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Clinical Trials/NCT06458738
NCT06458738Active, not recruitingNot Applicable

Clinical Evaluation of a New Printable Denture Base Material: a Prospective Single-arm Study

Ivoclar Vivadent AG1 site in 1 country22 target enrollmentStarted: July 29, 2024Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
22
Locations
1
Primary Endpoint
rate of failures leading to replacement of denture
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This clinical investigation is conducted to prove the long-term clinical performance of a new printable denture base material. The aim of this study is to assess the failure rate, the quality and functionality of the full dentures made with the printable denture base material over an investigational period of 5 years.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 84 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Age: 18 to 84 years
  • •informed consent signed and understood by the subject
  • •full edentulous patients
  • •a digital design of the dentures is already existing.
  • •ability to visit the clinic in person until the baseline recall

Exclusion Criteria

  • •patient does not wear the dentures regularly
  • •mental health status does not allow reliable feedback
  • •patients with a proven allergy to one of the ingredients (methacrylates) of the materials used
  • •patients with severe systemic diseases
  • •poor oral / denture hygiene
  • •pregnancy

Arms & Interventions

Printable denture base material

Experimental

Intervention: Printable denture base material (Device)

Outcomes

Primary Outcomes

rate of failures leading to replacement of denture

Time Frame: 5 years

number of dentures

Secondary Outcomes

  • functional (e.g. retention) properties of the dentures(5 years)
  • aesthetic (e.g. surface staining) properties of the dentures(5 years)
  • biological (e.g. plaque accumulation) properties of the dentures(5 years)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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