Evaluation of the Reduced Dentin Etching Time Using Universal Adhesives in the Quality of Cervical Lesions Restorations
NCT Number: NCT06465849
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Non-carious Cervical Lesions
Interventions: PROCEDURE: Dentin Etching time for 5 seconds|DEVICE: Scotchbond Universal Plus; 3M|DEVICE: Gluma Universal Bond; Kulzer|PROCEDURE: Dentin Etching time for 15 seconds
Sponsor: Universidad de los Andes, Chile
Collaborators: Agencia Nacional de Investigación y Desarrollo
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 35
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-03-30
Completion Date: 2024-04-23
Locations: Mario Felipe Gutiérrez Reyes, Santiago, Región Metropolitana, 8360053, Chile

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).

Primary Outcome Measures: Retention of restorations, Retention measured by World Dental Federation (FDI) criteria as following:

* VG: Clinically very good - Restoration retained, no fractures / cracks;
* G: Clinically good - Small hairline crack;
* SS: Clinically sufficient/satisfactory - Two or more or larger hairline cracks and/or chipping (not affecting the marginal integrity);
* US: Clinically unsatisfactory - Chipping fractures which damage marginal quality; bulk fractures with or without partial loss (less than half of the restoration);
* PO: Clinically poor - (Partial or complete) loss of restoration, (replacement necessary)., From date of randomization until twenty four months
Secondary Outcome Measures: Marginal Adaptation of restorations, Marginal Adaptation measured by World Dental Federation (FDI) criteria as following:

* VG: Clinically very good - Harmonious outline, no gaps, no discoloration;
* G: Clinically good - Small marginal fracture removable by polishing;
* SS: Clinically sufficient/satisfactory - Several small enamel or dentin fractures;
* US: Clinically unsatisfactory - Notable enamel or dentine wall fracture;
* PO: Clinically poor - Filling is loose but in situ., From date of randomization until twenty four months|Marginal Staining of restorations, Marginal Staining measured by World Dental Federation (FDI) criteria as following:

* VG: Clinically very good - No marginal staining;
* G: Clinically good - Minor marginal staining, easily removable by polishing;
* SS: Clinically sufficient/satisfactory - Moderate marginal staining, not esthetically unacceptable;
* US: Clinically unsatisfactory - Pronounced marginal staining; major intervention necessary for improvement;
* PO: Clinically poor - Deep marginal staining not accessible for intervention, From date of randomization until twenty four months