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Completed

NCT Number: NCT07034235

Effect of Wet and Overwet Dentin on the Clinical Performance of Two Universal Adhesive Systems

The aim of this study will be to evaluate the effect of wet and overwet dentin on the long-term clinical performance of two universal adhesive systems used as etch-and-rinse application mode in non-carious cervical lesions (NCCLs).

Materials & Methods: 200 restorations will be randomly placed in 50 subjects according to the following groups (n=50): AMP-wet (Ambar Universal APS Plus adhesive on wet dentin); AMP-overwet (Ambar Universal APS Plus adhesive on oversaturated dentin); PBA-wet (Prime&Bond Active adhesive on wet dentin); PBA-overwet (Prime&Bond Active adhesive on oversaturated dentin). For all groups, the enamel and dentin will be etched for 15s. 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 was light cured for 20s/1,000 mW/cm2. The restorations will be finished immediately with fine diamond burs and spiral polishers. The restorations will be evaluated at baseline and after 6 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.

Control group 1: 50 non-carious cervical lesions (NCCL) will receive composite resin restorations using an universal adhesive (Ambar Universal APS Plus; FGM) on wet dentin in the etch-and-rinse application strategy.

Control group 2: 50 non-carious cervical lesions (NCCL) will receive composite resin restorations using an universal adhesive (Prime&Bond Active; Dentsply Sirona) on wet dentin in the etch-and-rinse application strategy.

Experimental group 1: 50 non-carious cervical lesions (NCCL) will receive composite resin restorations using an universal adhesive (Ambar Universal APS Plus; FGM) on overwet dentin in the etch-and-rinse application strategy.

Experimental group 2: 50 non-carious cervical lesions (NCCL) will receive composite resin restorations using an universal adhesive (Prime&Bond Active; Dentsply Sirona) on overwet dentin in the etch-and-rinse application strategy

LCNCs will be randomized to universal adhesive usage and dentinal moisture levels. All groups will be light-cured with a lightcuring device (Quazar, FGM) with a light intensity of 900 mW/cm² for 10 seconds. Operators will restore the cervical area by applying three increments of resin (Llis-FGM for experimental groups 1 and 2; and TPH Spectrum-Dentsply for experimental groups 3 and 4). Each increment will light cure for 20 s at 900 mW/cm2 (Quazar, FGM). Restorations will be finished immediately with fine and extra fine diamond burs and polished with polishing spirals.

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.

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 Wet

Procedure

Composite resin restorations of non-carious cervical lesions will be performed with an adhesive on wet dentin in the etch-and-rinse application strategy.

Dentin Overwet

Procedure

Composite resin restorations of non-carious cervical lesions will be performed with an adhesive on overwet dentin in the etch-and-rinse application strategy.

Ambar Universal APS Plus; FGM

Device

Composite resin restorations of non-carious cervical lesions will be performed with an universal adhesive

Prime&Bond Active; Dentsply Sirona

Device

Composite resin restorations of non-carious cervical lesions will be performed with an universal adhesive

Primary outcomes

  1. Retention of restorations

    Time frame: From date of randomization until thirty-six 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 thirty six 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 thirty six 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

  • Universidade Estadual de Ponta Grossa

Registry information

Official study title

Clinical Evaluation of the Effect of Wet and Overwet Dentin Using Two Universal Adhesives in Restorations of Non-carious Cervical Lesions: Double Blind Randomized Clinical Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 24, 2025
Registry last updated
Jun 24, 2025

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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