NCT00643461

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 26, 2008

Completed
6 days until next milestone

Study Start

First participant enrolled

April 1, 2008

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

October 2, 2024

Status Verified

September 1, 2024

Enrollment Period

3.8 years

First QC Date

March 20, 2008

Last Update Submit

September 30, 2024

Conditions

Dental Caries

Outcome Measures

Primary Outcomes (1)

  • Retention of the restoration.

    6, 12, 24, 36 months post-placement

Study Arms (3)

Adhesive A

Device: Adhesive A

Adhesive B

Device: Adhesive B

Adhesive C

Device: Adhesive C

Interventions

Adhesive ADEVICE

Applied per manufacturer's instructions.

Also known as: Adper Scotchbond SE (3M ESPE)
Adhesive A
Adhesive BDEVICE

Applied per manufacturer's instructions.

Also known as: Adper Easy Bond (3M ESPE)
Adhesive B
Adhesive CDEVICE

Applied per manufacturer's instructions.

Also known as: Single Bond Plus (3M ESPE)
Adhesive C

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Class V cavities

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham (UAB) School of Dentistry

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • John O Burgess, MS, DDS

    University of Alabama at Birmingham (UAB) School of Dentistry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2008

First Posted

March 26, 2008

Study Start

April 1, 2008

Primary Completion

February 1, 2012

Study Completion

June 1, 2012

Last Updated

October 2, 2024

Record last verified: 2024-09

Locations

US(1)