Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2026-01-03 @ 10:44 AM
Study NCT ID:
NCT03036566
Status:
TERMINATED
Last Update Posted:
2024-07-25
First Post:
2017-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Lithium Disilicate (CAD/CAM) Fixed Partial Dentures (FPD) Clinical Study
Sponsor:
University of Michigan
Organization:
Study Overview
Official Title:
Clinical Evaluation of Chairside Computer Assisted Design/Computer Assisted Machining (CAD/CAM) Lithium Disilicate Fixed Partial Dentures (FPD)
Status:
TERMINATED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Loss of funding due to COVID-19
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This investigation will be a clinical trial to study the performance of a high strength ceramic material for bridges to replace missing teeth. The ceramic material has been approved by the FDA for patient treatment. A computer technique will be used to make the bridges. The bridges will be cemented using an adhesive resin cement (MultiLink Automix/Ivoclar). The bridges are planned be evaluated for clinical performance at 6 months, 1 year, 2 years, 3 years, and if funding permits, 4 years, and 5 years. The purpose of the study is to measure how well the high strength bridges function over an extended period of time.
Detailed Description:
The study will be composed of 30 bridges placed in adult patients that have been identified as requiring replacement of a single tooth. All the bridges will be made from the same high strength ceramic material (emaxCAD/Ivoclar) using a computer to make the entire bridge. All the crowns will be cemented using the most current marketed version of the manufacturer's adhesive resin cement (MultiLink Automix/Ivoclar). At each recall appointment an evaluation of the bridge will be completed as well as clinical photographs, an intraoral digital scan, and impression of the bridge. The purpose of the study is to measure how well the high strength bridges function over an extended period of time.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: