EdentulismNCT07723404
Comparison of Non-Calibrated Splinting Bodies and T-Marker for Complete-Arch Implant Scanning
A study testing Non-Calibrated Splinting Scan Body System (IoConnect) and Mobile Phone-Based Photogrammetry System (T-Marker) in people with Edentulism and Edentulism Complete, run by Menoufia University at 1 site in Egypt.
Trial summary
This randomized crossover clinical trial aims to compare the accuracy and scanning efficiency of two digital techniques for recording implant positions in completely edentulous patients receiving implant-supported full-arch prostheses. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Edentulism, Edentulism Complete
- What is being tested?
- Non-Calibrated Splinting Scan Body System (IoConnect) and Mobile Phone-Based Photogrammetry System (T-Marker)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2026to 1 Jan 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged 18 years or older.
- Completely edentulous maxilla rehabilitated with four well-integrated implants connected to multiunit abutments.
- Patients presenting with a screw-retained interim implant-supported prosthesis or requiring a definitive implant-supported prosthesis.
- Adequate implant osseointegration with no clinical signs of implant failure.
- Ability to understand the study procedures and provide written informed consent.
Who cannot join
- Fewer than four implants supporting the maxillary prosthesis.
- Implants located outside the maxillary arch.
- Failed implants or implants exhibiting mobility.
- Active peri-implant infection or suppuration.
- Inability to tolerate intraoral scanning or comply with study procedures.
- Refusal or inability 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
Mohammed Elsawy
Shibīn al Kawm, Shibin Alkom, 2266166
Mohammed Algharissi, PhD, mohamed.elsawy@dent.menofia.edu.eg
About this study
Official title: Accuracy of Complete-Arch Implant Scans Obtained Using Non-Calibrated Splinting Bodies and a Mobile Phone-Based Photogrammetry System (T-Marker): A Randomized Crossover Clinical Trial
This randomized crossover clinical trial aims to compare the accuracy and scanning efficiency of two digital techniques for recording implant positions in completely edentulous patients receiving implant-supported full-arch prostheses. Each participant will undergo digital impressions using both a non-calibrated splinting scan body system (IoConnect) with an intraoral scanner and a mobile phone-based photogrammetry system (T-Marker). The order of the two scanning methods will be randomized.
The primary outcome is the accuracy (trueness) of implant position recording, assessed by comparing each digital impression with a verified reference model. Secondary outcomes include the time required to complete each digital impression. The findings of this study may help determine whether these digital workflows provide accurate and efficient alternatives for complete-arch implant impressions, thereby supporting clinical decision-making in implant prosthodontics.
Read the detailed description
Detailed Description
Accurate recording of implant positions is essential for the fabrication of passively fitting implant-supported full-arch prostheses. Although intraoral scanners have demonstrated acceptable accuracy for single implants and short-span restorations, complete-arch implant scanning remains challenging because of the absence of stable anatomical landmarks, long interimplant distances, and cumulative image stitching errors. To overcome these limitations, several digital impression techniques have been developed, including splinted implant scan body systems and photogrammetry-based workflows.
Recently, non-calibrated splinting scan body systems have been introduced to improve the stability of implant scan bodies during intraoral scanning without requiring scanner-specific calibration. In parallel, mobile phone-based photogrammetry systems have emerged as simplified and more accessible alternatives for capturing implant positions. However, clinical evidence directly comparing these technologies is limited.
This prospective randomized crossover clinical trial will compare the accuracy and scanning efficiency of a non-calibrated splinting scan body workflow (IoConnect) with a mobile phone-based photogrammetry system (T-Marker) for complete-arch implant impressions. Twenty-four completely edentulous patients rehabilitated with four implant-supported multiunit abutments will undergo digital impressions using both techniques. The order of the scanning procedures will be randomized using a computer-generated randomization sequence, allowing each participant to serve as their own control.
A verified conventional splinted impression and master cast will be fabricated for each participant and digitized with a high-accuracy laboratory scanner to generate the reference dataset. Digital impressions obtained with both workflows will be compared with the reference model using three-dimensional metrology software. Trueness will be evaluated by measuring linear and angular deviations of implant positions after standardized replacement of the scan bodies with their corresponding CAD library files and construction of an identical virtual implant-supported bar for all datasets.
The primary objective is to compare the trueness of implant position acquisition between the two digital workflows. The secondary objective is to compare the effective chairside scanning time required for implant position acquisition. The results of this study are expected to provide clinical evidence regarding the accuracy and efficiency of these emerging digital workflows and to support evidence-based selection of digital impression techniques for complete-arch implant rehabilitation.
- Conditions
- Edentulism, Edentulism Complete
- Being tested
- Non-Calibrated Splinting Scan Body System (IoConnect), Mobile Phone-Based Photogrammetry System (T-Marker)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Calibrated Splinting Scan Body System (IoConnect)Device
Also called IoConnect Flags; True Abutment; Medit i700
A non-calibrated splinting scan body system used with an intraoral scanner to record complete-arch implant positions. The workflow uses splinted scan bodies that are digitally merged with the soft-tissue scan to generate the definitive implant impression.
