Clinical Evaluation of a New Printable Denture Base Material | NCT06458738

Studies
Clinical Evaluation of a New Printable Denture Base Material

NCT06458738

Sponsor

Ivoclar Vivadent AG

Status

Active, not recruiting

Last Update Posted

Sep 26, 2024Actual

Enrollment

22Estimated

Phase

Not Applicable

Conditions

Edentulous Mouth

Interventions

Printable denture base material

Countries

Liechtenstein

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2024

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 29, 2024Actual

Primary Completion Date

Dec 2029Estimated

Completion Date

Dec 2029Estimated

First Submitted Date

Jun 6, 2024

First Submission Date that Met QC Criteria

Jun 12, 2024

First Posted Date

Jun 14, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 24, 2024

Last Update Posted Date

Sep 26, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

22Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Printable denture base material	Experimental		Device: Printable denture base material

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Printable denture base material	Device	The newly developed printable denture base material will be used for the production of dentures.	Printable denture base material

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
rate of failures leading to replacement of denture	number of dentures	5 years

Secondary Outcomes

Measure	Description	Time Frame
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
biological (e.g. plaque accumulation) properties of the dentures

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

84 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ivoclar Vivadent AG		Schaan	Liechtenstein	9494	Liechtenstein

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009066	Mouth, Edentulous

Ancestor Terms

ID	Term
D009059	Mouth Diseases
D009057	Stomatognathic Diseases
D014076	Tooth Diseases

Browse Leaves

Not provided

Browse Branches

Not provided