DPBRN Longitudinal Study of Questionable Occlusal Caries Lesions

• Sponsor: Dental Practice-Based Research Network (Other)
• Overall Status: Completed
• CT.gov ID: NCT01309971
• Collaborator: HealthPartners Institute (Other), Kaiser Permanente (Other), Permanente Dental Associates Group, Oregon (Other), National Institute of Dental and Craniofacial Research (NIDCR) (NIH)
• Enrollment: 2,624
• Locations: 7
• Duration (Months): 40
• Patients Per Site: 374.9
• Patients Per Site Per Month: 9.4

Study Details

Study Description

Brief Summary

The purpose of this study will allow us to observe and follow the subjects' treatment from DPBRN Prevalence of Questionable Occlusal Caries Lesions Study over a 24 month period.

Condition or Disease	Intervention/Treatment	Phase
Dental Caries

Detailed Description

There have been very few studies regarding questionable lesions, virtually no clinical evaluations of the progression of questionable lesions over time, and no studies depicting the prevalence of these lesions. Since carious lesions have the ability to arrest and possibly reverse, determining how often these lesions are being seen in practice and learning more about their characteristics and patient risk assessment are important steps in order to manage these lesions without unnecessary surgical intervention.

Study Design

• Study Type: Observational
• Actual Enrollment: 2624 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Longitudinal Study of Questionable Occlusal Caries Lesions
• Study Start Date: Aug 1, 2008
• Actual Primary Completion Date: Mar 1, 2010
• Actual Study Completion Date: Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Questionable occlusal lesions

Outcome Measures

Primary Outcome Measures

1. Questionable Caries [24 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 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.

Exclusion Criteria:

• patients under 6 years old

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294-0007
2	University of Florida College of Dentistry	Gainesville	Florida	United States	32610
3	Health Partners Dental Group	Minneapolis	Minnesota	United States	55440-1309
4	Health Partners Research Foundation	Minneapolis	Minnesota	United States	55440-1524
5	Kaiser Permanente Center for Health Research	Portland	Oregon	United States	97227
6	Permanente Denrtal Associates	Portland	Oregon	United States	97232
7	University of Copenhagen Royal Dental College	Copenhagen		Denmark

Sponsors and Collaborators

• Dental Practice-Based Research Network
• HealthPartners Institute
• Kaiser Permanente
• Permanente Dental Associates Group, Oregon
• National Institute of Dental and Craniofacial Research (NIDCR)

Investigators

• Principal Investigator: Sonia K Makhija, DDS, MPH, University of Alabama at Birmingham

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Dental Practice-Based Research Network

Publications

None provided.

• Responsible Party: Dental Practice-Based Research Network
• ClinicalTrials.gov Identifier: NCT01309971
• Other Study ID Numbers: 122012; U01DE016747
• First Posted: Mar 7, 2011
• Last Update Posted: Feb 19, 2014
• Last Verified: Feb 1, 2014

• Keywords provided by Dental Practice-Based Research Network: Assessment; Questionable Caries
• Additional relevant MeSH terms: Dental Caries

Study Results

No Results Posted as of Feb 19, 2014