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RECRUITING Not applicable ClinicalTrials.gov

Comparison of Non-Calibrated Splinting Bodies and T-Marker for Complete-Arch Implant Scanning

Sponsor: Menoufia University • ClinicalTrials.gov ID: NCT07723404

Registry updated: 2026-09-09
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Description

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.

Interventions

  • Non-Calibrated Splinting Scan Body System (IoConnect) (Device)
    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)
    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.

Eligibility criteria

Inclusion Criteria * 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. Exclusion Criteria * 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.

Conditions

Edentulism Edentulism Complete

Locations

  • Mohammed Elsawy — Shibīn al Kawm, Shibin Alkom, Egypt
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record