Ahmed MohamedUniversity, hospital or other
- Study start
- 20 May 2017 (actual)
- Primary completion
- 20 Aug 2024 (actual)
- Study completion
- 20 Sep 2024 (actual)
- First posted
- 25 May 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.
Five stryofoam mandibles were included in this study to assess the accuracy of using computer guided surgical stent in placement of dental implants. The mandibles were CBCT scanned and imported to 3diagnosys software to implant planning. 8 implants were placed in each mandible virtually, 4 anterior implants and 4 posterior implants were placed. The plan was exported as STL file to be imported to the CAD software for designing of the stent. The surgical stent is printed using Micro DGP printer and invision tec e-shell 600 clear resin was used. Stainless steel sleeves were placed in the surgical guide then placed in ethanol 99% to remove the excess monomer.
The stent in placed over the mandible and sequential drilling was done until the desired osteotomies width was approached followed by the placement of the implants. Post-operative CBCT was done for the mandible including the implants to assess the accuracy, angulation and position of the placed implants
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Five styrofoam mandibles
Key inclusion criteria (1 listed)
- Five styrofoam mandibles
Key exclusion criteria (1 listed)
- no fractures or pathology
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 |
|---|---|---|
| CBCT ScanningThe Styrofoam mandibles were scanned using CBCT, which was performed for each mandible pre-operatively, the raw DICOM data set obtained from the CBCT scanning were imported to a special third-party software* for secondary reconstruction. | Diagnostic test | – |
Primary outcome
Mesiodistal (MD) Angle
Time frame: 1 year
measures in the software in degrees
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 30 May 2025.
- Individual participant dataSharing planned: Yes
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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?
An observational study of Edentulous Alveolar Ridge and Edentulous Alveolar Ridge In Mandible, run by Eslam Nashaat Saied Ahmed Mohamed 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 30 May 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?
Mesiodistal (MD) Angle (time frame: 1 year). 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 30 May 2025.