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

Universidad de los Andes, Chile

Status: Completed

Conditions: Non-carious Cervical Lesions

Treatments: Procedure: Evaporation time for 5 seconds; Device: alcohol/water-based universal adhesive; Procedure: Evaporation time for 25 seconds; Device: acetone-based universal adhesive

Study type: Interventional

Funder types: Other

Identifiers

NCT05945173

CEC2022129

Details and patient eligibility

About

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).

Full 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.).

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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35 participants in 4 patient groups

Experimental group 1

Experimental group

Description:

35 non-carious cervical lesions (NCCL) will receive composite resin restorations in the selective enamel etching strategy.

Treatment:

Procedure: Evaporation time for 25 seconds

Device: alcohol/water-based universal adhesive

Experimental group 2

Experimental group

Description:

35 non-carious cervical lesions (NCCL) will receive composite resin restorations in the selective enamel etching strategy.

Treatment:

Device: acetone-based universal adhesive

Procedure: Evaporation time for 25 seconds

Control group 1

Active Comparator group

Description:

35 non-carious cervical lesions (NCCL) will receive composite resin restorations in the selective enamel etching strategy.

Treatment:

Device: alcohol/water-based universal adhesive

Procedure: Evaporation time for 5 seconds

Control group 2

Active Comparator group

Description:

35 non-carious cervical lesions (NCCL) will receive composite resin restorations in the selective enamel etching strategy.

Treatment:

Device: acetone-based universal adhesive

Procedure: Evaporation time for 5 seconds