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

NCT07858682 — Not applicable, Recruiting, 20 participants, Mansoura University

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Accuracy of the Calibrated Framework for Intraoral Full-Arch Scanning Compared With Conventional Splinted Open-Tray Impression in Edentulous Patients: A Crossover Clinical Trial

RegistryNCT07858682
StatusRecruiting
PhaseNot applicable
Study typeInterventional; non randomized, crossover, masking: single, diagnostic
Enrollment20 (Estimated)
SponsorMansoura University (Other)
ConditionsEdentulism, Dental Implants
InterventionsConventional Splinted Open-Tray Implant Impression, Intraoral Digital Scanning Using a Calibrated Framework (Other)
Datesstart 2026-01-01, primary completion 2027-02-01 (estimated), completion 2027-04-01 (estimated), first posted 2026-10-05, last updated 2026-10-05
Locations1 site in Egypt

Related Papers Related Patents Related Grants Related Experts
All trials for Edentulism All trials for Dental Implants All trials of Conventional Splinted Open-Tray Implant Impression All trials of Intraoral Digital Scanning Using a Calibrated Framework

-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.

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+Detailed description

The passive fit of full-arch implant-supported prostheses is a critical factor influencing the long-term success of implant rehabilitation. Because dental implants lack a periodontal ligament, inaccuracies in transferring implant positions may result in framework misfit, leading to biological and mechanical complications such as screw loosening, component fracture, or implant failure. Conventional splinted open-tray impressions are considered the reference standard for full-arch implant impressions; however, they are technique-sensitive, time-consuming, and susceptible to material distortion and operator-related errors.

Advances in digital dentistry have enabled the use of intraoral scanners for implant impressions. Nevertheless, complete-arch digital scanning remains challenging because cumulative stitching errors may reduce scanning accuracy. The use of a calibrated framework has recently been proposed to improve the accuracy of complete-arch intraoral scanning by providing stable geometric reference points during image acquisition. Although promising, clinical evidence comparing this technique with the conventional splinted open-tray impression technique remains limited.

The purpose of this crossover clinical trial is to compare the accuracy of conventional splinted open-tray impressions and intraoral digital scanning using a calibrated framework in completely edentulous patients receiving full-arch implant rehabilitation.

Twenty healthy completely edentulous patients will be recruited. Following implant placement, each participant will undergo both impression techniques. The conventional workflow will consist of a verified splinted open-tray implant impression, while the digital workflow will involve intraoral scanning using a calibrated stock framework attached to implant scan bodies. STL datasets obtained from both techniques will be analyzed using Geomagic Control X software. The digital models will be superimposed to assess linear deviations along the x-, y-, and z-axes, angular deviations, and global three-dimensional deviations. The results will be statistically analyzed to determine whether the calibrated framework-assisted digital workflow provides transfer accuracy comparable to or greater than the conventional impression technique.

+Arms and interventions

ArmTypeInterventionsDescription
Conventional Splinted Open-Tray ImpressionActive comparatorOther: Conventional Splinted Open-Tray Implant ImpressionParticipants will undergo a conventional verified splinted open-tray implant impression following implant placement. Impression copings will be splinted using dental floss and autopolymerizing resin, and a polyvinyl siloxane (PVS) impression will be made. The resulting master cast will be digitized using a laboratory scanner to generate an STL file for accuracy assessment.
Intraoral Digital Scanning with Calibrated FrameworkExperimentalOther: Intraoral Digital Scanning Using a Calibrated FrameworkParticipants will undergo intraoral digital scanning using an intraoral scanner and a calibrated stock framework attached to implant scan bodies after implant placement. The generated STL file will be compared with the conventional impression using Geomagic Control X software to evaluate transfer accuracy.
  • Conventional Splinted Open-Tray Implant Impression (Other), also known as Conventional Implant Impression Open-Tray Impression Splinted Open-Tray Technique: 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), also known as Calibrated Framework Technique Intraoral Digital Impression Full-Arch Intraoral Scanning: 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.

+Outcome measures

Primary outcomes

  • 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)

Secondary outcomes

  • Implant Position Transfer Accuracy (Angular deviations) [Immediately after impression procedures following implant placement (same study visit).]: 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

+Eligibility

Sex: All, ages: 35 Years to 60 Years

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.

+Locations (1)

FacilityCityCountryStatus
Noor Alhuda Rahemm KhalilAl MansurahEgyptRecruiting

+Investigators

  • osama asker, PHD, Study chair, Mansoura University