Edentulism CompleteNCT07862218
Accuracy of Complete-Arch Implant Scans Using Non Calibrated Splinting Scanbodies
A study testing Scan Pro and IoConnect in people with Edentulism Complete, run by Menoufia University at 1 site in Egypt.
Trial summary
This randomized crossover clinical study will evaluate and compare the accuracy and chairside time of two non-calibrated splinting systems, IoConnect and Scan Pro, for obtaining complete-arch implant digital scans. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Edentulism Complete
- What is being tested?
- Scan Pro and IoConnect
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2026to 1 Feb 2027
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older.
- Completely edentulous maxilla or mandible.
- Four clinically stable and osseointegrated implants restored with multiunit abutments.
- Patients with a screw-retained interim prosthesis or patients scheduled to receive a definitive complete-arch implant-supported prosthesis.
- Ability to undergo intraoral scanning procedures and provide written informed consent.
Who cannot join
- Fewer or more than four implants in the evaluated arch.
- Failed or clinically unstable implants.
- Active peri-implant infection or suppuration.
- Limited mouth opening that prevents completion of the intraoral scanning procedures.
- Inability or unwillingness to provide written informed consent.
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
Faculty of Dentistry, Menoufia University
Shibīn al Kawm, Menoufia, 2266166
Mohammed A. El-Sawy, PhD, 00201061314522, mohamed.elsawy@dent.menofia.edu.eg
About this study
Official title: Accuracy of Complete-Arch Implant Scans Using Two Non-Calibrated Splinting Systems: A Randomized Crossover Clinical Study of IoConnect and Scan Pro
This randomized crossover clinical study will evaluate and compare the accuracy and chairside time of two non-calibrated splinting systems, IoConnect and Scan Pro, for obtaining complete-arch implant digital scans. The study will include completely edentulous patients with four well-integrated implants connected to multiunit abutments.
Each participant will undergo complete-arch implant scanning using both systems, with the order of the scanning protocols determined by a computer-generated randomization sequence. The digital scans obtained with each system will be compared with a verified conventional implant impression used to establish a reference model.
The primary evaluation will focus on the accuracy of the implant scans by assessing linear and angular discrepancies between each experimental scan and the reference model. Chairside time required for the scanning procedures will also be recorded. The study will determine whether differences exist between the two non-calibrated splinting systems in terms of complete-arch implant scan accuracy.
Read the detailed description
Complete-arch implant scanning can be challenging because errors during image acquisition and stitching may accumulate across the arch. Non-calibrated splinting techniques have been introduced to stabilize implant scan bodies and improve the reliability of complete-arch digital implant impressions without requiring scanner-specific calibration.
This randomized crossover clinical study will evaluate and compare two non-calibrated splinting systems, IoConnect and Scan Pro, for complete-arch implant scanning in completely edentulous patients rehabilitated with implant-supported prostheses.
Eligible participants will have a completely edentulous maxilla or mandible and four well-integrated implants connected to multiunit abutments. Patients with fewer or more than four implants, failed implants, active peri-implant infection or suppuration, or limited mouth opening will be excluded.
A verified conventional splinted implant impression will first be obtained to establish a reference cast. Open-tray impression copings will be splinted intraorally using chemically polymerized acrylic resin, and the definitive impression will be made using polyvinyl siloxane impression material. A verification jig will be fabricated and used to confirm the passive fit of the reference cast. The verified reference cast will subsequently be digitized using a calibrated laboratory scanner to generate the reference digital model.
Each participant will undergo both digital scanning protocols. The order of the two protocols will be randomized using a computer-generated randomization sequence to minimize potential order and operator learning effects.
For the Scan Pro workflow, implant scan bodies will be connected to the multiunit abutments, and adjustable arms will be added to provide optical splinting. The complete-arch implant scan will then be obtained using an intraoral scanner.
For the IoConnect workflow, peri-implant soft-tissue anatomy will first be captured using healing abutments. Following removal of the healing abutments, horizontal IoConnect scan bodies will be attached to the multiunit abutments and a complete-arch implant scan will be obtained using the same intraoral scanner. The soft-tissue scan and optical marker scan will subsequently be merged using the dedicated software to generate the final digital implant impression.