Mobile Phone-Based Photogrammetry System (T-Marker)Device
Also called T-Marker; TruAbutment T-Marker; iPhone 15 Pro Max
A smartphone-based photogrammetry system used to capture complete-arch implant positions through optical markers attached to multiunit abutments. The system generates a digital implant position dataset for prosthetic workflow and accuracy assessment.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: IoConnect → T-Marker | Experimental | Participants first undergo complete-arch digital implant impressions using the non-calibrated splinting workflow (IoConnect), followed by the mobile phone-based photogrammetry workflow (T-Marker). Receives: Device: Non-Calibrated Splinting Scan Body System (IoConnect); Device: Mobile Phone-Based Photogrammetry System (T-Marker) |
| Experimental: T-Marker → IoConnect | Experimental | Participants first undergo complete-arch digital implant impressions using the mobile phone-based photogrammetry workflow (T-Marker), followed by the non-calibrated splinting workflow (IoConnect). Receives: Device: Non-Calibrated Splinting Scan Body System (IoConnect); Device: Mobile Phone-Based Photogrammetry System (T-Marker) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trueness of Complete-Arch Implant Position Recording
Trueness will be assessed by comparing each experimental digital implant impression with a verified reference dataset generated from a conventional splinted impression. Three-dimensional analysis will be performed using reverse-engineering software to calculate the linear (µm) and angular (degrees) deviations of implant positions. Lower deviation values indicate greater trueness.
Measured: Immediately after completion of each digital impression (during the 1 day study visit).
Angular Deviation of Complete-Arch Implant Position Recording
Angular trueness will be assessed by comparing each experimental digital implant impression with a verified reference dataset. Three-dimensional analysis will be performed using reverse-engineering software to calculate the angular deviation (degrees) of implant axes. Lower values indicate greater trueness.
Measured: Immediately after completion of each digital impression (during the 1 day study visit).
Secondary outcomes (1)
Effective Chairside Scanning Time
Time required to capture and register implant positions using each digital impression workflow, measured in seconds. Only the implant position acquisition phase will be included; soft-tissue scanning, STL export, and data processing will be excluded.
Measured: Immediately after completion of each digital impression (during the 1 day study visit).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start1 Apr 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EdentulismStudies 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 trial in which each participant undergoes both digital impression workflows: (1) a non-calibrated splinting scan body system (IoConnect) with an intraoral scanner and (2) a mobile phone-based photogrammetry system (T-Marker). The order of the two interventions is determined using a computer-generated randomization sequence. Each participant serves as their own control, reducing inter-individual variability and minimizing potential order effects.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed El-Sawy, Menoufia University
- Investigators
- Mohammed Elsawy, PhD, Principal investigator, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07723404
- Sponsor's protocol ID
- ADMNF-0226
- Status last verified
- Sep 2026
- First submitted
- 18 Jul 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Complete-Arch Implant Scans Obtained Using Non-Calibrated Splinting Bodies and a Mobile Phone-Based Photogrammetry System (T-Marker): A Randomized Crossover Clinical Trial
- ClinicalTrials.gov ID
- NCT07723404
- Acronym / sponsor ID
- ADMNF-0226
- Conditions
- Edentulism, Edentulism Complete
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 23 Jul 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 trial aims to compare the accuracy and scanning efficiency of two digital techniques for recording implant positions in completely edentulous patients receiving implant-supported full-arch prostheses. Each participant will undergo digital impressions using both a non-calibrated splinting scan body system (IoConnect) with an intraoral scanner and a mobile phone-based photogrammetry system (T-Marker). The order of the two scanning methods will be randomized.
The primary outcome is the accuracy (trueness) of implant position recording, assessed by comparing each digital impression with a verified reference model. Secondary outcomes include the time required to complete each digital impression. The findings of this study may help determine whether these digital workflows provide accurate and efficient alternatives for complete-arch implant impressions, thereby supporting clinical decision-making in implant prosthodontics.
Detailed description
Detailed Description
Accurate recording of implant positions is essential for the fabrication of passively fitting implant-supported full-arch prostheses. Although intraoral scanners have demonstrated acceptable accuracy for single implants and short-span restorations, complete-arch implant scanning remains challenging because of the absence of stable anatomical landmarks, long interimplant distances, and cumulative image stitching errors. To overcome these limitations, several digital impression techniques have been developed, including splinted implant scan body systems and photogrammetry-based workflows.
Recently, non-calibrated splinting scan body systems have been introduced to improve the stability of implant scan bodies during intraoral scanning without requiring scanner-specific calibration. In parallel, mobile phone-based photogrammetry systems have emerged as simplified and more accessible alternatives for capturing implant positions. However, clinical evidence directly comparing these technologies is limited.
This prospective randomized crossover clinical trial will compare the accuracy and scanning efficiency of a non-calibrated splinting scan body workflow (IoConnect) with a mobile phone-based photogrammetry system (T-Marker) for complete-arch implant impressions. Twenty-four completely edentulous patients rehabilitated with four implant-supported multiunit abutments will undergo digital impressions using both techniques. The order of the scanning procedures will be randomized using a computer-generated randomization sequence, allowing each participant to serve as their own control.
