PRINTOW: Occlusal Wear of Denture Teeth in Digitally Fabricated Complete Dentures

NCT07585162 | Not Yet Recruiting

• 2 other identifiers: Printow sso grant 370-25370-25
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief Summary

This randomized controlled trial evaluates the occlusal wear of denture teeth fabricated using three digital workflows: 3D-printed denture teeth, CAD/CAM-milled double cross-linked denture teeth, and prefabricated denture teeth. Occlusal wear will be assessed over 24 months using digital superimposition techniques. The study aims to determine whether 3D-printed denture teeth demonstrate superior wear resistance compared to CAD/CAM-milled denture teeth.

Conditions

Edentulism Complete; Edentulism

Keywords

Edentulism; Complete dentures; Digital dentistry; 3D printing; CAD/CAM; Occlusal wear; Denture teeth; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Occlusal Wear of Denture Teeth

  Occlusal wear of denture teeth will be assessed using three-dimensional digital superimposition of intraoral scans acquired at baseline and follow-up visits. Wear will be quantified as the average negative deviation (-AVG) between superimposed surfaces, expressed in micrometers (µm), representing material loss over time.

  from baseline to 24 month

Secondary Outcomes (10)

• Surface Deviation (Root Mean Square, RMS)

  from baseline to 12, 24 and 60 months

• Maximum Bite Force

  at Baseline, 12, 24, and 60 months

• Chewing Efficiency

  at baseline, 12, 24, and 60 months

• Oral Health-Related Quality of Life

  at baseline, 12, 24, 60 months

• Denture Satisfaction

  at baseline, 12, 24, and 60 months

Study Arms (3)

3D-printed denture base and teeth

EXPERIMENTAL

Participants receive complete removable dental prostheses fabricated using a fully digital workflow with both the denture base and denture teeth produced by 3D printing.

Device: 3D-printed denture base and teeth

CAD/CAM-Milled Denture Base with Milled Denture Teeth

ACTIVE COMPARATOR

Complete dentures fabricated with CAD/CAM-milled denture bases and CAD/CAM-milled denture teeth

Device: CAD/CAM-Milled Denture Base with Milled Denture Teeth

CAD/CAM-Milled Denture Base with Prefabricated Denture Teeth

ACTIVE COMPARATOR

Participants receive complete removable dental prostheses fabricated using a digital workflow with CAD/CAM-milled denture bases and conventionally manufactured prefabricated denture teeth. Conventional clinical reference.

Device: CAD/CAM-Milled Denture Base with Prefabricated Denture Teeth

Interventions

CAD/CAM-Milled Denture Base with Milled Denture Teeth DEVICE

Complete removable dental prostheses fabricated using a digital workflow with CAD/CAM milling. Both the denture base and denture teeth are produced by subtractive manufacturing from pre-polymerized resin materials, including double cross-linked denture teeth, and assembled.

CAD/CAM-Milled Denture Base with Milled Denture Teeth

CAD/CAM-Milled Denture Base with Prefabricated Denture Teeth DEVICE

Complete removable dental prostheses fabricated using a digital workflow with CAD/CAM-milled denture bases combined with conventionally manufactured prefabricated denture teeth. The prefabricated teeth are selected and positioned digitally or manually and then bonded to the milled denture base.

CAD/CAM-Milled Denture Base with Prefabricated Denture Teeth

3D-printed denture base and teeth DEVICE

Description Complete removable dental prostheses fabricated using a fully digital workflow in which both the denture base and denture teeth are produced by 3D printing using light-curing resin materials. The prostheses are designed digitally and manufactured additively.

3D-printed denture base and teeth

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent provided by the participant
• Age ≥ 18 years
• Fully edentulous maxilla and mandible requiring rehabilitation with new complete removable dental prostheses
• Patients with or without mandibular implants (implant overdenture or conventional denture)
• Clinical indication for fabrication of new maxillary and mandibular complete removable dental prostheses
• Currently wearing complete dentures, or a maxillary denture combined with a mandibular denture or overdenture
• Ability and willingness to attend all scheduled follow-up visits for the duration of the study

You may not qualify if:

• Contraindications to the medical devices used, e.g. known hypersensitivity or allergy;
• Known or suspected non-compliance, drug or alcohol abuse; Inability to follow the procedures of the investigation;
• Enrolment of the investigator, his/her family members, employees and other dependent persons;
• Reported severe bruxism or clenching habits, identified through patient interview and clinical examination, including self-reported grinding or clenching, partner reports, morning jaw discomfort, and other signs of parafunctional activity;
• Width of the edentulous maxilla \>80 mm;
• Width of the edentulous mandible \>80 mm; Vertical prosthetic space \<38 mm (maxilla or mandible);
• Depression: Geriatric Depression Scale \>9;
• Xerostomia: UFR ≤ 0.2ml/2min;
• Dementia: Clock-Drawing Test ≤5;
• Active peri-implant disease or instability of the two mandibular implants at baseline when implants are present;
• Presence of an implant-retained prosthesis in the maxilla;
• Planned implant-related surgical intervention during the study period.

Sponsors & Collaborators

• Najla Chebib: lead

MeSH Terms

Conditions

Tooth Attrition

Condition Hierarchy (Ancestors)

Tooth Wear; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Najla Chebib, Dr med dent

  University of Geneva, Switzerland

  PRINCIPAL INVESTIGATOR

• Alessio Casucci

  University of Geneva, Switzerland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Najla Chebib, PD Dr med dent

CONTACT

+41223794098; najla.chebib@unige.ch

Alessio Casucci, Dr Phd

CONTACT

+41223794060; Alessio.Casucci@unige.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: This study is double-blind. Participants and outcome assessors are blinded to the allocation of denture tooth material. All prostheses are fabricated externally and labeled using anonymized codes to conceal the fabrication method aand type of denture teeth used. The external appearance of the prostheses is standardized to prevent identification of the material. Digital files used for outcome assessment (wear analysis) are anonymized and coded by study ID and timepoint, ensuring that outcome assessors remain blinded throughout the analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PD Dr

Model Details: Participants are randomized in a 1:1:1 ratio to one of three parallel groups receiving complete dentures fabricated with different denture tooth materials (3D-printed, CAD/CAM-milled, or prefabricated).

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: May 13, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 30, 2031
• Study Completion (Estimated): December 30, 2032
• Last Updated: May 13, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share