Completely EdentulousNCT06870929
Accuracy of Full Arch Intraoral Scanning
A study testing The Photogrammetry-assisted intraoral scanning, The modified approach of splinting-assisted intraoral scanning and Simple splinting-assisted intraoral scanning in people with Completely Edentulous, run by Ain Shams University at 1 site in Egypt.
Trial summary
Although an intraoral scanner IOS can offer the clinician a completely digital workflow, achieving trustworthy digital scans in edentulous jaws is challenging because of the lack of fixed anatomical landmarks. Read more about this study
- Who is it for?
- Ages 45 to 60 years
- Conditions the study is for
- Completely Edentulous
- What is being tested?
- The Photogrammetry-assisted intraoral scanning, The modified approach of splinting-assisted intraoral scanning and Simple splinting-assisted intraoral scanning
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Mar 2025to 3 Dec 2025
- Phase
- Interventional
- 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 45 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients having a completely edentulous lower arch that could be restored by fixed screw-retained implant prosthesis.
- Patients having a substantial bone height and width at prospective implant sites to install four standard-size implants following the all-on-4 protocol.
- Patients having Sufficient crown height space.
Who cannot join
- Patients with bad oral hygiene.
- Patients with limited mouth opening.
- Vulnerable groups.
- Uncooperative patients.
- Patients receiving or undergoing radiotherapy or chemotherapy. Patients with systemic diseases affecting bone metabolism. Smokers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Different Intraoral Scanning Approaches on the Passive Fit of Mandibular All-on-Four Screw-Retained Frameworks
Although an intraoral scanner IOS can offer the clinician a completely digital workflow, achieving trustworthy digital scans in edentulous jaws is challenging because of the lack of fixed anatomical landmarks. From this perspective, several methods have been proposed to improve the accuracy of digital scanning, however, related results remain inconclusive, and previously proposed devices have had limitations, such as bulkiness, excessive manufacturing requirements, and poor commercial applicability.
Thus, this study aims to clinically compare the effect of conventional versus photogrammetry intraoral scanning methods on the passive fit of mandibular all-on four screw-retained frameworks.
Read the detailed description
The current study will be designed to be a crossover, double-blinded randomized clinical trial. Eighteen edentulous patients will be selected to share in the study to be rehabilitated by screw-retained prostheses following the all-on-4 protocol. After guided implant surgery, patients will be immediately restored by screw-retained acrylic provisionals following the traditional denture conversion technique. The definitive prosthesis will be fabricated after osseointegration starting with the intraoral scanning procedure; each patient will be subjected to three different scanning methods that can enhance the existing IOS workflow; for group I, the Medit i600 will be used to obtain direct intraoral scans while the scan bodies are combined with extra photogrammetry system scanning assistance, for group II, Medit i600 direct intraoral scans will be obtained while applying basic simple splinting along with incorporating a unique tip in the scanning protocol and scanner software, for group III, Medit i600 direct intraoral classical scans will be obtained while applying only a basic simple splinting. The STL file obtained from the different scans will be sent directly to the dental laboratory and three CAD/Milled frameworks will be realized based on the acquired scans. The jigs' passivity will be tested in the patient's mouth by the single screw test followed by the screw resistance test and the screw resistance test parameter will be calculated. The results will be collected for statistical analysis.
- Conditions
- Completely Edentulous
- Being tested
- The Photogrammetry-assisted intraoral scanning, The modified approach of splinting-assisted intraoral scanning, Simple splinting-assisted intraoral scanning
- Keywords
- intraoral scanner, photogrammetry, full arch implant restorations, passive fit, one-screw test, screw resistance test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Photogrammetry-assisted intraoral scanningDevice
The Photogrammetry-assisted intraoral scanning; will be executed using the MUA-compatible ioConnect ® photogrammetry system components exactly in the same sequence as recommended by the manufacturer
The modified approach of splinting-assisted intraoral scanningDevice
The scan bodies will be mounted over the MUA and loosely connected with a power chain before the Medit scanner single-shot scanning procedure. Using the additional scan option in the Medit scanner software, another single-shot scan will be obtained and superimposed to the first scan yielding a color map that reflects the accuracy of the obtained scan and directs a highly precise final scan.
