- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Mohammed A. Elsawy, PhD
- Telefonnummer: 00201061314522
- E-Mail: mohamed.elsawy@dent.menofia.edu.eg
Studienorte
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Shibin Alkom
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Shibīn al Kawm, Shibin Alkom, Ägypten, 2266166
- Rekrutierung
- Mohammed Elsawy
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Kontakt:
- Mohammed Algharissi, PhD
- E-Mail: mohamed.elsawy@dent.menofia.edu.eg
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
Akzeptiert gesunde Freiwillige
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Diagnose
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: 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).
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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.
Andere Namen:
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.
Andere Namen:
|
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Experimental: 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.
Andere Namen:
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.
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Trueness of Complete-Arch Implant Position Recording
Zeitfenster: Immediately after completion of each digital impression (during the 1 day study visit).
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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.
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Immediately after completion of each digital impression (during the 1 day study visit).
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Angular Deviation of Complete-Arch Implant Position Recording
Zeitfenster: 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.
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Immediately after completion of each digital impression (during the 1 day study visit).
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Effective Chairside Scanning Time
Zeitfenster: Immediately after completion of each digital impression (during the 1 day study visit).
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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.
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Immediately after completion of each digital impression (during the 1 day study visit).
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Mohammed Elsawy, PhD, Menoufia University
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- ADMNF0426
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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