Ignite Creation Date:
2024-05-06 @ 9:29 AM
Last Modification Date:
2024-10-26 @ 12:15 PM
Study NCT ID:
NCT02991573
Status:
COMPLETED
Last Update Posted:
2023-11-15
First Post:
2015-12-04
Brief Title:
Clinical Study Class II on Ceramx Universal and PrimeBond
Sponsor:
Sheffield Teaching Hospitals NHS Foundation Trust
Organization:
Sheffield Teaching Hospitals NHS Foundation Trust
Study Overview
Official Title:
Clinical Post-Market Surveillance Study of Ceramx Universal and PrimeBond Universal When Used for Class II Restorations at the University of Sheffield
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Damage to teeth from decay or previous old silver fillings can be repaired with tooth-coloured filling materials that stick to the tooth These materials have been around for some years and have become more sophisticated with greater ease of placement by the dentist and better durability for the patient The fillings are designed to be used in combination with a specific glue adhesive that is designed to stick to the different parts of the tooth to provide a good seal the outer enamel and the inner dentine
This study will examine the performance of a state-of-the-art modern tooth coloured filling material Ceram X in combination with an existing adhesive control adhesive and a new adhesive Prime Bond Universal used in two different techniques both of which are known to work but one is easier to apply This results in three treatment groups
At the start of the study the test material PrimeBond Universal is CE-marked as are all other medical devices used Thus this study is not conducted to meet any regulatory requirements The rationale of this study is the extension of knowledge primarily concerning the clinical performance of PrimeBond Universal in molars
Two investigators to be confirmed will place a minimum of 25 restorations per group 75 restorations in total to assess the performance of the materials in a comparative design The study restorations will be monitored for a period of 18 months with the option to extend the evaluation period to 48 months
After placement of restorations under controlled clinical conditions the primary objective of the study is the determination of post-operative sensitivity and pulp vitality marginal adaptation and staining of margins of the restorations In addition fracture of material and retention recurrent caries occlusal contour and wear approximal anatomical form will be determined as well as the failure rate as defined by the ADA
This study will examine the performance of a state-of-the-art modern tooth coloured filling material Ceram X in combination with an existing adhesive control adhesive and a new adhesive Prime Bond Universal used in two different techniques both of which are known to work but one is easier to apply This results in three treatment groups
At the start of the study the test material PrimeBond Universal is CE-marked as are all other medical devices used Thus this study is not conducted to meet any regulatory requirements The rationale of this study is the extension of knowledge primarily concerning the clinical performance of PrimeBond Universal in molars
Two investigators to be confirmed will place a minimum of 25 restorations per group 75 restorations in total to assess the performance of the materials in a comparative design The study restorations will be monitored for a period of 18 months with the option to extend the evaluation period to 48 months
After placement of restorations under controlled clinical conditions the primary objective of the study is the determination of post-operative sensitivity and pulp vitality marginal adaptation and staining of margins of the restorations In addition fracture of material and retention recurrent caries occlusal contour and wear approximal anatomical form will be determined as well as the failure rate as defined by the ADA
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None