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

NCT07034235 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-06-24

No results posted yet for this study

Summary

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).

Conditions

  • Non-carious Cervical Lesions

Interventions

PROCEDURE

Dentin Wet

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

PROCEDURE

Dentin Overwet

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

DEVICE

Ambar Universal APS Plus; FGM

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

DEVICE

Prime&Bond Active; Dentsply Sirona

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

Sponsors & Collaborators

  • Universidade Estadual de Ponta Grossa

    collaborator OTHER
  • Universidad de los Andes, Chile

    lead OTHER

Principal Investigators

  • Mario Gutierrez, PhD · Universidad de los Andes, Chile

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-01-06
Primary Completion
2025-03-03
Completion
2025-03-10

Countries

  • Chile

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07034235 on ClinicalTrials.gov