Evaluation of the Solvent Evaporation Time of Universal Adhesives in the Quality of Cervical Lesions Restorations
- Conditions
- Non-carious Cervical Lesions
- Interventions
- Procedure: Evaporation time for 25 secondsProcedure: Evaporation time for 5 secondsDevice: acetone-based universal adhesiveDevice: alcohol/water-based universal adhesive
- Registration Number
- NCT05945173
- Lead Sponsor
- Universidad de los Andes, Chile
- Brief Summary
The aim of this study will be to evaluate the effect of prolonging solvent evaporation time on the 6- and 12-months clinical performance of two universal adhesive systems used as selective enamel etch (SEE).
Methods: 140 restorations will be randomly placed in 35 subjects according to the following groups: SUP5 (Scotchbond Universal Plus evaporated for 5 s); SUP25 (Scotchbond Universal Plus evaporated for 25 s); GBU5 (Gluma Bond Universal evaporated for 5 s); GBU25 (Gluma Bond Universal evaporated for 25 s). Resin composite will be placed incrementally and light-cured. The restorations will be evaluated at baseline, after a week, 6 and 12 months using the FDI and USPHS criteria. Statistical analyses will be performed using appropriate tests (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 alcohol- and water-based solvent universal adhesive (Scotchbond Universal Plus; 3M) in the selective enamel etching strategy with evaporation of solvent for 25 seconds. Experimental group 2: 35 non-carious cervical lesions (NCCL) will receive composite resin restorations using an acetone-based universal solvent adhesive (Gluma Universal Bond; Kulzer) in the selective enamel etching strategy with solvent evaporation for 25 seconds. Control group 1: 35 non-carious cervical lesions (NCCL) will receive composite resin restorations, using an alcohol- and water-based universal solvent adhesive (Scotchbond Universal Plus; 3M), in the selective enamel etching strategy, with evaporation of solvent for 5 seconds. Control group 2: 35 non-carious cervical lesions (NCCL) will receive composite resin restorations, using an acetone-based universal solvent adhesive (Gluma Universal Bond; Kulzer), in the strategy of selective enamel etching, with solvent evaporation for 5 seconds. LCNCs will be randomized to universal adhesive usage and flash-off time. All groups will be light-cured with a light-curing device (SmartLite Focus, Dentsply) with a light intensity of 855 mW/cm² for 20 seconds. Operators will restore the cervical area by applying three increments of resin (Opallis, FGM Prod. Odont.Ltda, Joinville, SC, Brazil). Each increment will light cure for 10 s at 1200 mW/cm2 (Radii Cal, SDI, Victoria, Australia). Restorations will be finished immediately with fine diamond burs (#3195F and #3195FF, KG Sorensen, Barueri, SP, Brazil) and polished with discs and polishing gums (Soflex, 3 M ESPE, St. Paul, MN, EE. UU.).
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 Evaporation time for 25 seconds 35 non-carious cervical lesions (NCCL) will receive composite resin restorations in the selective enamel etching strategy. Experimental group 2 acetone-based universal adhesive 35 non-carious cervical lesions (NCCL) will receive composite resin restorations in the selective enamel etching strategy. Experimental group 1 Evaporation time for 25 seconds 35 non-carious cervical lesions (NCCL) will receive composite resin restorations in the selective enamel etching strategy. Experimental group 1 alcohol/water-based universal adhesive 35 non-carious cervical lesions (NCCL) will receive composite resin restorations in the selective enamel etching strategy. Control group 1 Evaporation time for 5 seconds 35 non-carious cervical lesions (NCCL) will receive composite resin restorations in the selective enamel etching strategy. Control group 2 acetone-based universal adhesive 35 non-carious cervical lesions (NCCL) will receive composite resin restorations in the selective enamel etching strategy. Control group 1 alcohol/water-based universal adhesive 35 non-carious cervical lesions (NCCL) will receive composite resin restorations in the selective enamel etching strategy. Control group 2 Evaporation time for 5 seconds 35 non-carious cervical lesions (NCCL) will receive composite resin restorations in the selective enamel etching 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 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.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 intervention
Trial Locations
- Locations (1)
Mario Felipe Gutiérrez Reyes
🇨🇱Santiago, Región Metropolitana, Chile