Simple splinting-assisted intraoral scanningDevice
The Medit i600 direct intraoral classical scans will be obtained while applying only a basic simple splinting
| Study group | Role | What they receive |
|---|---|---|
| Simple splinting-assisted intraoral scanning | Active comparator | The Medit i600 direct intraoral classical scans will be obtained while applying only a basic simple splinting Receives: Device: The Photogrammetry-assisted intraoral scanning; Device: The modified approach of splinting-assisted intraoral scanning |
| modified splinting-assisted intraoral scanning technique | Experimental | The Medit i600 direct intraoral scans will be obtained while applying basic simple splinting along with incorporating a unique tip in the scanning protocol and scanner software Receives: Device: Simple splinting-assisted intraoral scanning |
| Photogrammetry-assisted intraoral scanning | Experimental | The Medit i600 will be used to obtain direct intraoral scans while the scan bodies are combined with extra photogrammetry system scanning assistance. Receives: Device: Simple splinting-assisted intraoral scanning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical assessment of passive fit following the latest update of the one screw test
Three CAD/Milled frameworks for each subject will be realized based on the acquired scans. The passive fit of each framework will be assessed intraorally following the Sheffield test: The test Part I involves checking the fit of the framework using finger pressure then tightening one of the most distal abutment screws. when an accurate horizontal and perpendicular fit viewed under magnification (will be categorized as 3 or excellent). If a slight "shadow" or suspicion of a vertical discrepancy, exists between the framework and abutment, a satisfactory passive fit will be confirmed by part 2 of test; If a suspected fit discrepancy can be closed using a 13mm wide modelling wax strip, representing 20 KN/m2 pressure load without distorting, then the fit is deemed to be clinically acceptable (categorized as 2 or good). If the wax does distort or is unable to close the discrepancy, will be (categorized as 1 or poor). this categorization arbitrarily defined by authors.
Measured: six months
Secondary outcomes (1)
objective assessment of clinical passive fit using the screw resistance test parameter
The screw resistance test will be used to objectively evaluate and compare the passive fit of the three frameworks for each subject by calculating the SR parameter as the difference of the rotation angles of each screw in the passive and the non-passive situations by the formula: SR = SR passive - SR non-passive.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start3 Mar 2025
- Primary completion3 Sep 2025 (estimated)
- Study completion3 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Completely EdentulousStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Ibrahim Soliman, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06870929
- Sponsor's protocol ID
- FDASU-RecIR022544
- Status last verified
- Mar 2025
- First submitted
- 3 Mar 2025
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: still study not completed
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Intraoral Scanning Approaches on the Passive Fit of Mandibular All-on-Four Screw-Retained Frameworks
- ClinicalTrials.gov ID
- NCT06870929
- Acronym / sponsor ID
- FDASU-RecIR022544
- Conditions
- Completely Edentulous
- Keywords
- intraoral scanner, photogrammetry, full arch implant restorations, passive fit, one-screw test, screw resistance test
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 3 Mar 2025 (actual)
- Primary completion
- 3 Sep 2025 (estimated)
- Study completion
- 3 Dec 2025 (estimated)
- First posted
- 11 Mar 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.
Although an intraoral scanner IOS can offer the clinician a completely digital workflow, achieving trustworthy digital scans in edentulous jaws is challenging because of the lack of fixed anatomical landmarks. From this perspective, several methods have been proposed to improve the accuracy of digital scanning, however, related results remain inconclusive, and previously proposed devices have had limitations, such as bulkiness, excessive manufacturing requirements, and poor commercial applicability.
Thus, this study aims to clinically compare the effect of conventional versus photogrammetry intraoral scanning methods on the passive fit of mandibular all-on four screw-retained frameworks.
