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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
  Purpose

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 Intervention
Dental Caries
Device: Adhesive A
Device: Adhesive B
Device: Adhesive C

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Evaluation of Three Dental Adhesive Systems in Class V Restorations

Resource links provided by NLM:


Further study details as provided by 3M:

Primary Outcome Measures:
  • Retention of the restoration. [ Time Frame: 6, 12, 24, 36 months post-placement ] [ Designated as safety issue: No ]

Enrollment: 46
Study Start Date: April 2008
Study Completion Date: June 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Adhesive A Device: Adhesive A
Applied per manufacturer's instructions.
Other Name: Adper Scotchbond SE (3M ESPE)
Adhesive B Device: Adhesive B
Applied per manufacturer's instructions.
Other Name: Adper Easy Bond (3M ESPE)
Adhesive C Device: Adhesive C
Applied per manufacturer's instructions.
Other Name: Single Bond Plus (3M ESPE)

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Class V cavities

Criteria

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
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: NCT00643461

Locations
United States, Alabama
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
  More Information

No publications provided

Responsible Party: 3M
ClinicalTrials.gov Identifier: NCT00643461     History of Changes
Other Study ID Numbers: CR-07-009
Study First Received: March 20, 2008
Last Updated: April 16, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 27, 2014