PRINTOW: Occlusal Wear of Denture Teeth in Digitally Fabricated Complete Dentures
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNajla Chebib
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
CAD/CAM-Milled Denture Base with Milled Denture Teeth
DeviceComplete 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 Prefabricated Denture Teeth
DeviceComplete 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.
3D-printed denture base and teeth
DeviceDescription 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.
Treatment groups
45 Participants
are divided into 3 treatment groupsGroup A: 3D-printed denture base and teethExperimental treatment 1 intervention
Group B: CAD/CAM-Milled Denture Base with Milled Denture TeethActive comparator 1 intervention
Group C: CAD/CAM-Milled Denture Base with Prefabricated Denture TeethActive comparator 1 intervention
Trial outcomes
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.
Time frame
from baseline to 24 monthSecondary outcomes
1
Surface Deviation (Root Mean Square, RMS)
Surface deviation will be quantified using root mean square (RMS) values derived from three-dimensional superimposition of intraoral scans, providing a global measure of surface change.
Time frame
from baseline to 12, 24 and 60 months2
Maximum Bite Force
Maximum bite force will be measured using a digital bite force device, expressed in Newtons (N).
Time frame
at Baseline, 12, 24, and 60 months3
Chewing Efficiency
Chewing efficiency will be assessed using a standardized two-color mixing test, quantified as variance of hue (VOH).
Time frame
at baseline, 12, 24, and 60 months4
Oral Health-Related Quality of Life
Patient-reported oral health-related quality of life will be assessed using the OHIP-EDENT questionnaire. The OHIP-EDENT questionnaire consists of 19 items assessing oral health-related quality of life in edentulous patients. Each item is scored on a 5-point Likert scale (0 = never to 4 = very often), with a total score ranging from 0 to 76. Higher scores indicate worse oral health-related quality of life.
Time frame
at baseline, 12, 24, 60 monthsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Najla Chebib
Lead sponsor
University of Geneva, Switzerland
Sponsor institution
Source ClinicalTrials.gov
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