DPBRN Longitudinal Study of Repaired or Replaced Dental R... | NCT01201395

Studies
DPBRN Longitudinal Study of Repaired or Replaced Dental Restorations

NCT01201395

Sponsor

Dental Practice-Based Research Network

Status

Completed

Last Update Posted

Sep 20, 2011Estimated

Enrollment

9,813Estimated

Phase

Not provided

Conditions

Dental Caries

Interventions

Not provided

Countries

United States
Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
U01DE016747	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Sep 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2009

Primary Completion Date

Sep 2011Actual

Completion Date

Sep 2011Actual

First Submitted Date

Sep 13, 2010

First Submission Date that Met QC Criteria

Sep 13, 2010

First Posted Date

Sep 14, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 16, 2011

Last Update Posted Date

Sep 20, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Gregg H. Gilbert, DDS, MBA, FAAHD, Professor and Chair, Department of General Dental Sciences, Dental Practice-Based Research NetworkPrincipal Investigator

Lead Sponsor

Dental Practice-Based Research NetworkNETWORK

Collaborators

Name	Class
National Institute of Dental and Craniofacial Research (NIDCR)	NIH
HealthPartners Institute	OTHER
Kaiser Permanente	OTHER
Permanente Dental Associates Group, Oregon

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to assess the quality and expected lifespan of fillings recorded in the DPBRN "Reasons for replacement and repair of dental restorations" study, and the factors affecting how long the fillings last.

Detailed Description

The study is an observational follow-up of previously placed dental restorations (fillings)and is conducted during routing dental care visits.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

9,813Estimated

Label	Type	Description	Intervention Names
Dental caries assessment

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

participant in the DPBRN "Reasons for replacement or repair of dental restorations" study

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

The participants directly involved in this study are the particpants who have sought dental treatment in the practitioner-investigators' practices and participated in the DPBRN "Reasons for replacement or repair of dental restorations" study.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Valeria V Gordan, DDS, MS	University of Florida	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham		Birmingham	Alabama	35294-0007	United States
University of Florida College of Dentistry

Label	URL
Dental Practice-Based Research Network	View source

Condition Browse Module

MeSH Terms

ID	Term
D003731	Dental Caries

Ancestor Terms

ID	Term
D017001	Tooth Demineralization
D014076	Tooth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided