Effect of Wet and Overwet Dentin on the Clinical Performance of Two Universal Adhesive Systems
- Conditions
- Non-carious Cervical Lesions
- Registration Number
- NCT07034235
- Lead Sponsor
- Universidad de los Andes, Chile
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- Patients older than 18 years.
- Presence of at least two Non-Carious Cervical Lesions in the dental arch with a need for restorative treatment.
- Acceptable level of oral hygiene according to the Simplified Oral Hygiene Index.
- At least 20 teeth in function.
- Driving difficulties that prevent adequate oral hygiene.
- Periodontal disease.
- Active caries lesions on the teeth included in the research.
- Parafunctional habits.
- Active staples of removable partial dentures on the teeth included in the research and that these are not pillars of prostheses.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Retention of restorations From date of randomization until thirty-six four months 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).
- Secondary Outcome Measures
Name Time Method Marginal Adaptation of restorations From date of randomization until thirty six months 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.Marginal Staining of restorations From date of randomization until thirty six months 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
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Trial Locations
- Locations (1)
Mario Felipe Gutiérrez Reyes
🇨🇱Santiago, Región Metropolitana, Chile
Mario Felipe Gutiérrez Reyes🇨🇱Santiago, Región Metropolitana, Chile