Clinical Evaluation of a New Printable Denture Base Material

Edentulous Mouth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06458738
• Other study ID #: OTCS 11891315
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2024
• Est. completion date: December 2029

Study information

• Verified date: June 2024
• Source: Ivoclar Vivadent AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 22
• Est. completion date: December 2029
• Est. primary completion date: December 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 84 Years

Eligibility

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

Related Conditions & MeSH terms

• Edentulous Mouth
• Mouth, Edentulous

Intervention

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

Locations

Country	Name	City	State
Liechtenstein	Ivoclar Vivadent AG	Schaan

Sponsors (1)

Lead Sponsor	Collaborator
Ivoclar Vivadent AG

Country where clinical trial is conducted

Liechtenstein, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of failures leading to replacement of denture	number of dentures	5 years
Secondary	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
Secondary	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
Secondary	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