To standardize the datasets and minimize the influence of differences in scan-body geometry and digital mesh reconstruction, the scan bodies captured during scanning will be replaced with the corresponding manufacturer-provided CAD library files. An identical implant-supported bar framework will then be virtually designed for each dataset. The resulting STL files will be analyzed using three-dimensional reverse-engineering software.
Accuracy will be assessed by comparing the experimental datasets with the reference digital model. Linear discrepancy will be determined as the three-dimensional Euclidean distance between corresponding implant measurement points, while angular discrepancy will be determined as the angle between corresponding implant longitudinal axes. Measurements will be obtained for all four implants in each dataset, and mean linear and angular discrepancies will be calculated.
Chairside time associated with the digital scanning procedures will also be evaluated. Statistical analysis will include assessment of data normality and comparison of the paired linear and angular deviations between the two scanning protocols using a paired t-test, with statistical significance set at α = .05.
- Conditions
- Edentulism Complete
- Being tested
- Scan Pro, IoConnect
- Keywords
- Complete-arch implant scanning, Intraoral scanning, Digital implant impressions, Implant scan accuracy, Noncalibrated splinting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scan ProDevice
Complete-arch implant scanning using the Scan Pro noncalibrated splinting system and an intraoral scanner. The scan bodies are connected using adjustable arms to provide optical splinting, and the resulting digital impression is exported as an STL file for accuracy assessment.
IoConnectDevice
Complete-arch implant scanning using the IoConnect noncalibrated splinting system and an intraoral scanner. The workflow includes acquisition of peri-implant soft-tissue anatomy followed by acquisition of the horizontal optical markers. The datasets are merged using the dedicated software to generate the final digital implant impression.
| Study group | Role | What they receive |
|---|---|---|
| Scan Pro → IoConnect | Experimental | Participants randomized to this sequence will undergo complete-arch implant scanning using the Scan Pro noncalibrated splinting system first, followed by complete-arch implant scanning using the IoConnect noncalibrated splinting system. Each participant will undergo both scanning protocols, with the order determined by computer-generated randomization. Receives: Device: Scan Pro; Device: IoConnect |
| IoConnect → Scan Pro | Experimental | Participants randomized to this sequence will undergo complete-arch implant scanning using the IoConnect noncalibrated splinting system first, followed by complete-arch implant scanning using the Scan Pro noncalibrated splinting system. Each participant will undergo both scanning protocols, with the order determined by computer-generated randomization. Receives: Device: Scan Pro; Device: IoConnect |
What is being measured
The primary outcome is the main question the study is designed to answer.
Linear trueness of complete-arch implant scans
Linear trueness will be assessed as the three-dimensional Euclidean deviation between corresponding implant positions in the reference digital dataset and each experimental scan dataset. For each participant, the mean linear deviation across the four implants will be calculated for each scanning protocol. Lower deviation values indicate greater trueness.
Measured: Immediately after completion of each scanning protocol
Secondary outcomes (1)
Angular trueness of complete-arch implant scans
Angular trueness will be assessed as the angular deviation between the corresponding longitudinal axes of the implants in the reference digital dataset and each experimental scan dataset. For each participant, the mean angular deviation across the four implants will be calculated for each scanning protocol. Lower angular deviation values indicate greater trueness.
Measured: Immediately after completion of each scanning protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start1 Jan 2026
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulism CompleteStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a randomized, two-period crossover clinical study. Each participant will undergo both complete-arch implant scanning protocols (Scan Pro and IoConnect), with the order of the two protocols determined by computer-generated randomization. Each participant will therefore serve as their own control. Linear and angular scan trueness and chairside scanning time will be compared between the two protocols.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Collaborators
- Mansoura University
- Responsible party
- Principal investigator, Mohammed El-Sawy, Menoufia University
- Investigators
- Mohammed El-Sawy, PhD, Principal investigator, Menoufia, Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07862218
- Sponsor's protocol ID
- ADMNF110926
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Up on request for reasonable reason
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Complete-Arch Implant Scans Using Two Non-Calibrated Splinting Systems: A Randomized Crossover Clinical Study of IoConnect and Scan Pro
- ClinicalTrials.gov ID
- NCT07862218
- Acronym / sponsor ID
- ADMNF110926
- Conditions
- Edentulism Complete
- Keywords
- Complete-arch implant scanning, Intraoral scanning, Digital implant impressions, Implant scan accuracy, Noncalibrated splinting
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Collaborators
- Mansoura University
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 7 Oct 2026 (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.
