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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01369134
Recruitment Status : Completed
First Posted : June 8, 2011
Last Update Posted : May 30, 2014
Information provided by (Responsible Party):

June 7, 2011
June 8, 2011
May 30, 2014
January 2011
February 2013   (Final data collection date for primary outcome measure)
Retention of the Restoration [ Time Frame: one year ]
Bonded filling still in place
Same as current
Complete list of historical versions of study NCT01369134 on Archive Site
Clinical performance of the study restoration [ Time Frame: one year ]
Restoration in satisfactory clinical function at one year
Same as current
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Clinical Evaluation of a Self-etch Adhesive Using a Selective Etch Technique
Clinical Evaluation of 3M ESPE Adper Easy Bond 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.
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.
Time Perspective: Prospective
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Non-Probability Sample
Dental patients
Dental Caries
Device: Adper Easy Bond Self-etch dental adhesive
Bonding composite to restore Class I or Class II cavities
Other Name: self etch adhesive with enamel etch
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
February 2013
February 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Principal Investigator: Carlos Munoz, DDS Dental Clinic Research Center, School of Dental Medicine, 215 Squire Hall, 3435 Main St, Buffalo, NY 14214
May 2014