PRINTOW: Occlusal Wear of Denture Teeth in Digitally Fabricated Complete Dentures (Printow)
A Randomized, Double-Blind, Three-Arm Superiority Trial Comparing Occlusal Wear of 3D-Printed, CAD/CAM-Milled, and Prefabricated Denture Teeth in Digitally Fabricated Complete Dentures in Edentulous Patients
Przegląd badań
Status
Warunki
Szczegółowy opis
This is a single-center, prospective, randomized, controlled, double-blind clinical investigation comparing three digitally fabricated complete removable dental prosthesis workflows in edentulous patients. The study will be conducted at the University Clinics of Dental Medicine, University of Geneva.
The study includes adult patients who are completely edentulous in the maxillary and mandibular arches and require new complete removable dental prostheses. Participants may be rehabilitated with either a conventional mandibular complete denture or a mandibular implant overdenture supported by clinically stable implants. This inclusion strategy is intended to improve recruitment feasibility and reflect real-world clinical practice. Mandibular prosthetic status at baseline will be used as a stratification factor during randomization and will be accounted for in the statistical analysis.
A total of 48 participants** will be randomized in a 1:1:1 allocation ratio to one of three treatment groups: fully 3D-printed complete dentures with printed denture base and printed denture teeth; CAD/CAM-milled complete dentures with milled double cross-linked denture teeth; or CAD/CAM-milled complete dentures with prefabricated denture teeth, serving as a clinical benchmark group.
The primary objective is to compare occlusal wear performance of denture teeth between the fabrication workflows. The primary confirmatory comparison will be conducted between the fully 3D-printed workflow and the CAD/CAM-milled double cross-linked workflow. Occlusal wear will be assessed by three-dimensional digital superimposition of intraoral scans acquired at baseline and follow-up visits. The primary endpoint is the average negative deviation of occlusal surfaces at 24 months, representing material loss over time.
> Secondary outcomes include root mean square surface deviation, patient-reported outcomes assessed with the Oral Health Impact Profile for Edentulous Patients and the Denture Satisfaction Index, chewing efficiency, bite force, prosthetic retention, color stability, prosthesis-related costs, maintenance interventions, and prosthetic complications. These outcomes will be assessed according to the study schedule at baseline and during follow-up visits at 12, 24, and 60 months.
Participants and outcome assessors will be blinded to denture fabrication workflow and denture tooth material allocation. Prostheses will be labeled using anonymized codes, and digital files used for wear analysis will be anonymized using participant study ID and time point. Treating clinicians and laboratory personnel will not be blinded due to the nature of the intervention, but they will not be involved in blinded outcome assessment.
All prostheses will be fabricated according to standardized clinical and laboratory procedures using CE-marked medical devices and materials according to the manufacturers' instructions for use. The prosthetic treatment phase will include clinical evaluation, impressions, intermaxillary records, prototype try-in, and delivery of the final prostheses. Follow-up assessments will be performed after prosthesis delivery to evaluate clinical, functional, patient-reported, material-related, and maintenance outcomes.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Najla Chebib, PD Dr med dent
- Numer telefonu: +41223794098
- E-mail: najla.chebib@unige.ch
Kopia zapasowa kontaktu do badania
- Nazwa: Alessio Casucci, Dr Phd
- Numer telefonu: +41223794060
- E-mail: Alessio.Casucci@unige.ch
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: 3D-printed denture base and teeth
Participants receive complete removable dental prostheses fabricated using a fully digital workflow with both the denture base and denture teeth produced by 3D printing.
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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.
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Aktywny komparator: CAD/CAM-Milled Denture Base with Milled Denture Teeth
Complete dentures fabricated with CAD/CAM-milled denture bases and CAD/CAM-milled denture teeth
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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.
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Aktywny komparator: CAD/CAM-Milled Denture Base with Prefabricated Denture Teeth
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.
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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.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Occlusal Wear of Denture Teeth
Ramy czasowe: from baseline to 24 month
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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.
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from baseline to 24 month
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Surface Deviation (Root Mean Square, RMS)
Ramy czasowe: from baseline to 12, 24 and 60 months
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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.
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from baseline to 12, 24 and 60 months
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Maximum Bite Force
Ramy czasowe: at Baseline, 12, 24, and 60 months
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Maximum bite force will be measured using a digital bite force device, expressed in Newtons (N).
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at Baseline, 12, 24, and 60 months
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Chewing Efficiency
Ramy czasowe: at baseline, 12, 24, and 60 months
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Chewing efficiency will be assessed using a standardized two-color mixing test, quantified as variance of hue (VOH).
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at baseline, 12, 24, and 60 months
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Oral Health-Related Quality of Life
Ramy czasowe: at baseline, 12, 24, 60 months
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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.
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at baseline, 12, 24, 60 months
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Denture Satisfaction
Ramy czasowe: at baseline, 12, 24, and 60 months
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Patient satisfaction with dentures will be assessed using a validated questionnaire.
Denture satisfaction will be assessed using a Visual Analog Scale (VAS) ranging from 0 to 10, where 0 indicates no satisfaction and 10 indicates maximum satisfaction.
Higher scores reflect greater patient satisfaction with the prosthesis.
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at baseline, 12, 24, and 60 months
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Denture Retention
Ramy czasowe: at baseline
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Retention of the maxillary denture bases will be assessed by measuring the force required to dislodge the prosthetic base from the denture-bearing tissues.
A digital dynamometer will be attached to a standardized central hook incorporated into the test base.
The base will be seated intraorally, and a controlled vertical traction force will be applied until dislodgement occurs.
The maximum force required to dislodge the base will be recorded in Newtons (N).
Higher values indicate greater denture base retention.
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at baseline
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Color Stability
Ramy czasowe: at baseline, 12, 24, and 60 months
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Color changes of denture teeth will be assessed using colorimetric measurements and expressed as ΔE values.
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at baseline, 12, 24, and 60 months
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Total prosthesis fabrication cost
Ramy czasowe: at baseline,
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Costs related to prosthesis fabrication will be recorded for each study group.
This will include initial laboratory fabrication costs in swiss francs CHF per participant.
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at baseline,
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Number of Prosthetic Maintenance Visits
Ramy czasowe: from baseline to 12, 24, and 60 months
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The number of additional prosthesis-related maintenance visits required after prosthesis delivery will be recorded for each participant.
Maintenance visits may include visits for adjustment, repair, relining, or management of prosthetic complications. it will be measured as the number of prosthetic maintenance visits per participant (NPMV) and cost associated to each visit in Swiss francs (CHF) per participant.
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from baseline to 12, 24, and 60 months
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Incidence of Prosthetic Complications
Ramy czasowe: From baseline to 12 months, 24 months, and 60 months
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Prosthetic complications will be recorded as the number and percentage of participants experiencing at least one clinically relevant complication during follow-up.
Complications may include denture base fracture, tooth detachment, prosthesis damage, loss of retention requiring intervention, relining, repair, or prosthesis remake/replacement.
Each event will be documented by type and timing.
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From baseline to 12 months, 24 months, and 60 months
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Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Najla Chebib, Dr med dent, University of Geneva, Switzerland
- Główny śledczy: Alessio Casucci, University of Geneva, Switzerland
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- Printow sso grant 370-25
- 370-25 (Inny numer grantu/finansowania: Swiss society of odontology)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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