Evaluation of the Reduced Dentin Etching Time Using Universal Adhesives in the Quality of Cervical Lesions Restorations
- Conditions
- Non-carious Cervical Lesions
- Interventions
- Procedure: Dentin Etching time for 5 secondsDevice: Gluma Universal Bond; KulzerProcedure: Dentin Etching time for 15 secondsDevice: Scotchbond Universal Plus; 3M
- Registration Number
- NCT06465849
- Lead Sponsor
- Universidad de los Andes, Chile
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
- 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.
- Non-Carious Cervical Lesions with a maximum of 50% of enamel margin.
- 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
- Arm && Interventions
Group Intervention Description Experimental group 2 Gluma Universal Bond; Kulzer 35 non-carious cervical lesions (NCCL) will receive composite resin restorations in the etch-and-rinse strategy. Control group 2 Dentin Etching time for 15 seconds 35 non-carious cervical lesions (NCCL) will receive composite resin restorations in the etch-and-rinse strategy. Experimental group 2 Dentin Etching time for 5 seconds 35 non-carious cervical lesions (NCCL) will receive composite resin restorations in the etch-and-rinse strategy. Experimental group 1 Dentin Etching time for 5 seconds 35 non-carious cervical lesions (NCCL) will receive composite resin restorations in the etch-and-rinse strategy. Experimental group 1 Scotchbond Universal Plus; 3M 35 non-carious cervical lesions (NCCL) will receive composite resin restorations in the etch-and-rinse strategy. Control group 1 Dentin Etching time for 15 seconds 35 non-carious cervical lesions (NCCL) will receive composite resin restorations in the etch-and-rinse strategy. Control group 1 Scotchbond Universal Plus; 3M 35 non-carious cervical lesions (NCCL) will receive composite resin restorations in the etch-and-rinse strategy. Control group 2 Gluma Universal Bond; Kulzer 35 non-carious cervical lesions (NCCL) will receive composite resin restorations in the etch-and-rinse strategy.
- Primary Outcome Measures
Name Time Method Retention of restorations From date of randomization until twenty 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 Staining of restorations From date of randomization until twenty four 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 interventionMarginal Adaptation of restorations From date of randomization until twenty four 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.
Trial Locations
- Locations (1)
Mario Felipe Gutiérrez Reyes
🇨🇱Santiago, Región Metropolitana, Chile