Evaluation of the Reduced Dentin Etching Time Using Universal Adhesives in

Status Completed

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06465849
Study type	Interventional
Source	Universidad de los Andes, Chile
Contact
Status	Completed
Phase	N/A
Start date	March 30, 2024
Completion date	April 23, 2024

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms