Accuracy of the Calibrated Framework for Intra Oral Full Arch Scan (A Cross-over Study)
Accuracy of the Calibrated Framework for Intraoral Full-Arch Scanning Compared With Conventional Splinted Open-Tray Impression in Edentulous Patients: A Crossover Clinical 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.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: noor alhuda raheem, BDS
- Telefonnummer: 01044487126
- E-post: nooralkhalil95@yahoo.com
Studieorter
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Al Mansurah, Egypten, 12345
- Rekrytering
- Noor Alhuda Rahemm Khalil
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Kontakt:
- osama asker, PHD
- Telefonnummer: 01010848407
- E-post: osamaasker@gmail.com
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Diagnostisk
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Aktiv komparator: Conventional Splinted Open-Tray 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. |
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.
Andra namn:
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Experimentell: Intraoral Digital Scanning with 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. |
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.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Implant Position Transfer Accuracy (Linear deviations)
Tidsram: Immediately after impression procedures following implant placement (same study visit).
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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) |
Immediately after impression procedures following implant placement (same study visit).
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Implant Position Transfer Accuracy (Angular deviations)
Tidsram: Immediately after impression procedures following implant placement (same study visit).
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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 |
Immediately after impression procedures following implant placement (same study visit).
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Samarbetspartners och utredare
Sponsor
Utredare
- Studiestol: osama asker, PHD, Mansoura University
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- MS.26.01.135
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
upon request from the corresponding author
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