A verified conventional splinted impression and master cast will be fabricated for each participant and digitized with a high-accuracy laboratory scanner to generate the reference dataset. Digital impressions obtained with both workflows will be compared with the reference model using three-dimensional metrology software. Trueness will be evaluated by measuring linear and angular deviations of implant positions after standardized replacement of the scan bodies with their corresponding CAD library files and construction of an identical virtual implant-supported bar for all datasets.
The primary objective is to compare the trueness of implant position acquisition between the two digital workflows. The secondary objective is to compare the effective chairside scanning time required for implant position acquisition. The results of this study are expected to provide clinical evidence regarding the accuracy and efficiency of these emerging digital workflows and to support evidence-based selection of digital impression techniques for complete-arch implant rehabilitation.
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 trial in which each participant undergoes both digital impression workflows: (1) a non-calibrated splinting scan body system (IoConnect) with an intraoral scanner and (2) a mobile phone-based photogrammetry system (T-Marker). The order of the two interventions is determined using a computer-generated randomization sequence. Each participant serves as their own control, reducing inter-individual variability and minimizing potential order effects.
| Arm | Type | Receives |
|---|---|---|
| Experimental: IoConnect → T-Marker | Experimental | Device: Non-Calibrated Splinting Scan Body System (IoConnect), Device: Mobile Phone-Based Photogrammetry System (T-Marker)Participants first undergo complete-arch digital implant impressions using the non-calibrated splinting workflow (IoConnect), followed by the mobile phone-based photogrammetry workflow (T-Marker). |
| Experimental: T-Marker → IoConnect | Experimental | Device: Non-Calibrated Splinting Scan Body System (IoConnect), Device: Mobile Phone-Based Photogrammetry System (T-Marker)Participants first undergo complete-arch digital implant impressions using the mobile phone-based photogrammetry workflow (T-Marker), followed by the non-calibrated splinting workflow (IoConnect). |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adults aged 18 years or older.
- Completely edentulous maxilla rehabilitated with four well-integrated implants connected to multiunit abutments.
- Patients presenting with a screw-retained interim implant-supported prosthesis or requiring a definitive implant-supported prosthesis.
- Adequate implant osseointegration with no clinical signs of implant failure.
- Ability to understand the study procedures and provide written informed consent.
Key exclusion criteria (6 listed)
- Fewer than four implants supporting the maxillary prosthesis.
- Implants located outside the maxillary arch.
- Failed implants or implants exhibiting mobility.
- Active peri-implant infection or suppuration.
- Inability to tolerate intraoral scanning or comply with study procedures.
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 |
|---|---|---|
| Non-Calibrated Splinting Scan Body System (IoConnect)Also: IoConnect Flags; True Abutment; Medit i700A non-calibrated splinting scan body system used with an intraoral scanner to record complete-arch implant positions. The workflow uses splinted scan bodies that are digitally merged with the soft-tissue scan to generate the definitive implant impression. | Device | Experimental: IoConnect → T-Marker, Experimental: T-Marker → IoConnect |
| Mobile Phone-Based Photogrammetry System (T-Marker)Also: T-Marker; TruAbutment T-Marker; iPhone 15 Pro MaxA smartphone-based photogrammetry system used to capture complete-arch implant positions through optical markers attached to multiunit abutments. The system generates a digital implant position dataset for prosthetic workflow and accuracy assessment. | Device | Experimental: IoConnect → T-Marker, Experimental: T-Marker → IoConnect |
Primary outcome
Trueness of Complete-Arch Implant Position Recording
Time frame: Immediately after completion of each digital impression (during the 1 day study visit).
Trueness will be assessed by comparing each experimental digital implant impression with a verified reference dataset generated from a conventional splinted impression. Three-dimensional analysis will be performed using reverse-engineering software to calculate the linear (µm) and angular (degrees) deviations of implant positions. Lower deviation values indicate greater trueness.
Angular Deviation of Complete-Arch Implant Position Recording
Time frame: Immediately after completion of each digital impression (during the 1 day study visit).
Angular trueness will be assessed by comparing each experimental digital implant impression with a verified reference dataset. Three-dimensional analysis will be performed using reverse-engineering software to calculate the angular deviation (degrees) of implant axes. Lower values indicate greater trueness.
1 secondary outcome
Effective Chairside Scanning Time
Time frame: Immediately after completion of each digital impression (during the 1 day study visit).
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 9 Sep 2026.
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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.
Mohammed Elsawy, PhD principal investigator
Menoufia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-Calibrated Splinting Scan Body System (IoConnect) and Mobile Phone-Based Photogrammetry System (T-Marker) in people with Edentulism and 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 6 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 9 Sep 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. Elsawy, PhD (00201061314522, mohamed.elsawy@dent.menofia.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trueness of Complete-Arch Implant Position Recording (time frame: Immediately after completion of each digital impression (during the 1 day study visit).). The study lists 2 primary outcomes in all. 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 9 Sep 2026.