Edentulism CompleteNCT07787715
3D Metrology-Based Comparison of Functional Casts Made With Conventional and 3D-Printed Custom Trays
A study testing Conventional PMMA Custom Tray and 3D-Printed Custom Tray in people with Edentulism Complete, run by University of Sao Paulo.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Edentulism Complete
- What is being tested?
- Conventional PMMA Custom Tray and 3D-Printed Custom Tray
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with stable systemic conditions.
- Completely edentulous maxillary patients.
- Residual ridges classified as normal according to Tamaki (1983).
Who cannot join
- Recent tooth extraction, defined as extraction within the previous 6 months.
- High or severely resorbed residual ridges.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 3D Metrology-Based Comparison of Functional Casts Made With Conventional Custom Trays and 3D-Printed Custom Trays in Completely Edentulous Maxillary Patients
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.
Read the detailed description
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.
- Conditions
- Edentulism Complete
- Being tested
- Conventional PMMA Custom Tray, 3D-Printed Custom Tray
- Keywords
- complete denture, 3d printed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional PMMA Custom TrayDiagnostic test
Also called Conventional Custom Tray, PMMA
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.
3D-Printed Custom TrayDiagnostic test
Also called PET-G
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Conventional PMMA Custom Tray; Diagnostic Test: 3D-Printed Custom Tray |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: After completion of both functional impressions, up to 4 weeks after the first functional impression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulism CompleteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ricardo Jun Furuyama, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07787715
- Sponsor's protocol ID
- 95979626.9.0000.0075
- Status last verified
- Aug 2026
- First submitted
- 14 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified individual participant data will not be made publicly available because the study includes a small clinical sample and associated digital maxillary cast files. Although direct identifiers will be removed, the combination of clinical and digital data may create a potential risk of participant re-identification. Aggregated data supporting the published results will be reported in scientific publications.
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D Metrology-Based Comparison of Functional Casts Made With Conventional Custom Trays and 3D-Printed Custom Trays in Completely Edentulous Maxillary Patients
- ClinicalTrials.gov ID
- NCT07787715
- Acronym / sponsor ID
- 95979626.9.0000.0075
- Conditions
- Edentulism Complete
- Keywords
- complete denture, 3d printed
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 26 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Conventional Custom Tray followed by 3D-printed Tray | Active comparator | Diagnostic Test: Conventional PMMA Custom Tray, Diagnostic Test: 3D-Printed Custom TrayParticipants 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with stable systemic conditions.
- Completely edentulous maxillary patients.
- Residual ridges classified as normal according to Tamaki (1983).
Key exclusion criteria (2 listed)
- Recent tooth extraction, defined as extraction within the previous 6 months.
- High or severely resorbed residual ridges.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional PMMA Custom TrayAlso: Conventional Custom Tray, PMMAParticipants 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. | Diagnostic test | Conventional Custom Tray followed by 3D-printed Tray |
| 3D-Printed Custom TrayAlso: PET-GParticipants 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. | Diagnostic test | Conventional Custom Tray followed by 3D-printed Tray |
Primary outcome
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.
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: No. De-identified individual participant data will not be made publicly available because the study includes a small clinical sample and associated digital maxillary cast files. Although direct identifiers will be removed, the combination of clinical and digital data may create a potential risk of participant re-identification. Aggregated data supporting the published results will be reported in scientific publications.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional PMMA Custom Tray and 3D-Printed Custom Tray in people with Edentulism Complete, run by University of Sao Paulo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ricardo J Furuyama, PhD (+551130917888, junfousp@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.