Clinical Evaluation of a New Printable Denture Base Material

Ivoclar Vivadent

Status: Active, not recruiting

Conditions: Edentulous Mouth

Treatments: Device: Printable denture base material

Study type: Interventional

Funder types: Industry

Identifiers

NCT06458738

OTCS 11891315

Details and patient eligibility

About

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.

Enrollment: 22 estimated patients

Sex: All

Ages: 18 to 84 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

Printable denture base material

Experimental group

Treatment:

Device: Printable denture base material