Comparative Analysis About the Dimensional Accuracy of Diagnostic Trial Restoration Transferring Performed With Four Different Methods for Trial Restoration Matrix Fabrication: an in Vivo Study
Sponsor study identifier
observational
20
1 country
1
Study Start
January 8, 2023
Actual (reported)Primary Completion
June 22, 2023
Actual (reported)Study Completion
November 3, 2023
Actual (reported)This observational analytical in vivo study aimed to assess the dimensional accuracy of diagnostic trial restorations fabricated through four different techniques: condensation silicone matrix without external shell, addition polyvinylsiloxane (PVS)-silicone matrix with an external resin-based shell, transparent addition PVS-silicone matrix with an external vacuum shell, and a CAD/CAM combination matrix. Methods: Patients (n=20) in need of anterior upper teeth aesthetic rehabilitation were recruited. Clinical and radiographic examinations, intraoral scanning, and dental CAD software were used to design a virtual diagnostic waxing. A 3D printed waxed cast was obtained, and four different matrices were fabricated. Trial restorations were performed using calibrated materials, and intraoral scans were taken for each restoration. Linear and volumetric discrepancies were evaluated using reverse engineering alignment software
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 3, 2023
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 8, 2023
Actual (reported)June 22, 2023
Actual (reported)November 3, 2023
Actual (reported)March 21, 2025
Actual (reported)April 4, 2025
Actual (reported)Volumetric discrepancy
. Each trial restoration IOS (addition, condensation, clear, combined) was imported and aligned to the control reference STL cast of the waxed printed cast using the "best fit" algorithm of a non-dental reverse engineering software (Cx Geomagic Control X). Volumetric discrepancies, limited to the diagnostic waxing area, were measured using the RMS value.
From enrollment the patient underwent the different procedures within a month. The four procedures were delivered to the patient the same day, one after the other, in an order determined by the randomization
base and catalyst paste, 85 Shore A (Zetalabor, Zhermack) were mixed and applied over the waxing printed cast ensuring an overall even distribution of the material buccally and incisally over the cast guaranteeing a minimal thickness of 8-10mm. The setting time advised by the fabricant was respected. After, the condensation silicone matrix was measured, marked and trimmed, using a dental model trimmer (Dual wheel dental model trimmer, Dentaurum Inc.) to obtain a 6 mm thickness of the matrix. Finally, a vacuum shell was fabricated over the final volume of the condensation silicone matrix to replicate the material distribution and thickness for the fabrication of the other matrixes.
a two-step putty wash addition silicone technique was adopted using poly-vinylsiloxane material, 60 Shore A (Aquasil, Dentsply Sirona). First a spacer was applied over the printed waxed cast and the putty silicone was packed inside the previously fabricated vacuum shell. After the setting time advised by the fabricant, the matrix and the spacer were removed from the cast and the light silicone was poured to reline the waxed cast. Once set the PVS-silicone matrix was removed from the vacuum shell and the interproximal areas trimmed using a scalpel. Finally, a layer of resin-based shell (Triad light-curing trays, Dentsply) was applied and cured over the PVS silicone matrix.
Auto-polymerization bisacrylic material (Luxatemp Star, DMG) was used to perform the trial restoration for condensation silicone matrix, addition PVS-silicone matrix with external resin-based shell and CAD/CAM combination matrix. Light-cured flowable composite-resin (Filtek Flow, 3M Dental Products) was used to perform the trial restoration for transparent addition PVS-silicone matrix. The rationale behind using different material stands on the material selection usually chosen by clinicians for each matrix. In the same appointment 4 trial restorations were performed to each patient using the four different matrixes.
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Patients attending the university dental clinic
Universitat Internacional de Catalunya
Barcelona, BARCELONA, 08017, Spain
MIGUEL ROIG CAYON, MD, DDS
Universitat Internacional de Catalunya
20 participants (actual enrollment reported by the registry).
First Submitted
March 21, 2025
First Posted
April 4, 2025
Study Start
January 8, 2023
Actual (reported)the PVS-silicone, 53 Shore A (Elite glass, Zhermack) poured inside the vacuum shell previously fabricated and relined over the waxed cast. After the setting time advised by the fabricant the cast was removed and a hole was performed incisally to each waxed tooth using a bur in order to insert a tip of flowable composite resin.
First, a 3D printed resin matrix was designed (Exocad DentalCAD; Exocad GmbH) and printed (Phrozen Mini 4K, Phrozen Technology) using a clear biocompatible resin (Dental Clear, Harz Labs) providing a calibrated and equally distributed space for the PVS-silicone material, which reproduced the diagnostic waxed design. Later a low-shore PVS-silicone material, 60 Shore A (Aquasil light, Dentsply Sirona) was used to reline the AM matrix. The rigid matrix would guide the relining process thanks to dental-supported distal stops and buccal openings for visual assessment of proper fitting.
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Primary Completion
June 22, 2023
Actual (reported)Study Completion
November 3, 2023
Actual (reported)Last Updated
April 4, 2025
Record last verified: 2024-01
All documentation of the study will be included in a publication planned to be published at the end of the study. After that, all the information (study protocol, informed consent, results) will be uploaded in a public repository from UIC
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Source: ClinicalTrials.gov.
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