Comparison of Trial Restoration Matrix Fabrication Methods

NCT06912503 | Completed

• 1 other identifier: REST-ECL-2020-03
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Teeth Restoration

Keywords

Restoration of worn teeth

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Condensation silicone matrix

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.

Device: Device to deliver trial restoration matrix

Addition PVS-silicone matrix

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.

Device: Device to deliver trial restoration matrix

Transparent addition PVS-silicone matrix

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.

Device: Device to deliver trial restoration matrix

CAD/CAM combination matrix

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.

Device: Device to deliver trial restoration matrix

Interventions

Device to deliver trial restoration matrix DEVICE

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.

Addition PVS-silicone matrix; CAD/CAM combination matrix; Condensation silicone matrix; Transparent addition PVS-silicone matrix

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients attending the university dental clinic

You may not qualify if:

• Patients with removable prostheses.
• Patients with an absent upper anterior tooth.
• Patients with a buccal inclination of any of the six upper anterior teeth.

Sponsors & Collaborators

• Universitat Internacional de Catalunya: lead

Study Sites (1)

Universitat Internacional de Catalunya

Barcelona, BARCELONA, 08017, Spain

Location

Study Officials

• MIGUEL ROIG CAYON, MD, DDS

  Universitat Internacional de Catalunya

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2025
• First Posted: April 4, 2025
• Study Start: January 8, 2023
• Primary Completion: June 22, 2023
• Study Completion: November 3, 2023
• Last Updated: April 4, 2025

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Start date: September 2025
• Access Criteria: Open access

Locations

ES (1)