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Completed

NCT Number: NCT06465849

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

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).

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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–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mario Felipe Gutiérrez Reyes

Santiago, Santiago Metropolitan, 8360053, 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 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.

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

Dentin Etching time for 5 seconds

Procedure

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.

Scotchbond Universal Plus; 3M

Device

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

Gluma Universal Bond; Kulzer

Device

Composite resin restorations of non-carious cervical lesions will be performed with an universal adhesive (Gluma Universal Bond; Kulzer).

Dentin Etching time for 15 seconds

Procedure

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.

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 20, 2024
Registry last updated
Jun 20, 2024

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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