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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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.

Mohammed A. El-Sawy, PhD contact

00201061314522

Dr_Sawy@windowslive.com

Egypt1 site, 1 recruiting
  • Faculty of Dentistry, Menoufia University

    Shibīn al Kawm, Menoufia, 2266166

    Mohammed A. El-Sawy, PhD, 00201061314522, mohamed.elsawy@dent.menofia.edu.eg

    Recruiting

Other trials in Egypt

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.

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 groups in NCT07862218
Study groupRoleWhat they receive
Scan Pro → IoConnectExperimentalParticipants 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 ProExperimentalParticipants 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.

  1. 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)
  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.

  1. First posted7 Oct 2026
  2. Study start1 Jan 2026
  3. Primary completion1 Jan 2027 (estimated)
  4. Study completion1 Feb 2027 (estimated)

Resources

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)
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

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.

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