An interventional study of Dentin Wet and Dentin Overwet 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 2025-06-24.
Sponsored by Universidad de los Andes, Chile · Not applicable, Interventional, and Treatment
The aim of this study will be to evaluate the effect of wet and overwet dentin on the long-term clinical performance of two universal adhesive systems used as etch-and-rinse application mode in non-carious cervical lesions (NCCLs).
Materials \& Methods: 200 restorations will be randomly placed in 50 subjects according to the following groups (n=50): AMP-wet (Ambar Universal APS Plus adhesive on wet dentin); AMP-overwet (Ambar Universal APS Plus adhesive on oversaturated dentin); PBA-wet (Prime\&Bond Active adhesive on wet dentin); PBA-overwet (Prime\&Bond Active adhesive on oversaturated dentin). For all groups, the enamel and dentin will be etched for 15s. 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 was light cured for 20s/1,000 mW/cm2. The restorations will be finished immediately with fine diamond burs and spiral polishers. The restorations will be evaluated at baseline and after 6 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.
Control group 1: 50 non-carious cervical lesions (NCCL) will receive composite resin restorations using an universal adhesive (Ambar Universal APS Plus; FGM) on wet dentin in the etch-and-rinse application strategy.
Control group 2: 50 non-carious cervical lesions (NCCL) will receive composite resin restorations using an universal adhesive (Prime\&Bond Active; Dentsply Sirona) on wet dentin in the etch-and-rinse application strategy.
Experimental group 1: 50 non-carious cervical lesions (NCCL) will receive composite resin restorations using an universal adhesive (Ambar Universal APS Plus; FGM) on overwet dentin in the etch-and-rinse application strategy.
Experimental group 2: 50 non-carious cervical lesions (NCCL) will receive composite resin restorations using an universal adhesive (Prime\&Bond Active; Dentsply Sirona) on overwet dentin in the etch-and-rinse application strategy
LCNCs will be randomized to universal adhesive usage and dentinal moisture levels. All groups will be light-cured with a lightcuring device (Quazar, FGM) with a light intensity of 900 mW/cm² for 10 seconds. Operators will restore the cervical area by applying three increments of resin (Llis-FGM for experimental groups 1 and 2; and TPH Spectrum-Dentsply for experimental groups 3 and 4). Each increment will light cure for 20 s at 900 mW/cm2 (Quazar, FGM). Restorations will be finished immediately with fine and extra fine diamond burs and polished with polishing spirals.
47 studies on the registry are indexed under Tooth Erosion; 7 are open to participants now.
This study's enrollment of 50 is above the median of 33 across 33 interventional studies indexed under Tooth Erosion.
Browse Tooth Erosion studies →Universidad de los Andes, Chile is the lead sponsor of 46 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
50 non-carious cervical lesions (NCCL) will receive composite resin restorations in the etch-and-rinse strategy.
Procedure: Dentin Overwet · Device: Ambar Universal APS Plus; FGM
50 non-carious cervical lesions (NCCL) will receive composite resin restorations in the etch-and-rinse strategy.
Procedure: Dentin Overwet · Device: Prime&Bond Active; Dentsply Sirona
50 non-carious cervical lesions (NCCL) will receive composite resin restorations in the etch-and-rinse strategy.
Procedure: Dentin Wet · Device: Ambar Universal APS Plus; FGM
50 non-carious cervical lesions (NCCL) will receive composite resin restorations in the etch-and-rinse strategy.
Procedure: Dentin Wet · Device: Prime&Bond Active; Dentsply Sirona
Composite resin restorations of non-carious cervical lesions will be performed with an adhesive on wet dentin in the etch-and-rinse application strategy.
Composite resin restorations of non-carious cervical lesions will be performed with an adhesive on overwet dentin in the etch-and-rinse application strategy.
Composite resin restorations of non-carious cervical lesions will be performed with an universal adhesive
Composite resin restorations of non-carious cervical lesions will be performed with an universal adhesive
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).
Time frame: From date of randomization until thirty-six four months
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.
Time frame: From date of randomization until thirty six 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
Time frame: From date of randomization until thirty six months
Plan to share: No
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Ran from Jan 2025 to primary completion in Mar 2025, 1 month.
Of 20 interventional studies with no phase under Tooth Erosion, half reached primary completion within 6 months of starting (the median), counting those still running; a quarter within 1 and three quarters within 28. This study's 1 month is below that.
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This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Universidad de los Andes, Chile