Evaluation of Double Layer Application Using a Universal Adhesive in the Quality of Cervical Lesions Restorations
NCT Number: NCT06474494
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Non-carious Cervical Lesions
Interventions: PROCEDURE: Application of one layer|PROCEDURE: Application of double layer|PROCEDURE: Etch-and-rinse application mode|PROCEDURE: Selective enamel etching application mode
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: 2024-03-01
Completion Date: 2024-03-01
Locations: Mario Felipe Gutiérrez Reyes, Santiago, Región Metropolitana, 8360053, Chile

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 (n=36): 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 10s/1,000 mW/cm2 only after final layer. 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 rate of restorations, Retention rate measured by World Dental Federation (FDI) criteria as following:

* 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 rate of restorations, Marginal Adaptation rate 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 rate of restorations, Marginal Staining rate 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]