Evaluation of Double Layer Application Using a Universal Adhesive in the Quality of Cervical Lesions Restorations
NCT06474494 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35
Last updated 2024-06-26
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).
Conditions
- Non-carious Cervical Lesions
Interventions
- PROCEDURE
-
Application of one layer
35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying one layer of Scotchbond Universal Plus adhesive
- PROCEDURE
-
Application of double layer
35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying double layer of Scotchbond Universal Plus adhesive
- PROCEDURE
-
Etch-and-rinse application mode
35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying Scotchbond Universal Plus adhesive applied as etch-and-rinse application mode
- PROCEDURE
-
Selective enamel etching application mode
35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying Scotchbond Universal Plus adhesive applied as selective enamel etching mode
Sponsors & Collaborators
-
Agencia Nacional de Investigación y Desarrollo
collaborator OTHER -
Universidad de los Andes, Chile
lead OTHER
Principal Investigators
-
Mario Felipe Gutierrez Reyes · Universidad de los Andes, Chile
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 99 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-03-01
- Primary Completion
- 2024-03-01
- Completion
- 2024-03-01
Countries
- Chile
Study Locations
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