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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
3M
ClinicalTrials.gov Identifier:
NCT01369134
First received: June 7, 2011
Last updated: May 29, 2014
Last verified: May 2014

June 7, 2011
May 29, 2014
January 2011
February 2013   (final data collection date for primary outcome measure)
Retention of the Restoration [ Time Frame: one year ] [ Designated as safety issue: No ]
Bonded filling still in place
Same as current
Complete list of historical versions of study NCT01369134 on ClinicalTrials.gov Archive Site
Clinical performance of the study restoration [ Time Frame: one year ] [ Designated as safety issue: No ]
Restoration in satisfactory clinical function at one year
Same as current
Not Provided
Not Provided
 
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.

Observational
Time Perspective: Prospective
Not Provided
Not Provided
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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01369134
CR-10-014
No
3M
3M
Not Provided
Principal Investigator: Carlos Munoz, DDS Dental Clinic Research Center, School of Dental Medicine, 215 Squire Hall, 3435 Main St, Buffalo, NY 14214
3M
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP