Evaluation of Double Layer Application Using a Universal Adhesive in the Quality of Cervical Lesions Restorations
- Conditions
- Non-carious Cervical Lesions
- Interventions
- Procedure: Application of double layerProcedure: Application of one layerProcedure: Etch-and-rinse application modeProcedure: Selective enamel etching application mode
- Registration Number
- NCT06474494
- Lead Sponsor
- Universidad de los Andes, Chile
- Brief Summary
The aim of this study will be to evaluate the effect of a double layer application of a universal adhesive system used as etch-and-rinse application mode in non-carious cervical lesions (NCCLs), on the 6- and 12-months clinical performance.
Materials \& Methods: 144 restorations were randomly placed in 36 subjects (16 male and 20 female) according to the following groups (n=36): ER1 (one layer of Scotchbond Universal Plus adhesive applied as etch-and-rinse mode); ER2 (double layer of Scotchbond Universal Plus adhesive applied as etch-and-rinse mode); SEE1 (one layer of Scotchbond Universal Plus adhesive applied as selective enamel etching); SEE2 (double layer of Scotchbond Universal Plus adhesive applied as selective enamel etching). All groups were light-cured for 10s/1,000 mW/cm2 only after final layer. 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 applying a double layer of Scotchbond Universal Plus adhesive applied as etch-and-rinse mode.
Experimental group 2: 35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying a double layer of Scotchbond Universal Plus adhesive applied as selective enamel etching mode.
Control group 1: 35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying one layer of Scotchbond Universal Plus adhesive applied as etch-and-rinse mode.
Control group 2: 35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying one layer of Scotchbond Universal Plus adhesive applied as selective enamel etching mode.
LCNCs will be randomized to application mode and number of layers. All groups will be light-cured with a light-curing 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 (Filtek Supreme XT, 3M). 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 spirals.
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: Experimental group 1 Etch-and-rinse application mode 35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying double layer of Scotchbond Universal Plus adhesive applied as etch-and-rinse mode Experimental group 2 Application of double layer 35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying double layer of Scotchbond Universal Plus adhesive applied as selective enamel etching mode Experimental group 2 Selective enamel etching application mode 35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying double layer of Scotchbond Universal Plus adhesive applied as selective enamel etching mode Control group 2 Selective enamel etching application mode 35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying one layer of Scotchbond Universal Plus adhesive applied as selective enamel etching mode Control group 1 Etch-and-rinse application mode 35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying one layer of Scotchbond Universal Plus adhesive applied as etch-and-rinse mode Control group 2 Application of one layer 35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying one layer of Scotchbond Universal Plus adhesive applied as selective enamel etching mode Experimental: Experimental group 1 Application of double layer 35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying double layer of Scotchbond Universal Plus adhesive applied as etch-and-rinse mode Control group 1 Application of one layer 35 non-carious cervical lesions (NCCL) will receive composite resin restorations applying one layer of Scotchbond Universal Plus adhesive applied as etch-and-rinse mode
- Primary Outcome Measures
Name Time Method Retention rate of restorations From date of randomization until twenty four months Retention rate measured by World Dental Federation (FDI) criteria as following:
* 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 rate of restorations From date of randomization until twenty four months Marginal Adaptation rate 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 rate of restorations From date of randomization until twenty four months] Marginal Staining rate 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