Clinical Evaluation of Three Dental Adhesive Systems in Class V Restorations

This study is ongoing, but not recruiting participants.

First Received: March 20, 2008 Last Updated: December 29, 2008 History of Changes

Sponsored by:	3M
Information provided by:	3M
ClinicalTrials.gov Identifier:	NCT00643461

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: 3M ESPE Adper Scotchbond SE Device: 3M ESPE Adper Easy Bond Device: 3M ESPE Single Bond Plus

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Parallel Assignment

Further study details as provided by 3M:

Primary Outcome Measures:

Retention of the restoration.

Estimated Enrollment:	45
Study Start Date:	April 2008
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Device: 3M ESPE Adper Scotchbond SE
B: Experimental	Device: 3M ESPE Adper Easy Bond
C: Active Comparator	Device: 3M ESPE Single Bond Plus

Eligibility

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

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

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 ESPE Dental Products ( 3M ESPE Clinical Research )
Study ID Numbers:	CR-07-009
Study First Received:	March 20, 2008
Last Updated:	December 29, 2008
ClinicalTrials.gov Identifier:	NCT00643461 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Tooth Diseases
Stomatognathic Diseases
Dental Caries

Additional relevant MeSH terms:

Tooth Diseases
Stomatognathic Diseases
Tooth Demineralization
Dental Caries

ClinicalTrials.gov processed this record on September 04, 2009