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Active, Not Recruiting

NCT Number: NCT06458738

Clinical Evaluation of a New Printable Denture Base Material

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Edentulous Mouth Mouth Diseases Mouth, Edentulous Stomatognathic Diseases Tooth Diseases

Age range

18 year–84 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ivoclar Vivadent AG

Schaan, Liechtenstein, 9494

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Printable denture base material

Device

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

Primary outcomes

  1. rate of failures leading to replacement of denture

    Time frame: 5 years

    number of dentures

Secondary outcomes

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

    Time frame: 5 years

    Evaluated according to adapted FDI criteria (grade 1-4). Lower scores mean a better outcome.

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

    Time frame: 5 years

    Evaluated according to adapted FDI criteria (grade 1-4). Lower scores mean a better outcome.

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

    Time frame: 5 years

    Evaluated according to adapted FDI criteria (grade 1-4). Lower scores mean a better outcome.

Sponsors and collaborators

Lead sponsor

Ivoclar Vivadent AG

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Jun 14, 2024
Registry last updated
Sep 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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