Clinical Evaluation of Three Dental Adhesive Systems in Class V Restorations

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
3M
ClinicalTrials.gov Identifier:
NCT00643461
First received: March 20, 2008
Last updated: April 16, 2013
Last verified: April 2013

March 20, 2008
April 16, 2013
April 2008
February 2012   (final data collection date for primary outcome measure)
Retention of the restoration. [ Time Frame: 6, 12, 24, 36 months post-placement ] [ Designated as safety issue: No ]
Retention of the restoration.
Complete list of historical versions of study NCT00643461 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Clinical Evaluation of Three Dental Adhesive Systems in Class V Restorations
Clinical Evaluation of Three Dental Adhesive Systems in Class V Restorations

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Class V cavities

Dental Caries
  • Device: Adhesive A
    Applied per manufacturer's instructions.
    Other Name: Adper Scotchbond SE (3M ESPE)
  • Device: Adhesive B
    Applied per manufacturer's instructions.
    Other Name: Adper Easy Bond (3M ESPE)
  • Device: Adhesive C
    Applied per manufacturer's instructions.
    Other Name: Single Bond Plus (3M ESPE)
  • Adhesive A
    Intervention: Device: Adhesive A
  • Adhesive B
    Intervention: Device: Adhesive B
  • Adhesive C
    Intervention: Device: Adhesive C
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
46
June 2012
February 2012   (final data collection date for primary outcome measure)

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
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00643461
CR-07-009
No
3M
3M
Not Provided
Principal Investigator: John O Burgess, MS, DDS University of Alabama at Birmingham (UAB) School of Dentistry
3M
April 2013

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