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Completed

NCT Number: NCT05945173

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

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).

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Key information

Conditions

Non-carious Cervical Lesions Stomatognathic Diseases Tooth Demineralization Tooth Diseases Tooth Erosion Tooth Wear

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mario Felipe Gutiérrez Reyes

Santiago, Santiago Metropolitan, 7620086, Chile

About this study

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.).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Evaporation time for 5 seconds

Procedure

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

Evaporation time for 25 seconds

Procedure

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

alcohol/water-based universal adhesive

Device

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

acetone-based universal adhesive

Device

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

Primary outcomes

  1. Retention of restorations

    Time frame: 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 outcomes

  1. Marginal Adaptation of restorations

    Time frame: 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.

  2. Marginal Staining of restorations

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Universidad de los Andes, Chile

Other

Collaborators

  • Agencia Nacional de Investigación y Desarrollo

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 14, 2023
Registry last updated
Jul 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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