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OpenTrials
Completed

NCT Number: NCT01369134

Clinical Evaluation of a Self-etch Adhesive Using a Selective Etch Technique

Study hypothesis: Etching the enamel followed by use of a self-etching adhesive on enamel and dentin is as effective as a one-step etch and rinse approach.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

School of Dental Medicine

Buffalo, New York, 14214, United States

About this study

There is scant evidence available on the performance of self-etching dental adhesive systems. This study aims to clinically evaluate a self-etch adhesive used either with an extra enamel etching step, or in a self-etch stand alone technique with no extra enamel etch.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18 years or older
  • written informed consent
  • regular dental attender, can return to clinic for study recalls
  • good medical health
  • normal saliva flow
  • has one or two pairs of back teeth that require a Class I or II restoration of appropriate size
  • study teeth that are vital

Exclusion criteria

  • currently in an evaluation of other dental materials
  • an irregular dental attender
  • has unacceptable oral hygiene standards
  • has chronic periodontitis or rampant caries
  • has teeth with signs of periapical pathology
  • has history of pulp problems, and/or needs pulp treatment
  • women who are pregnant or breast-feeding
  • has known allergy to resin composite or latex
  • has serious chronic disease requiring hospitalization
  • has oral soft tissue pathologies
  • takes medications which, in the opinion of the investigator, could interfere with the conduct of the study
  • has current or recent history of alcohol or other substance abuse
  • is an employee of the sponsor or the study site, or members of their immediate family
  • has had any restorative treatment of teeth involved in the study in the last twelve months

Treatment and study plan

Adper Easy Bond Self-etch dental adhesive

Device

Bonding composite to restore Class I or Class II cavities

Other names: self etch adhesive with enamel etch

Primary outcomes

  1. Retention of the Restoration

    Time frame: one year

    Bonded filling still in place

Secondary outcomes

  1. Clinical performance of the study restoration

    Time frame: one year

    Restoration in satisfactory clinical function at one year

Sponsors and collaborators

Lead sponsor

Solventum US LLC

Industry

Collaborators

  • 3M

Registry information

Official study title

Clinical Evaluation of 3M ESPE Adper Easy Bond Self-Etch Adhesive Using a Selective Etch Technique

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jun 8, 2011
Registry last updated
Oct 2, 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.

Published trials that share one or more normalized conditions with this study.