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Clinical Outcomes of 3D Printed and Milled Complete Dentures

15. september 2026 oppdatert av: Dentsply Sirona Implants and Consumables

An Open, Single-center, Prospective, Randomized, Two-armed, Interventional, Post-market Clinical Investigation of 3D Printed Complete Dentures and Milled Complete Dentures During a 5-year Follow-up Period

This is a two-armed, single-center clinical study evaluating performance, efficacy and safety of three dimensional (3D) printed complete dentures and milled complete dentures during a 5-year follow-up period. The primary objective of this clinical investigation is to evaluate survival rate, i.e. subjects with survived dentures in both upper and lower jaw, of 3D printed complete dentures and milled complete dentures after 1 year (in each of the groups separately).

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

68

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Forente stater
    • North Carolina
      • Chapel Hill, North Carolina, Forente stater, 27599
        • Rekruttering
        • Adams School of Dentistry
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • Adult aged 18 years or above at time of informed consent.
  • Subject willing to participate in the clinical investigation and able to understand the content of the clinical investigation.
  • Subject willing to comply with investigational related procedures and to return for follow-up visits for a period of 5 years.
  • Subject has signed and dated the informed consent form.
  • Subjects in need of complete dentures in maxilla and mandible.
  • Prosthodontic Diagnostic Index (PDI) Completely edentulous classification (Class 1-3).
  • History of edentulism of at least 1 year.

Exclusion Criteria:

  • Known allergy or hypersensitivity to any of the components.
  • Subjects with significant systemic health issues or chronic conditions (American Society of Anesthesiologists (ASA) class 3-6 ).
  • Known pregnancy at time of enrolment.
  • Subjects unlikely to comply with investigational procedures, or unlikely to come back for follow-up visits, as judged by the Investigator.
  • Previous enrolment in the present clinical investigation.
  • Involvement in the planning and conduct of the clinical investigation (applies to both Dentsply Sirona personnel and the clinical investigation site).

  • PDI Completely edentulous classification (Class 4)

    • Presence of severely atrophied ridge.
    • Presence of severe ridge undercuts.
    • Clinically severe Xerostomia.
    • Absence of hard or soft tissue pathology that precludes denture therapy.
    • Maxillofacial defects.
  • Uncontrolled pathological process in the oral cavity, as judged by the Investigator.
  • Participation in another clinical investigation that may interfere with the present clinical investigation.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 3D printed dentures
3D printed denture bases and 3D printed denture teeth.
Enhet: Lucitone Digital Print

Consisting of the following parts:

  • Lucitone Digital Print 3D Denture Base.
  • Lucitone Digital Interpenetrating Polymer Network (IPN) 3D Premium Tooth.
  • Lucitone Digital Print Denture System Accessories
Eksperimentell: Milled dentures
Milled denture bases and denture teeth.
Enhet: Lucitone Digital Fit

Consisting of the following parts:

  • Lucitone Digital Fit Denture Discs.
  • Dentsply Sirona Multilayer Polymethyl Methacrylate (PMMA) Discs.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Denture survival rate
Tidsramme: One year after baseline (baseline = final denture insertion performed within 6-months from day 1)
Restorations still in function after 1 year.
One year after baseline (baseline = final denture insertion performed within 6-months from day 1)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Denture survival rate
Tidsramme: 3 and 6 months, and 2, 3, 4 and 5 years after baseline (baseline = final denture insertion performed within 6-months from day 1)
Restorations still in function after 3 and 6 months, and 2, 3, 4 and 5 years.
3 and 6 months, and 2, 3, 4 and 5 years after baseline (baseline = final denture insertion performed within 6-months from day 1)
Denture success
Tidsramme: 3 and 6 months, and 1, 2, 3, 4 and 5 years after baseline (baseline = final denture insertion performed within 6-months from day 1)

A denture will be considered successful if all the following criteria are fulfilled:

Absence of major technical complications.

Absence of major biological complications.

Functional occlusion and mastication, assessed by clinical examination and OHIP-EDENT.

  • Assessed by OHIP-EDENT - Q1 from OHIP: "Have you had difficulty chewing any foods because of problems with your teeth, mouth or dentures?", where score 0-2 would be considered successful (0=never, 1=hardly ever, 2 = occasionally).

Absence of patient reported discomfort, assessed by OHIP-EDENT.

