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
Tutkimuksen yleiskatsaus
Tila
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Najla Chebib, PD Dr med dent
- Puhelinnumero: +41223794098
- Sähköposti: najla.chebib@unige.ch
Tutki yhteystietojen varmuuskopiointi
- Nimi: Alessio Casucci, Dr Phd
- Puhelinnumero: +41223794060
- Sähköposti: Alessio.Casucci@unige.ch
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Kaksinkertainen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: 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.
|
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.
|
|
Active Comparator: CAD/CAM-Milled Denture Base with Milled Denture Teeth
Complete dentures fabricated with CAD/CAM-milled denture bases and CAD/CAM-milled denture teeth
|
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.
|
|
Active Comparator: 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.
|
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.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Occlusal Wear of Denture Teeth
Aikaikkuna: from baseline to 24 month
|
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
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Surface Deviation (Root Mean Square, RMS)
Aikaikkuna: from baseline to 12, 24 and 60 months
|
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.
|
from baseline to 12, 24 and 60 months
|
|
Maximum Bite Force
Aikaikkuna: at Baseline, 12, 24, and 60 months
|
Maximum bite force will be measured using a digital bite force device, expressed in Newtons (N).
|
at Baseline, 12, 24, and 60 months
|
|
Chewing Efficiency
Aikaikkuna: at baseline, 12, 24, and 60 months
|
Chewing efficiency will be assessed using a standardized two-color mixing test, quantified as variance of hue (VOH).
|
at baseline, 12, 24, and 60 months
|
|
Oral Health-Related Quality of Life
Aikaikkuna: at baseline, 12, 24, 60 months
|
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.
|
at baseline, 12, 24, 60 months
|
|
Denture Satisfaction
Aikaikkuna: at baseline, 12, 24, and 60 months
|
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.
|
at baseline, 12, 24, and 60 months
|
|
Denture Retention
Aikaikkuna: at baseline
|
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.
|
at baseline
|
|
Color Stability
Aikaikkuna: at baseline, 12, 24, and 60 months
|
Color changes of denture teeth will be assessed using colorimetric measurements and expressed as ΔE values.
|
at baseline, 12, 24, and 60 months
|
|
Total prosthesis fabrication cost
Aikaikkuna: at baseline,
|
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.
|
at baseline,
|
|
Number of Prosthetic Maintenance Visits
Aikaikkuna: from baseline to 12, 24, and 60 months
|
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.
|
from baseline to 12, 24, and 60 months
|
|
Incidence of Prosthetic Complications
Aikaikkuna: From baseline to 12 months, 24 months, and 60 months
|
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.
|
From baseline to 12 months, 24 months, and 60 months
|
Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Päätutkija: Najla Chebib, Dr med dent, University of Geneva, Switzerland
- Päätutkija: Alessio Casucci, University of Geneva, Switzerland
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- Printow sso grant 370-25
- 370-25 (Muu apuraha/rahoitusnumero: Swiss society of odontology)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .