Ignite Creation Date:
2024-07-17 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06474494
Status:
COMPLETED
Last Update Posted:
2024-06-26
First Post:
2024-06-19
Brief Title:
Evaluation of Double Layer Application Using a Universal Adhesive 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 Double Layer Application Using a Universal Adhesive 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 a double layer application of a universal adhesive system used as etch-and-rinse application mode in non-carious cervical lesions NCCLs on the 6- and 12-months clinical performance
Materials Methods 144 restorations were randomly placed in 36 subjects 16 male and 20 female according to the following groups n36 ER1 one layer of Scotchbond Universal Plus adhesive applied as etch-and-rinse mode ER2 double layer of Scotchbond Universal Plus adhesive applied as etch-and-rinse mode SEE1 one layer of Scotchbond Universal Plus adhesive applied as selective enamel etching SEE2 double layer of Scotchbond Universal Plus adhesive applied as selective enamel etching All groups were light-cured for 10s1000 mWcm2 only after final layer 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 144 restorations were randomly placed in 36 subjects 16 male and 20 female according to the following groups n36 ER1 one layer of Scotchbond Universal Plus adhesive applied as etch-and-rinse mode ER2 double layer of Scotchbond Universal Plus adhesive applied as etch-and-rinse mode SEE1 one layer of Scotchbond Universal Plus adhesive applied as selective enamel etching SEE2 double layer of Scotchbond Universal Plus adhesive applied as selective enamel etching All groups were light-cured for 10s1000 mWcm2 only after final layer 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 applying a double layer of Scotchbond Universal Plus adhesive applied as etch-and-rinse mode
Experimental group 2 35 non-carious cervical lesions NCCL will receive composite resin restorations applying a double layer of Scotchbond Universal Plus adhesive applied as selective enamel etching mode
Control group 1 35 non-carious cervical lesions NCCL will receive composite resin restorations applying one layer of Scotchbond Universal Plus adhesive applied as etch-and-rinse mode
Control group 2 35 non-carious cervical lesions NCCL will receive composite resin restorations applying one layer of Scotchbond Universal Plus adhesive applied as selective enamel etching mode
LCNCs will be randomized to application mode and number of layers All groups will be light-cured with a light-curing 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 Filtek Supreme XT 3M 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 spirals
Experimental group 2 35 non-carious cervical lesions NCCL will receive composite resin restorations applying a double layer of Scotchbond Universal Plus adhesive applied as selective enamel etching mode
Control group 1 35 non-carious cervical lesions NCCL will receive composite resin restorations applying one layer of Scotchbond Universal Plus adhesive applied as etch-and-rinse mode
Control group 2 35 non-carious cervical lesions NCCL will receive composite resin restorations applying one layer of Scotchbond Universal Plus adhesive applied as selective enamel etching mode
LCNCs will be randomized to application mode and number of layers All groups will be light-cured with a light-curing 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 Filtek Supreme XT 3M 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 spirals
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