Ignite Creation Date:
2024-07-17 @ 11:00 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06465849
Status:
COMPLETED
Last Update Posted:
2024-06-20
First Post:
2024-06-13
Brief Title:
Evaluation of the Reduced Dentin Etching Time Using Universal Adhesives in the Quality of Cervical Lesions Restorations
Sponsor:
Universidad de los Andes Chile
Organization:
Universidad de los Andes Chile
Study Overview
Official Title:
Clinical Evaluation of the Effect of Reduced Dentin Etching Time Using Two Universal Adhesives in Restorations of Non-carious Cervical Lesions Double-blind Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2024-06
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:
The aim of this study will be to evaluate the effect of reduced dentin etching time on the 6- and 12-months clinical performance of two universal adhesive systems used as etch-and-rinse application mode in non-carious cervical lesions NCCLs
Materials Methods 140 restorations will be randomly placed in 35 subjects according to the following groups SUP5 Scotchbond Universal Plus adhesive on dentin etched for 5 seconds SUP15 Scotchbond Universal Plus adhesive on dentin etched for 15 seconds GBU5 Gluma Universal Bond adhesive on dentin etched for 5 seconds GBU15 Gluma Universal Bond adhesive on dentin etched for 15 seconds All groups will be light-cured for 10s1000 mWcm2 A resin composite will be placed by applying three increments and each one will be light cured for 20s1000 mWcm2 The restorations will be finished immediately with fine diamond burs and polishers The restorations will be evaluated at baseline and after 6- and 12-months by using the FDI criteria The following outcomes will be evaluated retention marginal staining marginal adaptation post-operative sensitivity and recurrence of caries The differences among the groups will be calculated using Friedman repeated measures analysis of variance rank α 005
Materials Methods 140 restorations will be randomly placed in 35 subjects according to the following groups SUP5 Scotchbond Universal Plus adhesive on dentin etched for 5 seconds SUP15 Scotchbond Universal Plus adhesive on dentin etched for 15 seconds GBU5 Gluma Universal Bond adhesive on dentin etched for 5 seconds GBU15 Gluma Universal Bond adhesive on dentin etched for 15 seconds All groups will be light-cured for 10s1000 mWcm2 A resin composite will be placed by applying three increments and each one will be light cured for 20s1000 mWcm2 The restorations will be finished immediately with fine diamond burs and polishers The restorations will be evaluated at baseline and after 6- and 12-months by using the FDI criteria The following outcomes will be evaluated retention marginal staining marginal adaptation post-operative sensitivity and recurrence of caries The differences among the groups will be calculated using Friedman repeated measures analysis of variance rank α 005
Detailed Description:
This is a four-arm double-blind randomized controlled clinical trial Experimental group 1 35 non-carious cervical lesions NCCL will receive composite resin restorations using an universal adhesive Scotchbond Universal Plus 3M on dentin etched for 5 seconds in the etch-and-rinse application strategy
Experimental group 2 35 non-carious cervical lesions NCCL will receive composite resin restorations using an universal adhesive Gluma Universal Bond Kulzer on dentin etched for 5 seconds in the etch-and-rinse application strategy
Control group 1 35 non-carious cervical lesions NCCL will receive composite resin restorations using an universal adhesive Scotchbond Universal Plus 3M on dentin etched for 15 seconds in the etch-and-rinse application strategy
Control group 2 35 non-carious cervical lesions NCCL will receive composite resin restorations using an universal adhesive Gluma Universal Bond Kulzer on dentin etched for 15 seconds in the etch-and-rinse application strategy
LCNCs will be randomized to universal adhesive usage and dentin etching time All groups will be light-cured with a lightcuring device SmartLite Focus Dentsply with a light intensity of 900 mWcm² for 10 seconds Operators will restore the cervical area by applying three increments of resin Vittra APS FGM Prod OdontLtda Joinville SC Brazil Each increment will light cure for 20 s at 900 mWcm2 SmartLite Focus Dentsply Restorations will be finished immediately with fine and extra fine diamond burs and polished with polishing gums
Experimental group 2 35 non-carious cervical lesions NCCL will receive composite resin restorations using an universal adhesive Gluma Universal Bond Kulzer on dentin etched for 5 seconds in the etch-and-rinse application strategy
Control group 1 35 non-carious cervical lesions NCCL will receive composite resin restorations using an universal adhesive Scotchbond Universal Plus 3M on dentin etched for 15 seconds in the etch-and-rinse application strategy
Control group 2 35 non-carious cervical lesions NCCL will receive composite resin restorations using an universal adhesive Gluma Universal Bond Kulzer on dentin etched for 15 seconds in the etch-and-rinse application strategy
LCNCs will be randomized to universal adhesive usage and dentin etching time All groups will be light-cured with a lightcuring device SmartLite Focus Dentsply with a light intensity of 900 mWcm² for 10 seconds Operators will restore the cervical area by applying three increments of resin Vittra APS FGM Prod OdontLtda Joinville SC Brazil Each increment will light cure for 20 s at 900 mWcm2 SmartLite Focus Dentsply Restorations will be finished immediately with fine and extra fine diamond burs and polished with polishing gums
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None