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NCT05599269 Clinical Trial

Retrospective Clinical Evaluation of Nano-hybrid-composite Denture Teeth

Edentulous Mouth Clinical Trial

Official title:
Retrospective Clinical Evaluation of Nano-hybrid-composite Denture Teeth SR Phonares II

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05599269
Other study ID # LL5267725
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date October 1, 2022
Est. completion date March 2023

Study information
Verified date October 2022
Source Ivoclar Vivadent AG
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This retrospective study investigates the longevity of dentures with SR Phonares II teeth after a wearing period of more than 10 years. The primary objective is to assess the survival rate of dentures with SR Phonares II teeth after more than 10 years. The secondary objectives asses the quality of the dentures concerning aesthetic, functional and biological properties.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 22
Est. completion date March 2023
Est. primary completion date March 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - informed consent signed and understood by the subject - partial or full denture with SR Phonares II teeth - dentures delivered in the internal clinic between August 2010 and August 2012 - to be able to visit the internal clinic (Exception: Patients with limited mobility are also included if another person can carry the dentures to the internal clinic of Ivoclar Vivadent AG for the examination.) Exclusion Criteria: - patient does not wear the dentures regularly - health status (physical and mental) does not allow participation.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Examination of dentures with SR Phonares II teeth
The intraoral situation will be examined similar to a standard dental examination. The dentures are then removed, cleaned and examined extraoral. Pictures and an impression of the dentures are taken.

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 Survival rate of dentures with SR Phonares II teeth Examination by dentist 6 months
Secondary Quality of the dentures concerning aesthetic, functional and biological properties Parameters are evaluated according to adopted FDI criteria by the dentist 6 months
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