Detailed description
The current study will be designed to be a crossover, double-blinded randomized clinical trial. Eighteen edentulous patients will be selected to share in the study to be rehabilitated by screw-retained prostheses following the all-on-4 protocol. After guided implant surgery, patients will be immediately restored by screw-retained acrylic provisionals following the traditional denture conversion technique. The definitive prosthesis will be fabricated after osseointegration starting with the intraoral scanning procedure; each patient will be subjected to three different scanning methods that can enhance the existing IOS workflow; for group I, the Medit i600 will be used to obtain direct intraoral scans while the scan bodies are combined with extra photogrammetry system scanning assistance, for group II, Medit i600 direct intraoral scans will be obtained while applying basic simple splinting along with incorporating a unique tip in the scanning protocol and scanner software, for group III, Medit i600 direct intraoral classical scans will be obtained while applying only a basic simple splinting. The STL file obtained from the different scans will be sent directly to the dental laboratory and three CAD/Milled frameworks will be realized based on the acquired scans. The jigs' passivity will be tested in the patient's mouth by the single screw test followed by the screw resistance test and the screw resistance test parameter will be calculated. The results will be collected for statistical analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Simple splinting-assisted intraoral scanning | Active comparator | Device: The Photogrammetry-assisted intraoral scanning, Device: The modified approach of splinting-assisted intraoral scanningThe Medit i600 direct intraoral classical scans will be obtained while applying only a basic simple splinting |
| modified splinting-assisted intraoral scanning technique | Experimental | Device: Simple splinting-assisted intraoral scanningThe Medit i600 direct intraoral scans will be obtained while applying basic simple splinting along with incorporating a unique tip in the scanning protocol and scanner software |
| Photogrammetry-assisted intraoral scanning | Experimental | Device: Simple splinting-assisted intraoral scanningThe Medit i600 will be used to obtain direct intraoral scans while the scan bodies are combined with extra photogrammetry system scanning assistance. |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients having a completely edentulous lower arch that could be restored by fixed screw-retained implant prosthesis.
- Patients having a substantial bone height and width at prospective implant sites to install four standard-size implants following the all-on-4 protocol.
- Patients having Sufficient crown height space.
Key exclusion criteria (5 listed)
- Patients with bad oral hygiene.
- Patients with limited mouth opening.
- Vulnerable groups.
- Uncooperative patients.
- Patients receiving or undergoing radiotherapy or chemotherapy. Patients with systemic diseases affecting bone metabolism. Smokers.
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 |
|---|---|---|
| The Photogrammetry-assisted intraoral scanningThe Photogrammetry-assisted intraoral scanning; will be executed using the MUA-compatible ioConnect ® photogrammetry system components exactly in the same sequence as recommended by the manufacturer | Device | Simple splinting-assisted intraoral scanning |
| The modified approach of splinting-assisted intraoral scanningThe scan bodies will be mounted over the MUA and loosely connected with a power chain before the Medit scanner single-shot scanning procedure. Using the additional scan option in the Medit scanner software, another single-shot scan will be obtained and superimposed to the first scan yielding a color map that reflects the accuracy of the obtained scan and directs a highly precise final scan. | Device | Simple splinting-assisted intraoral scanning |
| Simple splinting-assisted intraoral scanningThe Medit i600 direct intraoral classical scans will be obtained while applying only a basic simple splinting | Device | Photogrammetry-assisted intraoral scanning, modified splinting-assisted intraoral scanning technique |
Primary outcome
Clinical assessment of passive fit following the latest update of the one screw test
Time frame: six months
Three CAD/Milled frameworks for each subject will be realized based on the acquired scans. The passive fit of each framework will be assessed intraorally following the Sheffield test: The test Part I involves checking the fit of the framework using finger pressure then tightening one of the most distal abutment screws. when an accurate horizontal and perpendicular fit viewed under magnification (will be categorized as 3 or excellent). If a slight "shadow" or suspicion of a vertical discrepancy, exists between the framework and abutment, a satisfactory passive fit will be confirmed by part 2 of test; If a suspected fit discrepancy can be closed using a 13mm wide modelling wax strip, representing 20 KN/m2 pressure load without distorting, then the fit is deemed to be clinically acceptable (categorized as 2 or good). If the wax does distort or is unable to close the discrepancy, will be (categorized as 1 or poor). this categorization arbitrarily defined by authors.
1 secondary outcome
objective assessment of clinical passive fit using the screw resistance test parameter
Time frame: six months
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 13 Mar 2025.
- Individual participant dataSharing planned: Undecided. still study not completed
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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 The Photogrammetry-assisted intraoral scanning, The modified approach of splinting-assisted intraoral scanning and Simple splinting-assisted intraoral scanning in people with Completely Edentulous, run by Ain Shams 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 3 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 13 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?
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?
Clinical assessment of passive fit following the latest update of the one screw test (time frame: six months). 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 13 Mar 2025.