Clinical Evaluation of a New Printable Denture Base Material

Not Applicable

Recruiting

• Conditions: Edentulous Mouth
• Interventions: Device: Printable denture base material

• Registration Number: NCT06458738
• Lead Sponsor: Ivoclar Vivadent AG

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-06
• Study First Submitted QC: 2024-06-12
• Study First Posted: 2024-06-14
• Study Start: 2024-07
• Last Update Submitted: 2024-07-18
• Last Update Posted: 2024-07-19
• Primary Completion: 2029-12
• Study Completion: 2029-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 22

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Printable denture base material	Printable denture base material	-

Primary Outcome Measures

Name	Time	Method
rate of failures leading to replacement of denture	5 years	number of dentures

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ivoclar Vivadent AG; 🇱🇮 Schaan, Liechtenstein