MedTrace Logo

BONDING TO ENAMEL USING A UNIVERSAL ADHESIVE

NCT03254693 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2017-08-29

No results posted yet for this study

Summary

Objective: This double-blind randomized clinical trial evaluates strategies for improving the bonding of universal adhesive to enamel in non-carious cervical lesions (NCCL) of a new universal multi-mode adhesive (Ambar Universal; FGM).

Methods: A total of 134 restorations were randomly placed in 19 patients according to the following groups: SE - Self-etch; SEE - Selective etching; SE2X - Self-etch doble time; SE1+ - Self-etch additional layer. The resin composite Opallis (FGM) was placed incrementally. The restorations were evaluated after one week (baseline), 6 and 12 months, using the FDI and USPHS criteria. Statistical analyses were performed using appropriate tests (=0.05).

Conditions

  • Clinical Trial

Interventions

COMBINATION_PRODUCT

1-step self-etch approach (SE)

Application mode - Do not use etchan. According to the manufacturer's instructions.

COMBINATION_PRODUCT

selective enamel etching (SEE)

Application mode - Etch only on enamel for 15 s. Rinse for 15s. Air dry to remove excess water.According to the manufacturer's instructions.

OTHER

1-step self-etch for double time (SE2X)

Application mode - Do not use etchan. According to the manufacturer's instructions, but for the double time (20 s) in the each application.

OTHER

1-step self-etch additional layer (SE1+)

Application mode - Do not use etchan. According to the manufacturer's instructions, but apply tree times.

Sponsors & Collaborators

  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

    collaborator OTHER_GOV

  • Universidade Estadual de Ponta Grossa

    lead OTHER

Principal Investigators

  • Rafael Scheffer, Master · Universidade Estadual do Oeste do Paraná

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-02-01
Primary Completion
2017-08-01
Completion
2017-08-01

Countries

  • Brazil

Study Locations

More Related Trials

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 NCT03254693 on ClinicalTrials.gov