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Clinical Evaluation of Three Dental Adhesive Systems in Class V Restorations

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00643461
First Posted: March 26, 2008
Last Update Posted: April 18, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
3M
March 20, 2008
March 26, 2008
April 18, 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 ]
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
Sexes Eligible for Study: All
19 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00643461
CR-07-009
No
Not Provided
Not Provided
3M
3M
Not Provided
Principal Investigator: John O Burgess, MS, DDS University of Alabama at Birmingham (UAB) School of Dentistry
3M
April 2013