This randomized crossover clinical study will evaluate and compare the accuracy and chairside time of two non-calibrated splinting systems, IoConnect and Scan Pro, for obtaining complete-arch implant digital scans. The study will include completely edentulous patients with four well-integrated implants connected to multiunit abutments.
Each participant will undergo complete-arch implant scanning using both systems, with the order of the scanning protocols determined by a computer-generated randomization sequence. The digital scans obtained with each system will be compared with a verified conventional implant impression used to establish a reference model.
The primary evaluation will focus on the accuracy of the implant scans by assessing linear and angular discrepancies between each experimental scan and the reference model. Chairside time required for the scanning procedures will also be recorded. The study will determine whether differences exist between the two non-calibrated splinting systems in terms of complete-arch implant scan accuracy.
Detailed description
Complete-arch implant scanning can be challenging because errors during image acquisition and stitching may accumulate across the arch. Non-calibrated splinting techniques have been introduced to stabilize implant scan bodies and improve the reliability of complete-arch digital implant impressions without requiring scanner-specific calibration.
This randomized crossover clinical study will evaluate and compare two non-calibrated splinting systems, IoConnect and Scan Pro, for complete-arch implant scanning in completely edentulous patients rehabilitated with implant-supported prostheses.
Eligible participants will have a completely edentulous maxilla or mandible and four well-integrated implants connected to multiunit abutments. Patients with fewer or more than four implants, failed implants, active peri-implant infection or suppuration, or limited mouth opening will be excluded.
A verified conventional splinted implant impression will first be obtained to establish a reference cast. Open-tray impression copings will be splinted intraorally using chemically polymerized acrylic resin, and the definitive impression will be made using polyvinyl siloxane impression material. A verification jig will be fabricated and used to confirm the passive fit of the reference cast. The verified reference cast will subsequently be digitized using a calibrated laboratory scanner to generate the reference digital model.
Each participant will undergo both digital scanning protocols. The order of the two protocols will be randomized using a computer-generated randomization sequence to minimize potential order and operator learning effects.
For the Scan Pro workflow, implant scan bodies will be connected to the multiunit abutments, and adjustable arms will be added to provide optical splinting. The complete-arch implant scan will then be obtained using an intraoral scanner.
For the IoConnect workflow, peri-implant soft-tissue anatomy will first be captured using healing abutments. Following removal of the healing abutments, horizontal IoConnect scan bodies will be attached to the multiunit abutments and a complete-arch implant scan will be obtained using the same intraoral scanner. The soft-tissue scan and optical marker scan will subsequently be merged using the dedicated software to generate the final digital implant impression.
To standardize the datasets and minimize the influence of differences in scan-body geometry and digital mesh reconstruction, the scan bodies captured during scanning will be replaced with the corresponding manufacturer-provided CAD library files. An identical implant-supported bar framework will then be virtually designed for each dataset. The resulting STL files will be analyzed using three-dimensional reverse-engineering software.
Accuracy will be assessed by comparing the experimental datasets with the reference digital model. Linear discrepancy will be determined as the three-dimensional Euclidean distance between corresponding implant measurement points, while angular discrepancy will be determined as the angle between corresponding implant longitudinal axes. Measurements will be obtained for all four implants in each dataset, and mean linear and angular discrepancies will be calculated.
