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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-60
SponsorMansoura University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Temporomandibular joint disorders or parafunctional habits.

Heavy smokers.

Uncontrolled systemic diseases.

History of chemotherapy or radiotherapy to the head and neck region.

Trial design

Design model

Crossover

Treatments tested in this trial

  • Conventional Splinted Open-Tray Implant Impression

    Other intervention

    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

    Other intervention

    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.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Conventional Splinted Open-Tray ImpressionActive comparator 1 intervention
Group B: Intraoral Digital Scanning with Calibrated FrameworkExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Implant Position Transfer Accuracy (Linear deviations)

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)

Time frame
Immediately after impression procedures following implant placement (same study visit).

Secondary outcomes

1

Implant Position Transfer Accuracy (Angular deviations)

Accuracy of implant position transfer will be assessed 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

Time frame
Immediately after impression procedures following implant placement (same study visit).

Other outcomes

Sponsors and contacts

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