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
  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: Observational
Study Design: Time Perspective: Prospective
Official Title: Clinical Evaluation of 3M ESPE Adper Easy Bond Self-Etch Adhesive Using a Selective Etch Technique

Resource links provided by NLM:


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


Enrollment: 40
Study Start Date: January 2011
Study Completion Date: February 2013
Primary Completion Date: February 2013 (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 adhesive with enamel etch
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Dental patients

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: May 29, 2014
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 September 22, 2014