3D Metrology-Based Comparison of Functional Casts Made With Conventional and 3D-Printed Custom Trays

NCT07787715 | Not Yet Recruiting DMC

• 1 other identifier: 95979626.9.0000.0075
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will compare the dimensional discrepancies of functional casts obtained using conventional custom trays and 3D-printed custom trays made from PET-G (Polyethylene Terephthalate Glycol) filament. Thirty completely edentulous maxillary patients treated in the Complete Denture Course at the School of Dentistry, University of São Paulo (FOUSP), will be evaluated. Anatomical casts will be obtained, digitized, and used to fabricate conventional or digitally designed and 3D-printed custom trays. Functional impressions will then be made with zinc-oxide eugenol impression paste, and the resulting functional casts will be fabricated in Type III gypsum. The casts will be digitized and compared using 3D metrology software. Measurements will be obtained at standardized anatomical regions, including the bilateral tuberosity regions, incisive papilla, palatine raphe, and four vestibular points.

Conditions

Edentulism Complete

Keywords

complete denture; 3d printed

Outcome Measures

Primary Outcomes (1)

• Three-dimensional discrepancy between functional-cast STL meshes

  Difference between the STL meshes of the functional casts obtained using conventional PMMA custom trays and the functional casts obtained using PET-G filament 3D-printed custom trays. Mesh discrepancy will be quantified in ZEISS Inspect software using standardized anatomical measurement points. The measurements will be performed using the deviation label tool (inspect\>deviation label) and collected in mm. The measurement locations will include the bilateral tuberosity regions, palatine raphe region, incisive papilla region, and four vestibular points.

  After completion of both functional impressions, up to 4 weeks after the first functional impression.

Secondary Outcomes (1)

• Regional three-dimensional mesh discrepancy at standardized anatomical points

  After completion of both functional impressions, up to 4 weeks after the first functional impression

Study Arms (1)

Conventional Custom Tray followed by 3D-printed Tray

ACTIVE COMPARATOR

Participants will receive a functional maxillary impression using a custom tray fabricated from chemically activated polymethyl methacrylate (PMMA) acrylic resin and a functional maxillary impression using a digitally designed custom tray fabricated by three-dimensional printing with polyethylene terephthalate glycol (PET-G) filament. Functional impressions will be obtained using zinc oxide-eugenol impression paste.

Diagnostic Test: Conventional PMMA Custom Tray; Diagnostic Test: 3D-Printed Custom Tray

Interventions

Conventional PMMA Custom Tray DIAGNOSTIC_TEST

Participants or casts associated with the conventional technique will be evaluated. The anatomical model will be delineated according to the FOUSP Complete Denture Course and isolated with a gypsum-resin separator. Chemically activated PMMA acrylic resin will be manipulated at a ratio of 15 cc powder to 5 cc liquid, adapted to the model in the plastic phase, and finished and polished after complete polymerization.

Also known as: Conventional Custom Tray, PMMA

Conventional Custom Tray followed by 3D-printed Tray

3D-Printed Custom Tray DIAGNOSTIC_TEST

Participants or casts associated with the printed technique will be evaluated. The custom tray will be digitally designed using inLab software with a thickness of 3 mm and zero spacing. The STL file will be printed on an Adventurer 4 Pro printer using CREALITY CR-PETG thermoplastic filament, according to the manufacturer's parameters. The tray will then be finished and polished.

Also known as: PET-G

Conventional Custom Tray followed by 3D-printed Tray

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with stable systemic conditions.
• Completely edentulous maxillary patients.
• Residual ridges classified as normal according to Tamaki (1983).

You may not qualify if:

• Recent tooth extraction, defined as extraction within the previous 6 months.
• High or severely resorbed residual ridges.

Sponsors & Collaborators

• University of Sao Paulo: lead

Central Study Contacts

Ricardo J Furuyama, PhD

CONTACT

+551130917888; junfousp@usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This is a non-randomized, two-period, within-participant clinical trial. Each participant will receive functional impressions using both custom tray fabrication techniques: a conventional chemically activated PMMA custom tray and a digitally designed PET-G filament 3D-printed custom tray. Functional casts obtained after each impression procedure will be digitized and compared by 3D metrology. Each participant will serve as their own control.

Study Record Dates

• First Submitted: August 14, 2026
• First Posted: August 26, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: August 26, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share