Evaluation of the Reduced Dentin Etching Time Using Universal Adhesives in the Quality of Cervical Lesions Restorations

Non-carious Cervical Lesions Clinical Trial

Official title:

Clinical Evaluation of the Effect of Reduced Dentin Etching Time Using Two Universal Adhesives in Restorations of Non-carious Cervical Lesions: Double-blind Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06465849
• Other study ID #: CEC2024055
• Status: Completed
• Phase: N/A
• Start date: March 30, 2024
• Est. completion date: April 23, 2024

Study information

• Verified date: June 2024
• Source: Universidad de los Andes, Chile
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: April 23, 2024
• Est. primary completion date: April 23, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Non-carious Cervical Lesions
• Uterine Cervical Diseases

Intervention

Procedure:
• Dentin Etching time for 5 seconds
Composite resin restorations of non-carious cervical lesions will be performed with an adhesive on dentin etched for 5 seconds in the etch-and-rinse application strategy.

Device:
• Scotchbond Universal Plus; 3M
Composite resin restorations of non-carious cervical lesions will be performed with an universal adhesive (Scotchbond Universal Plus; 3M).
• Gluma Universal Bond; Kulzer
Composite resin restorations of non-carious cervical lesions will be performed with an universal adhesive (Gluma Universal Bond; Kulzer).

Procedure:
• Dentin Etching time for 15 seconds
Composite resin restorations of non-carious cervical lesions will be performed with an adhesive on dentin etched for 15 seconds in the etch-and-rinse application strategy.

Locations

Country	Name	City	State
Chile	Mario Felipe Gutiérrez Reyes	Santiago	Región Metropolitana

Sponsors (2)

Lead Sponsor	Collaborator
Universidad de los Andes, Chile	Agencia Nacional de Investigación y Desarrollo

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	From date of randomization until twenty four months
Secondary	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.	From date of randomization until twenty four months
Secondary	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	From date of randomization until twenty four months