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

Sponsor

Universidad de los Andes, Chile (Other)

Overall Status

Completed

CT.gov ID

NCT05945173

Collaborator

Agencia Nacional de Investigación y Desarrollo (Other)

Enrollment

Location

Arms

2.8

Actual Duration (Months)

12.5

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Non-carious Cervical Lesions	Procedure: Evaporation time for 5 seconds Procedure: Evaporation time for 25 seconds Device: alcohol/water-based universal adhesive Device: acetone-based universal adhesive	N/A

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.).

Study Design

Study Type:

Interventional

Actual Enrollment :

35 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This is a four-arm, double-blind, randomized controlled clinical trial. Experimental group 1: 35 non-carious cervical lesions (NCCL) using an alcohol- and water-based solvent universal adhesive with evaporation of solvent for 25 seconds. Experimental group 2: 35 NCCL using an acetone-based universal solvent adhesive with solvent evaporation for 25 seconds. Control group 1: 35 NCCL using an alcohol- and water-based universal solvent adhesive with evaporation of solvent for 5 seconds. Control group 2: 35 NCCL using an acetone-based universal solvent adhesive with solvent evaporation for 5 seconds. LCNCs will be randomized to universal adhesive usage and evaporation time.This is a four-arm, double-blind, randomized controlled clinical trial. Experimental group 1: 35 non-carious cervical lesions (NCCL) using an alcohol- and water-based solvent universal adhesive with evaporation of solvent for 25 seconds. Experimental group 2: 35 NCCL using an acetone-based universal solvent adhesive with solvent evaporation for 25 seconds. Control group 1: 35 NCCL using an alcohol- and water-based universal solvent adhesive with evaporation of solvent for 5 seconds. Control group 2: 35 NCCL using an acetone-based universal solvent adhesive with solvent evaporation for 5 seconds. LCNCs will be randomized to universal adhesive usage and evaporation time.

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Masking Description:

Two blinded, experienced, and calibrated dentists (who specialized in esthetic dentistry with more than 15 years of clinical practice), will perform the clinical evaluation. Patients will be also blinded to group assignment. An inter-examiner and inter-examiner agreement of at least 85% will be necessary before beginning the evaluation

Primary Purpose:

Treatment

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

Actual Study Start Date :

Mar 30, 2023

Actual Primary Completion Date :

Jun 23, 2023

Actual Study Completion Date :

Jun 23, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental group 1 35 non-carious cervical lesions (NCCL) will receive composite resin restorations in the selective enamel etching strategy.	Procedure: 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. Other Names: Evaporation time of solvent 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). Other Names: alcohol/water-based adhesive
Experimental: Experimental group 2 35 non-carious cervical lesions (NCCL) will receive composite resin restorations in the selective enamel etching strategy.	Procedure: 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. Other Names: Evaporation time of solvent for 25 seconds Device: 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). Other Names: acetone universal adhesive
Active Comparator: Control group 1 35 non-carious cervical lesions (NCCL) will receive composite resin restorations in the selective enamel etching strategy.	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. Other Names: Evaporation time of solvent for 5 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). Other Names: alcohol/water-based adhesive
Active Comparator: Control group 2 35 non-carious cervical lesions (NCCL) will receive composite resin restorations in the selective enamel etching strategy.	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. Other Names: Evaporation time of solvent for 5 seconds Device: 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). Other Names: acetone universal adhesive

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.