NCT06458738

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
43mo left

Started Jul 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress33%
Jul 2024Dec 2029

First Submitted

Initial submission to the registry

June 6, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 14, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

July 29, 2024

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

September 26, 2024

Status Verified

September 1, 2024

Enrollment Period

5.3 years

First QC Date

June 6, 2024

Last Update Submit

September 24, 2024

Conditions

Edentulous Mouth

Outcome Measures

Primary Outcomes (1)

  • rate of failures leading to replacement of denture

    number of dentures

    5 years

Secondary Outcomes (3)

  • functional (e.g. retention) properties of the dentures

    5 years

  • biological (e.g. plaque accumulation) properties of the dentures

    5 years

  • aesthetic (e.g. surface staining) properties of the dentures

    5 years

Study Arms (1)

Printable denture base material

EXPERIMENTAL
Device: Printable denture base material

Interventions

Printable denture base materialDEVICE

The newly developed printable denture base material will be used for the production of dentures.

Printable denture base material

Eligibility Criteria

Age18 Years - 84 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ivoclar Vivadent AG

Schaan, Liechtenstein, 9494, Liechtenstein

Location

MeSH Terms

Conditions

Mouth, Edentulous

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesTooth Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2024

First Posted

June 14, 2024

Study Start

July 29, 2024

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2029

Last Updated

September 26, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

LI(1)