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Clinical Evaluation of Three Dental Adhesive Systems in Class V Restorations

Sponsor
3M (Industry)
Overall Status
Completed
CT.gov ID
NCT00643461
Collaborator
(none)
46
Enrollment
1
Location
50
Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the clinical performance of three dental adhesive systems used to bond Class V cavity fillings in adult teeth.

Condition or Disease Intervention/Treatment Phase
  • Device: Adhesive A
  • Device: Adhesive B
  • Device: Adhesive C

Study Design

Study Type:
Observational
Actual Enrollment :
46 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Clinical Evaluation of Three Dental Adhesive Systems in Class V Restorations
Study Start Date :
Apr 1, 2008
Actual Primary Completion Date :
Feb 1, 2012
Actual Study Completion Date :
Jun 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Adhesive A

Device: Adhesive A
Applied per manufacturer's instructions.
Other Names:
  • Adper Scotchbond SE (3M ESPE)

    		•
    Adhesive B

    Device: Adhesive B
    Applied per manufacturer's instructions.
    Other Names:
  • Adper Easy Bond (3M ESPE)

    		•
    Adhesive C

    Device: Adhesive C
    Applied per manufacturer's instructions.
    Other Names:
  • Single Bond Plus (3M ESPE)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Retention of the restoration. [6, 12, 24, 36 months post-placement]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Must be at least 19 years of age

    • Must have at least 3 qualifying noncarious Class V lesions of appropriate depth

    • Must be willing to sign consent form

    • Must be willing and able to return to UAB clinic for 4 study appointments

    • Must be in good medical health and able to tolerate dental procedures

    Exclusion Criteria:

    • Current participation in other restorative product studies

    • Severe salivary gland dysfunction

    • Rampant caries (cavities)

    • Chronic periodontitis (gum disease)

    • Known allergies to the study materials

    • Unacceptable level of oral hygiene

    • Inability or unwillingness to attend study appointments

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham (UAB) School of Dentistry Birmingham Alabama United States 35294

    Sponsors and Collaborators

    • 3M

    Investigators

    • Principal Investigator: John O Burgess, MS, DDS, University of Alabama at Birmingham (UAB) School of Dentistry

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    3M
    ClinicalTrials.gov Identifier:
    NCT00643461
    Other Study ID Numbers:
    • CR-07-009
    First Posted:
    Mar 26, 2008
    Last Update Posted:
    Apr 18, 2013
    Last Verified:
    Apr 1, 2013
    Additional relevant MeSH terms:
    Dental Caries

    Study Results

    No Results Posted as of Apr 18, 2013