Comparison of Non-Calibrated Splinting Bodies and T-Marker for Complete-Arch Implant Scanning
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-60
SponsorMenoufia University
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Crossover
Treatments tested in this trial
Non-Calibrated Splinting Scan Body System (IoConnect)
DeviceA 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)
DeviceA 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Experimental: IoConnect → T-MarkerExperimental treatment 2 interventions
Group B: Experimental: T-Marker → IoConnectExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Immediately after completion of each digital impression (during the 1 day study visit).2
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.
Time frame
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.
Time frame
Immediately after completion of each digital impression (during the 1 day study visit).Sponsors and contacts
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Source ClinicalTrials.gov