Back to resultsRetrospective Clinical Evaluation of Nano-hybrid-composite Denture Teeth
Primary Purpose
Edentulous Mouth, Dental Prosthesis Failure
Status
Active
Phase
Not Applicable
Locations
Liechtenstein
Study Type
Interventional
Intervention
Examination of dentures with SR Phonares II teeth
Sponsored by
About this trial
This is an interventional treatment trial for Edentulous Mouth
Eligibility Criteria
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.
Sites / Locations
- Ivoclar Vivadent AG
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Examination of dentures with SR Phonares II teeth
Arm Description
Outcomes
Primary Outcome Measures
Survival rate of dentures with SR Phonares II teeth
Examination by dentist
Secondary Outcome Measures
Quality of the dentures concerning aesthetic, functional and biological properties
Parameters are evaluated according to adopted FDI criteria by the dentist
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05599269
Brief Title
Retrospective Clinical Evaluation of Nano-hybrid-composite Denture Teeth
Official Title
Retrospective Clinical Evaluation of Nano-hybrid-composite Denture Teeth SR Phonares II
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
March 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ivoclar Vivadent AG
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Edentulous Mouth, Dental Prosthesis Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
retrospective study
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Examination of dentures with SR Phonares II teeth
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Examination of dentures with SR Phonares II teeth
Intervention Description
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.
Primary Outcome Measure Information:
Title
Survival rate of dentures with SR Phonares II teeth
Description
Examination by dentist
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Quality of the dentures concerning aesthetic, functional and biological properties
Description
Parameters are evaluated according to adopted FDI criteria by the dentist
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Ivoclar Vivadent AG
City
Schaan
ZIP/Postal Code
9494
Country
Liechtenstein
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Retrospective Clinical Evaluation of Nano-hybrid-composite Denture Teeth
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