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NCT Number: NCT07787715

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

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.

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Key information

Conditions

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Complete denture fabrication commonly relies on long-established conventional techniques. Custom trays are conventionally fabricated with chemically activated polymethyl methacrylate (PMMA) acrylic resin. Digital dentistry and additive manufacturing may provide alternative methods and materials for custom-tray fabrication, including PET-G (Polyethylene Terephthalate Glycol) filament.

In this study, functional casts obtained using conventional custom trays will be compared with functional casts obtained using digitally designed and 3D-printed custom trays. Anatomical casts will be made according to the anatomical impression technique fabricated in Type II gypsum, and digitized with an INEOS X5 bench scanner. The digital models will be processed in inLab software to remove undercuts and define the basal area outline.

For the conventional group, custom trays will be fabricated with chemically activated PMMA acrylic resin. For the printed group, custom trays will be digitally designed with a thickness of 3 mm and zero spacing, exported as STL files, and printed on an Adventurer 4 Pro printer using CREALITY CR-PETG thermoplastic filament, according to the manufacturer's parameters.

Functional impressions will be obtained using the technique recommended by the FOUSP Complete Denture Course and zinc-oxide eugenol impression paste. Functional casts will be fabricated in Type III gypsum, scanned, and exported as STL (Standard Triangle Language) files. The meshes will be compared in ZEISS Inspect software to quantify discrepancies between the test and reference meshes.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

Other names: Conventional Custom Tray, PMMA

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.

Other names: PET-G

Primary outcomes

  1. Three-dimensional discrepancy between functional-cast STL meshes

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

    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.

Secondary outcomes

  1. Regional three-dimensional mesh discrepancy at standardized anatomical points

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

    Regional differences between the STL meshes will be measured at eight standardized points: two points in the tuberosity regions, one point in the palatine raphe region, one point in the incisive papilla region, and four vestibular points.

Study contacts

Contact information is provided by the study sponsor or research team.

Ricardo J Furuyama, PhD

CONTACT

[email protected]

+551130917888

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

3D Metrology-Based Comparison of Functional Casts Made With Conventional Custom Trays and 3D-Printed Custom Trays in Completely Edentulous Maxillary Patients

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 26, 2026
Registry last updated
Aug 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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