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| Name | Class |
|---|---|
| Agencia Nacional de Investigación y Desarrollo | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group 1 | Experimental | 35 non-carious cervical lesions (NCCL) will receive composite resin restorations in the etch-and-rinse strategy. |
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| Experimental group 2 | Experimental | 35 non-carious cervical lesions (NCCL) will receive composite resin restorations in the etch-and-rinse strategy. |
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| Control group 1 | Active Comparator | 35 non-carious cervical lesions (NCCL) will receive composite resin restorations in the etch-and-rinse strategy. |
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| Control group 2 | Active Comparator | 35 non-carious cervical lesions (NCCL) will receive composite resin restorations in the etch-and-rinse strategy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dentin Etching time for 5 seconds | Procedure | Composite resin restorations of non-carious cervical lesions will be performed with an adhesive on dentin etched for 5 seconds in the etch-and-rinse application strategy. |
| Measure | Description | Time Frame |
|---|---|---|
| Retention of restorations | Retention measured by World Dental Federation (FDI) criteria as following:
| From date of randomization until twenty four months |
| Measure | Description | Time Frame |
|---|---|---|
| Marginal Adaptation of restorations | Marginal Adaptation measured by World Dental Federation (FDI) criteria as following:
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mario Felipe Gutiérrez Reyes, PhD | Universidad de los Andes, Chile | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mario Felipe Gutiérrez Reyes | Santiago | Santiago Metropolitan | 8360053 | Chile |
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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 (3M) on dentin etched for 5 seconds.
Experimental group 2: 35 non-carious cervical lesions (NCCL) will receive composite resin restorations using an universal adhesive (Kulzer) on dentin etched for 5 seconds.
Control group 1: 35 non-carious cervical lesions (NCCL) will receive composite resin restorations using an universal adhesive (3M) on dentin etched for 15 seconds.
Control group 2: 35 non-carious cervical lesions (NCCL) will receive composite resin restorations using an universal adhesive (Kulzer) on dentin etched for 15 seconds.
LCNCs will be randomized to universal adhesive usage and etching time.
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Two blinded, experienced, and calibrated dentists (who specialized in esthetic dentistry with more than 15 years of clinical practice), will perform the clinical evaluation. Patients will be also blinded to group assignment. An inter-examiner and inter-examiner agreement of at least 85% will be necessary before beginning the evaluation
| Scotchbond Universal Plus; 3M | Device | Composite resin restorations of non-carious cervical lesions will be performed with an universal adhesive (Scotchbond Universal Plus; 3M). |
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| Gluma Universal Bond; Kulzer | Device | Composite resin restorations of non-carious cervical lesions will be performed with an universal adhesive (Gluma Universal Bond; Kulzer). |
|
| Dentin Etching time for 15 seconds | Procedure | Composite resin restorations of non-carious cervical lesions will be performed with an adhesive on dentin etched for 15 seconds in the etch-and-rinse application strategy. |
|
| From date of randomization until twenty four months |
| Marginal Staining of restorations | Marginal Staining measured by World Dental Federation (FDI) criteria as following:
| From date of randomization until twenty four months |
| ID | Term |
|---|---|
| D014077 | Tooth Erosion |
| D057085 | Tooth Wear |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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