NCT01201447

Brief Summary

The purpose of this study was to investigate the process involved when making decisions about the diagnosis and treatment of questionable lesions, as well as determine if there is any association between lesions progression (or depth, if opened) and clinical characteristics and baseline risk assessment.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
2,624

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2008

Geographic Reach
2 countries

7 active sites

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

Study Start

First participant enrolled

August 1, 2008

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 14, 2010

Completed
Last Updated

March 4, 2011

Status Verified

March 1, 2011

Enrollment Period

1.6 years

First QC Date

September 13, 2010

Last Update Submit

March 3, 2011

Conditions

Keywords

AssessmentQuestionable Caries

Study Arms (1)

Questionable occlusal lesions

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The participants directly involved in this study were the patients who have sought dental treatment in the DPBRN practitioner-investigators' practices.

You may qualify if:

  • patients needed to have at least one permanent tooth with a questionable lesion. This means that subjects were at least 6 years old because that is when the permanent first molar typically erupts.

You may not qualify if:

  • patients under 6 years old
  • patients 6 years old and older who do not have a questionable lesion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

University of Florida College of Dentistry

Gainesville, Florida, 32610, United States

Location

Health Partners Dental Group

Minneapolis, Minnesota, 55440-1309, United States

Location

Health Partners Research Foundation

Minneapolis, Minnesota, 55440-1524, United States

Location

Kaiser Permanente Center for Health Research

Portland, Oregon, 97227, United States

Location

Permanente Denrtal Associates

Portland, Oregon, 97232, United States

Location

University of Copenhagen Royal Dental College

Copenhagen, Denmark

Location

Related Links

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Sonia K Makhija, DDS, MPH

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
NETWORK

Study Record Dates

First Submitted

September 13, 2010

First Posted

September 14, 2010

Study Start

August 1, 2008

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

March 4, 2011

Record last verified: 2011-03

Locations