Evaluation of the Solvent Evaporation Time of Universal Adhesives in the Quality of Cervical Lesions Restorations

Non-carious Cervical Lesions Clinical Trial

Official title:

Clinical Evaluation of the Effect of the Prolonged Evaporation Time of the Solvent of Two Universal Adhesives in Restorations of Non-carious Cervical Lesions: Double-blind Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05945173
• Other study ID #: CEC2022129
• Status: Completed
• Phase: N/A
• Start date: March 30, 2023
• Est. completion date: June 23, 2023

Study information

• Verified date: July 2023
• 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 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).

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 information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: June 23, 2023
• Est. primary completion date: June 23, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

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:
• Evaporation time for 5 seconds
Composite resin restorations of non-carious cervical lesions will be performed with an adhesive with solvent evaporation for 5 seconds.
• Evaporation time for 25 seconds
Composite resin restorations of non-carious cervical lesions will be performed with an adhesive with solvent evaporation for 25 seconds.

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

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