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Clinical Evaluation of Three Dental Adhesive Systems in Class V Restorations

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ClinicalTrials.gov Identifier: NCT00643461
Recruitment Status : Completed
First Posted : March 26, 2008
Last Update Posted : April 18, 2013
Sponsor:
Information provided by (Responsible Party):

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
Dental Caries 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 : April 2008
Primary Completion Date : February 2012
Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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)


Outcome Measures

Primary Outcome Measures :
  1. Retention of the restoration. [ Time Frame: 6, 12, 24, 36 months post-placement ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: 3M
ClinicalTrials.gov Identifier: NCT00643461     History of Changes
Other Study ID Numbers: CR-07-009
First Posted: March 26, 2008    Key Record Dates
Last Update Posted: April 18, 2013
Last Verified: April 2013

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