Clinical Evaluation of a New Printable Denture Base Material

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

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 Overview

• Status: Active, not recruiting
• Conditions: Edentulous Mouth
• Intervention / Treatment: Device: Printable denture base material

• Study Type: Interventional
• Enrollment (Estimated): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Liechtenstein
  • Schaan, Liechtenstein, 9494
    • Ivoclar Vivadent AG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Printable denture base material	Device: Printable denture base material; The newly developed printable denture base material will be used for the production of dentures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rate of failures leading to replacement of denture	number of dentures	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
functional (e.g. retention) properties of the dentures	Evaluated according to adapted FDI criteria (grade 1-4). Lower scores mean a better outcome.	5 years
biological (e.g. plaque accumulation) properties of the dentures	Evaluated according to adapted FDI criteria (grade 1-4). Lower scores mean a better outcome.	5 years
aesthetic (e.g. surface staining) properties of the dentures	Evaluated according to adapted FDI criteria (grade 1-4). Lower scores mean a better outcome.	5 years

Collaborators and Investigators

• Sponsor: Ivoclar Vivadent AG

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2024
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: June 6, 2024
• First Submitted That Met QC Criteria: June 12, 2024
• First Posted (Actual): June 14, 2024

Study Record Updates

• Last Update Posted (Actual): September 26, 2024
• Last Update Submitted That Met QC Criteria: September 24, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Mouth, Edentulous
• Other Study ID Numbers: OTCS 11891315

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No