An interventional study of Application of one layer and Application of double layer in Non-carious Cervical Lesions, sponsored by Universidad de los Andes, Chile. Completed at 1 site in Chile. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-26.
Sponsored by Universidad de los Andes, Chile · Not applicable, Interventional, and Treatment
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).
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 applying a double layer of Scotchbond Universal Plus adhesive applied as etch-and-rinse mode.
Experimental group 2: 35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying a double layer of Scotchbond Universal Plus adhesive applied as selective enamel etching mode.
Control group 1: 35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying one layer of Scotchbond Universal Plus adhesive applied as etch-and-rinse mode.
Control group 2: 35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying one layer of Scotchbond Universal Plus adhesive applied as selective enamel etching mode.
LCNCs will be randomized to application mode and number of layers. All groups will be light-cured with a light-curing 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 (Filtek Supreme XT, 3M). 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 spirals.
53 studies on the registry are indexed under Uterine Cervical Diseases; 11 are open to participants now.
This study's enrollment of 35 is below the median of 48 across 40 interventional studies indexed under Uterine Cervical Diseases.
Browse Uterine Cervical Diseases studies →Universidad de los Andes, Chile is the lead sponsor of 44 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying double layer of Scotchbond Universal Plus adhesive applied as etch-and-rinse mode
Procedure: Application of double layer · Procedure: Etch-and-rinse application mode
35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying double layer of Scotchbond Universal Plus adhesive applied as selective enamel etching mode
Procedure: Application of double layer · Procedure: Selective enamel etching application mode
35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying one layer of Scotchbond Universal Plus adhesive applied as etch-and-rinse mode
Procedure: Application of one layer · Procedure: Etch-and-rinse application mode
35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying one layer of Scotchbond Universal Plus adhesive applied as selective enamel etching mode
Procedure: Application of one layer · Procedure: Selective enamel etching application mode
35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying one layer of Scotchbond Universal Plus adhesive
35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying double layer of Scotchbond Universal Plus adhesive
35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying Scotchbond Universal Plus adhesive applied as etch-and-rinse application mode
35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying Scotchbond Universal Plus adhesive applied as selective enamel etching mode
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).
Time frame: From date of randomization until twenty four months
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.
Time frame: 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
Time frame: From date of randomization until twenty four months]
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Universidad de los Andes, Chile