Clinical Evaluation of a New Printable Denture Base Material

NCT ID: NCT06458738

Last Updated: 2024-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-29

Study Completion Date

2029-12-31

Brief Summary

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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

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Conditions

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Edentulous Mouth

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Printable denture base material

Group Type EXPERIMENTAL

Printable denture base material

Intervention Type DEVICE

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

Interventions

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Printable denture base material

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

84 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ivoclar Vivadent AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ivoclar Vivadent AG

Schaan, Liechtenstein, Liechtenstein

Site Status

Countries

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Liechtenstein

Other Identifiers

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OTCS 11891315

Identifier Type: -

Identifier Source: org_study_id

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