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

NCT07723404 | Recruiting

• 1 other identifier: ADMNF0426
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Edentulism; Edentulism Complete

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Immediately after completion of each digital impression (during the 1 day study visit).

Secondary Outcomes (1)

• Effective Chairside Scanning Time

  Immediately after completion of each digital impression (during the 1 day study visit).

Study Arms (2)

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).

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).

Device: Non-Calibrated Splinting Scan Body System (IoConnect); Device: Mobile Phone-Based Photogrammetry System (T-Marker)

Interventions

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.

Also known as: T-Marker; TruAbutment T-Marker; iPhone 15 Pro Max

Experimental: IoConnect → T-Marker; Experimental: T-Marker → IoConnect

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.

Also known as: IoConnect Flags; True Abutment; Medit i700

Experimental: IoConnect → T-Marker; Experimental: T-Marker → IoConnect

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Menoufia University: lead

Study Sites (1)

Mohammed Elsawy

Shibīn al Kawm, Shibin Alkom, 2266166, Egypt

RECRUITING

Study Officials

• Mohammed Elsawy, PhD

  Menoufia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohammed A. Elsawy, PhD

CONTACT

00201061314522; mohamed.elsawy@dent.menofia.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Prosthodontics

Model Details: 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.

Study Record Dates

• First Submitted: July 18, 2026
• First Posted: July 23, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: July 23, 2026

Record last verified: 2026-07

Locations

EG (1)