Chairside time associated with the digital scanning procedures will also be evaluated. Statistical analysis will include assessment of data normality and comparison of the paired linear and angular deviations between the two scanning protocols using a paired t-test, with statistical significance set at α = .05.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a randomized, two-period crossover clinical study. Each participant will undergo both complete-arch implant scanning protocols (Scan Pro and IoConnect), with the order of the two protocols determined by computer-generated randomization. Each participant will therefore serve as their own control. Linear and angular scan trueness and chairside scanning time will be compared between the two protocols.
| Arm | Type | Receives |
|---|---|---|
| Scan Pro → IoConnect | Experimental | Device: Scan Pro, Device: IoConnectParticipants randomized to this sequence will undergo complete-arch implant scanning using the Scan Pro noncalibrated splinting system first, followed by complete-arch implant scanning using the IoConnect noncalibrated splinting system. Each participant will undergo both scanning protocols, with the order determined by computer-generated randomization. |
| IoConnect → Scan Pro | Experimental | Device: Scan Pro, Device: IoConnectParticipants randomized to this sequence will undergo complete-arch implant scanning using the IoConnect noncalibrated splinting system first, followed by complete-arch implant scanning using the Scan Pro noncalibrated splinting system. Each participant will undergo both scanning protocols, with the order determined by computer-generated randomization. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18 years or older.
- Completely edentulous maxilla or mandible.
- Four clinically stable and osseointegrated implants restored with multiunit abutments.
- Patients with a screw-retained interim prosthesis or patients scheduled to receive a definitive complete-arch implant-supported prosthesis.
- Ability to undergo intraoral scanning procedures and provide written informed consent.
Key exclusion criteria (5 listed)
- Fewer or more than four implants in the evaluated arch.
- Failed or clinically unstable implants.
- Active peri-implant infection or suppuration.
- Limited mouth opening that prevents completion of the intraoral scanning procedures.
- Inability or unwillingness to provide written informed consent.
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 |
|---|---|---|
| Scan ProComplete-arch implant scanning using the Scan Pro noncalibrated splinting system and an intraoral scanner. The scan bodies are connected using adjustable arms to provide optical splinting, and the resulting digital impression is exported as an STL file for accuracy assessment. | Device | IoConnect → Scan Pro, Scan Pro → IoConnect |
| IoConnectComplete-arch implant scanning using the IoConnect noncalibrated splinting system and an intraoral scanner. The workflow includes acquisition of peri-implant soft-tissue anatomy followed by acquisition of the horizontal optical markers. The datasets are merged using the dedicated software to generate the final digital implant impression. | Device | IoConnect → Scan Pro, Scan Pro → IoConnect |
Primary outcome
Linear trueness of complete-arch implant scans
Time frame: Immediately after completion of each scanning protocol
Linear trueness will be assessed as the three-dimensional Euclidean deviation between corresponding implant positions in the reference digital dataset and each experimental scan dataset. For each participant, the mean linear deviation across the four implants will be calculated for each scanning protocol. Lower deviation values indicate greater trueness.
1 secondary outcome
Angular trueness of complete-arch implant scans
Time frame: Immediately after completion of each scanning protocol
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 Oct 2026.
- Individual participant dataSharing planned: No. Up on request for reasonable reason
Related trials for Edentulism Complete
Not yet recruitingObservational study
Russian Version of OHIP-EDENT-19 for Adults With Complete Tooth Loss
Edentulism
Active, not recruiting
Titanium Versus Nano-Carbon CAD/CAM Frameworks for All-on-4 Implant Supported Hybrid Prosthesis.
Complete Edentulism
Not yet recruiting
Comparison of Open-Mouth and Closed-Mouth Impression Techniques for Complete Dentures
Edentulism
Recruiting
Nutritional Intervention for Older Adults With Complete Dentures
Edentulism Complete, Denture, Complete
Recruiting
Microbial Adhesion and Peri-Implant Tissue Health in All-on-Four Hybrid Prostheses Supported by Zantex or Zirconia Frameworks
Complete Edentulism
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 El-Sawy, PhD principal investigator
Menoufia, Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scan Pro and IoConnect in people with Edentulism Complete, 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 5 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: looking for participants now, as of the sponsor's last update on 13 Oct 2026. 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 (00201061314522, Dr_Sawy@windowslive.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Linear trueness of complete-arch implant scans (time frame: Immediately after completion of each scanning protocol). 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 Oct 2026.