Accuracy of the Calibrated Framework for Intraoral Full-Arch Scanning Compared With Conventional Splinted Open-Tray Impression in Edentulous Patients: A Crossover Clinical Trial
| Registry | NCT07858682 |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; non randomized, crossover, masking: single, diagnostic |
| Enrollment | 20 (Estimated) |
| Sponsor | Mansoura University (Other) |
| Conditions | Edentulism, Dental Implants |
| Interventions | Conventional Splinted Open-Tray Implant Impression, Intraoral Digital Scanning Using a Calibrated Framework (Other) |
| Dates | start 2026-01-01, primary completion 2027-02-01 (estimated), completion 2027-04-01 (estimated), first posted 2026-10-05, last updated 2026-10-05 |
| Locations | 1 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
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Conventional Splinted Open-Tray Impression | Active comparator | Other: Conventional Splinted Open-Tray Implant Impression | Participants 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 Framework | Experimental | Other: Intraoral Digital Scanning Using a Calibrated Framework | Participants 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. |
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Noor Alhuda Rahemm Khalil | Al Mansurah | Egypt | Recruiting |