- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07723404
Comparison of Non-Calibrated Splinting Bodies and T-Marker for Complete-Arch Implant Scanning
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.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Mohammed A. Elsawy, PhD
- Numéro de téléphone: 00201061314522
- E-mail: mohamed.elsawy@dent.menofia.edu.eg
Lieux d'étude
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Shibin Alkom
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Shibīn al Kawm, Shibin Alkom, Egypte, 2266166
- Recrutement
- Mohammed Elsawy
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Contact:
- Mohammed Algharissi, PhD
- E-mail: mohamed.elsawy@dent.menofia.edu.eg
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Experimental: IoConnect → 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).
|
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.
Autres noms:
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.
Autres noms:
|
|
Expérimental: Experimental: T-Marker → IoConnect
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).
|
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.
Autres noms:
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.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Trueness of Complete-Arch Implant Position Recording
Délai: 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.
|
Immediately after completion of each digital impression (during the 1 day study visit).
|
|
Angular Deviation of Complete-Arch Implant Position Recording
Délai: Immediately after completion of each digital impression (during the 1 day study visit).
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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).
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Effective Chairside Scanning Time
Délai: Immediately after completion of each digital impression (during the 1 day study visit).
|
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.
|
Immediately after completion of each digital impression (during the 1 day study visit).
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Mohammed Elsawy, PhD, Menoufia University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- ADMNF-0226
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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