NCT06465849

Evaluation of the Reduced Dentin Etching Time Using Universal Adhesives in the Quality of Cervical Lesions Restorations

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Universidad de los Andes, Chile · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Accepted

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 10s/1,000 mW/cm2. A resin composite will be placed by applying three increments and each one will be light cured for 20s/1,000 mW/cm2. 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 = 0.05).

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 mW/cm² for 10 seconds. Operators will restore the cervical area by applying three increments of resin (Vittra APS, FGM Prod. Odont.Ltda, Joinville, SC, Brazil). Each increment will light cure for 20 s at 900 mW/cm2 (SmartLite Focus, Dentsply). Restorations will be finished immediately with fine and extra fine diamond burs and polished with polishing gums.

Conditions

• Non-carious Cervical Lesions

Interventions

Type	Name	Description
PROCEDURE	Dentin Etching time for 5 seconds	Composite resin restorations of non-carious cervical lesions will be performed with an adhesive on dentin etched for 5 seconds in the etch-and-rinse application strategy.
DEVICE	Scotchbond Universal Plus; 3M	Composite resin restorations of non-carious cervical lesions will be performed with an universal adhesive (Scotchbond Universal Plus; 3M).
DEVICE	Gluma Universal Bond; Kulzer	Composite resin restorations of non-carious cervical lesions will be performed with an universal adhesive (Gluma Universal Bond; Kulzer).
PROCEDURE	Dentin Etching time for 15 seconds	Composite resin restorations of non-carious cervical lesions will be performed with an adhesive on dentin etched for 15 seconds in the etch-and-rinse application strategy.

Timeline

• Start date: 2024-03-30
• Primary completion: 2024-04-23
• Completion: 2024-04-23
• First posted: 2024-06-20
• Last updated: 2024-06-20

Locations

1 site across 1 country: Chile