Ireland
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Recruiting Not applicable

Accuracy of the Calibrated Framework for Intra Oral Full Arch Scan (A Cross-over Study)

NCT07858682 · tracked via the Priya Life Science Egypt tracker
Phase
Not applicable
Started
2026-01-01
Last updated
2026-10-05

Condition(s) studied

EdentulismDental Implants

Investigational drug(s) / intervention(s)

Conventional Splinted Open-Tray Implant ImpressionIntraoral Digital Scanning Using a Calibrated Framework

Conventional Splinted Open-Tray Implant Impression: A conventional verified splinted open-tray implant impression will be performed after implant placement. Multi-unit impression copings will be splinted using dental floss and autopolymerizing resin, followed by a polyvinyl siloxane (PVS) impression. The master cast will be fabricated, verified, and scanned with a laboratory scanner to generate an STL file for accuracy analysis.

Intraoral Digital Scanning Using a Calibrated Framework: An intraoral digital impression will be obtained after implant placement using an intraoral scanner and a calibrated stock framework attached to implant scan bodies. The resulting STL dataset will be compared with the conventional impression using Geomagic Control X software to evaluate linear, angular, and global deviations in implant position transfer accuracy.

Study summary

This crossover clinical trial aims to compare the accuracy of conventional splinted open-tray implant impressions with intraoral digital scanning using a calibrated framework in completely edentulous patients rehabilitated with full-arch implant-supported prostheses. Accurate transfer of implant positions is essential for achieving a passive fit of the prosthetic framework and minimizing biological and mechanical complications.

Twenty healthy completely edentulous patients requiring full-arch implant rehabilitation will be enrolled. Each participant will undergo both conventional and digital impression techniques following implant placement, allowing direct within-subject comparison. The conventional technique consists of a verified splinted open-tray impression, while the digital technique uses an intraoral scanner in combination with a calibrated stock framework.

The accuracy of the two impression techniques will be evaluated by superimposing the resulting STL files using Geomagic Control X software. Linear deviations in the x-, y-, and z-axes, angular deviations, and global deviations will be measured and compared. The findings of this study are expected to provide clinical evidence regarding the accuracy of calibrated framework-assisted intraoral scanning compared with the conventional impression technique for full-arch implant rehabilitation.

Eligibility

Sex
ALL
Min age
35 Years
Max age
60 Years
Healthy volunteers
No
Inclusion Criteria: * Adults aged 18 years or older. * Completely edentulous maxilla and mandible for at least 6 months following the last tooth extraction. * Angle's Class I maxillomandibular relationship with adequate interarch space. * Sufficient residual alveolar bone quantity and quality to receive dental implants. * Good oral hygiene. * Free from uncontrolled systemic diseases or conditions that may interfere with implant osseointegration. * Able and willing to provide written informed consent. Exclusion Criteria: * Temporomandibular joint disorders or parafunctional habits. * Heavy smokers. * Uncontrolled systemic diseases. * History of chemotherapy or radiotherapy to the head and neck region. * Poor neuromuscular coordination. * Localized bone defects that could compromise implant placement.

Primary outcome measure(s)

  • Implant Position Transfer Accuracy (Linear deviations) — Immediately after impression procedures following implant placement (same study visit).
    by superimposing STL files obtained from the conventional splinted open-tray impression and intraoral digital scanning using a calibrated framework with Geomagic Control X software. Linear deviations (x-, y-, and z-axes)

Trial sites (1)

FacilityCityRegionStatus
Noor Alhuda Rahemm Khalil Al Mansurah Egypt Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07858682 on ClinicalTrials.gov ↗ ← All trials in Egypt