Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06532916
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-29
Brief Title:
Color Stability and Wear Resistance of Direct Flowable and Preheated Composite Using the Injectable Technique
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Color Stability and Wear Resistance of Direct Flowable and Preheated Resin Composite Veneers Using the Injectable Resin Technique A Randomized Controlled Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to conduct the first clinical trial to assess the color stability and wear resistance of the highly filled injectable flowable composite materials compared to preheated conventional ones and evaluate the in vivo performance of the injectable composite technique
Detailed Description:
The design of study will be a modified split-mouth randomized clinical trial with two study groups 20 patients will be recruited with the need of at least 6 anterior aesthetic restorations A total of 142 restorations will be assigned into two groups In the first group 71 anterior teeth will be restored with flowable composite veneer restorations and the second group 71 anterior teeth will be restored with heated composite veneer restorations Both treatment groups will be done using the injectable resin technique The following parameters will be evaluated at baseline 6 months and 12 months of clinical service Color stability will be evaluated using the Vita classical shade guide and a spectrophotometer Wear resistance will be evaluated by measuring the volumetric material loss through superimposition of images taken at each follow up on baseline images taken by scanning of gypsum replicas using a 3D laser scanner Clinical performance will be evaluated using the USPHS criteria It is expected that the color stability wear resistance and clinical performance of the heated composite restorations will be superior to the flowable restorations
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