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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
3M
ClinicalTrials.gov Identifier:
NCT01369134
First received: June 7, 2011
Last updated: July 24, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention
Dental Caries
 Device: Adper Easy Bond Self-etch dental adhesive

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of 3M ESPE Adper Easy Bond Self-Etch Adhesive Using a Selective Etch Technique

Resource links provided by NLM:

MedlinePlus related topics: Tooth Decay
U.S. FDA Resources

Further study details as provided by 3M:

Primary Outcome Measures:
  • Retention of the Restoration [ Time Frame: one year ] [ Designated as safety issue: No ]
    Bonded filling still in place


Secondary Outcome Measures:
  • Clinical performance of the study restoration [ Time Frame: one year ] [ Designated as safety issue: No ]
    Restoration in satisfactory clinical function at one year


Estimated Enrollment: 40
Study Start Date: January 2011
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Adper Easy Bond Self-etch dental adhesive
    Bonding composite to restore Class I or Class II cavities
    Other Name: self etch adhesbive with enamel etch
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01369134

Locations
United States, New York
School of Dental Medicine
Buffalo, New York, United States, 14214
Sponsors and Collaborators
3M
Investigators
Principal Investigator: Carlos Munoz, DDS Dental Clinic Research Center, School of Dental Medicine, 215 Squire Hall, 3435 Main St, Buffalo, NY 14214
  More Information

No publications provided

Responsible Party: 3M
ClinicalTrials.gov Identifier: NCT01369134     History of Changes
Other Study ID Numbers: CR-10-014
Study First Received: June 7, 2011
Last Updated: July 24, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by 3M:
self-etch adhesive
selective enamel etching
Adper Easy Bond
Supreme Ultra
 Molar and premolar teeth
Adult
Class I and II cavities

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on May 16, 2013