  • Assessed by all questions in Physical pain section of OHIP-EDENT - Q4 "Have you had painful aching in your mouth?", Q5 "Have you found it uncomfortable to eat any foods because of problems with your teeth, mouth or dentures?", Q6 "Have you had sore spots in your mouth?, Q7 "Have you had uncomfortable dentures?", where score 0-1 would be considered successful (0=never and 1=hardly ever).
3 and 6 months, and 1, 2, 3, 4 and 5 years after baseline (baseline = final denture insertion performed within 6-months from day 1)
Denture adaptation accuracy
Tidsramme: At baseline (baseline = final denture insertion performed within 6-months from day 1)
Evaluation of accuracy of 3D printing and milling technology will be made using Geomagic Software at time of final denture insertion. The denture intaglio at insertion will be compared with the final impression as reference scan.
At baseline (baseline = final denture insertion performed within 6-months from day 1)
Denture retention force
Tidsramme: 3 and 6 months, and 1, 2, 3, 4 and 5 years after baseline (baseline = final denture insertion performed within 6-months from day 1)
Retention force of the dentures will be evaluated by applying a dynamometer gauge at the following locations: Post dam, Tuberosities and retromolar pads.
3 and 6 months, and 1, 2, 3, 4 and 5 years after baseline (baseline = final denture insertion performed within 6-months from day 1)
Technical Complications
Tidsramme: At baseline, 3 and 6 months, and 1, 2, 3, 4 and 5 years after baseline (baseline = final denture insertion performed within 6-months from day 1)

Complications will be recorded and assessed as either:

  • Major complications (requiring laboratory intervention to correct - fracture, lab reline, etc.).
  • Minor complications (requiring chairside adjustment - sore spots, occlusal discrepancies, etc.).
At baseline, 3 and 6 months, and 1, 2, 3, 4 and 5 years after baseline (baseline = final denture insertion performed within 6-months from day 1)
Biological Complications
Tidsramme: At baseline, 3 and 6 months, and 1, 2, 3, 4 and 5 years after baseline (baseline = final denture insertion performed within 6-months from day 1)
Occurrence of biological complications. Biological complications will be evaluated by recording major and minor biological complications. The evaluation of biological complications will be derived from the adverse event (AE)/adverse device effect (ADE) sections of the Case Report Form.
At baseline, 3 and 6 months, and 1, 2, 3, 4 and 5 years after baseline (baseline = final denture insertion performed within 6-months from day 1)
OHIP-EDENT Questionnaire.
Tidsramme: 3 and 6 months, and 1, 2, 3, 4 and 5 years after baseline (baseline = final denture insertion performed within 6-months from day 1)
Quality of Life through Oral Health Impact Profile for Edentulous Patients (OHIP-EDENT) Questionnaire completed by participating subjects. OHIP-EDENT contains 19 questions, divided into six domains: Functional limitations, Physical pain, Psychological discomfort, Physical disability, Psychological disability and Handicap. Response categories for all questions: 4 = very often; 3 = fairly often; 2 = occasionally; 1 = hardly ever; 0=never, i.e. lower scores corresponds with higher quality of life.
3 and 6 months, and 1, 2, 3, 4 and 5 years after baseline (baseline = final denture insertion performed within 6-months from day 1)
Denture quality assessed via volumetric loss
Tidsramme: At baseline and 3 and 6 months, 1, 2, 3, 4 and 5 years after baseline (baseline = final denture insertion performed within 6-months from day 1)
Serial comparison of follow-up denture scans using TRIOS Compare with post insertion adjusted denture scan as reference. Volumetric loss measured in mm3.
At baseline and 3 and 6 months, 1, 2, 3, 4 and 5 years after baseline (baseline = final denture insertion performed within 6-months from day 1)
Denture quality assessed via maximum vertical loss.
Tidsramme: At baseline and 3 and 6 months, 1, 2, 3, 4 and 5 years after baseline (baseline = final denture insertion performed within 6-months from day 1)
Serial comparison of follow-up denture scans using TRIOS Compare with post insertion adjusted denture scan as reference. Maximum vertical loss measured in μm.
At baseline and 3 and 6 months, 1, 2, 3, 4 and 5 years after baseline (baseline = final denture insertion performed within 6-months from day 1)
Denture quality assessed by discolouration (delta E) at a central incisor (#8).
Tidsramme: At baseline and 3 and 6 months, 1, 2, 3, 4 and 5 years after baseline (baseline = final denture insertion performed within 6-months from day 1)
Discolouration (intrinsic or interfacial) measured with spectrophotometer. The colour at a central incisor (#8) and the denture just above #8 will be measured.
At baseline and 3 and 6 months, 1, 2, 3, 4 and 5 years after baseline (baseline = final denture insertion performed within 6-months from day 1)
Denture quality assessed by occlusion (bite position).
Tidsramme: At baseline and 3 and 6 months, 1, 2, 3, 4 and 5 years after baseline (baseline = final denture insertion performed within 6-months from day 1)
Number of occlusal contacts using articulating paper will be documented.
At baseline and 3 and 6 months, 1, 2, 3, 4 and 5 years after baseline (baseline = final denture insertion performed within 6-months from day 1)
Denture aesthetics - Appropriateness of tooth shape.
Tidsramme: At baseline (baseline = final denture insertion performed within 6-months from day 1)

Appropriateness of tooth shape assessed by the following Yes/No question:

Appropriate Tooth Shape to match facial aesthetics?
At baseline (baseline = final denture insertion performed within 6-months from day 1)
Denture aesthetics - Appropriateness of tooth size.
Tidsramme: At baseline (baseline = final denture insertion performed within 6-months from day 1)

Appropriateness of tooth size assessed by the following Yes/No question:

Appropriate Tooth Size to match facial aesthetics?
At baseline (baseline = final denture insertion performed within 6-months from day 1)
Denture aesthetics - Appropriateness of tooth arrangement
Tidsramme: At baseline (baseline = final denture insertion performed within 6-months from day 1)

Appropriateness of tooth arrangements assessed by the following Yes/No questions:

  • Overall tooth position, angulation and alignment that appears natural and pleasing?
  • Posterior tooth alignment to maintain adequate buccal corridors?
  • Dental midline aligned in relation to facial midline?
  • Appropriate orientation of occlusal plane in relation to patient's smile line and facial reference lines?
  • Sufficient horizontal overlap?
At baseline (baseline = final denture insertion performed within 6-months from day 1)
Denture aesthetics - Appropriateness of tooth colour / colour match
Tidsramme: At baseline (baseline = final denture insertion performed within 6-months from day 1)

Appropriateness of tooth colour /colour match assessed by the following Yes/No questions:

  • Appropriate Tooth Shade to suit the naturalness of the patient's skin tone?
  • Appropriate Gingival Shade, translucency and colour characterisation to suit the naturalness of the patient's original gingiva?
At baseline (baseline = final denture insertion performed within 6-months from day 1)
Denture aesthetics - Appropriateness of Denture base
Tidsramme: At baseline (baseline = final denture insertion performed within 6-months from day 1)

Appropriateness of denture base assessed by the following Yes/No questions:

  • Appropriate tooth to gingival display?
  • Appropriate physical characterisation (contours) of denture base that appears natural and pleasing?
At baseline (baseline = final denture insertion performed within 6-months from day 1)
Denture aesthetics - Lip support
Tidsramme: At baseline (baseline = final denture insertion performed within 6-months from day 1)

Lip support assessed by the following Yes/No questions:

  • Anterior tooth alignment to provide adequate lip support when viewed from the facial profile?
  • Appropriate arch form to allow for natural facial expressions and phonetics?
  • Thickness of denture flange for adequate lip support and facial expressions?
At baseline (baseline = final denture insertion performed within 6-months from day 1)
Occurrence of Adverse Events, Adverse Device Effects, and Device Deficiencies during the clinical investigation.
Tidsramme: From Day 0 up to completion of the 5-year follow-up visit, on average 5 years and 3 months.
Adverse Events, Adverse Device Effects, and Device Deficiencies spontaneously reported, and collection at each clinical investigation visit.
From Day 0 up to completion of the 5-year follow-up visit, on average 5 years and 3 months.
Patient Satisfaction
Tidsramme: 3 and 6 months, and 1, 2, 3, 4 and 5 years after baseline (baseline = final denture insertion performed within 6-months from day 1)

Patient satisfaction including aesthetics as evaluated by patient questionnaire including the following questions:

  1. Are you overall satisfied with your dentures?
  2. Are your satisfied with the comfort of your dentures?
  3. Are you satisfied with the aesthetics of your dentures?
  4. Are you satisfied with your ability to speak when wearing your dentures?
  5. Are you satisfied with the fit of your dentures?

Patient satisfaction with dentures will be evaluated using a likert scale, ranging from 0 to 10 for each of above questions. The likert scale representing a spectrum of feelings between extremes with 0= Very unsatisfied and 10= Very satisfied. Patients will rate their assessment by marking a number corresponding to their feelings at the time. A low score represents a high degree of dissatisfaction, and a high score a high degree of satisfaction
3 and 6 months, and 1, 2, 3, 4 and 5 years after baseline (baseline = final denture insertion performed within 6-months from day 1)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Dentsply Sirona Implants and Consumables

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

11. september 2026

Primær fullføring (Antatt)

30. oktober 2028

Studiet fullført (Antatt)

30. oktober 2032

Datoer for studieregistrering

Først innsendt

30. mars 2026

Først innsendt som oppfylte QC-kriteriene

7. mai 2026

Først lagt ut (Faktiske)

14. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

17. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

15. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • C-LA-24-020

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

produkt produsert i og eksportert fra USA

Nei

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