DPBRN Development of a Patient Based Provider Interventio... | NCT01309958

Studies
DPBRN Development of a Patient Based Provider Intervention for Early Caries Management

NCT01309958

Sponsor

Dental Practice-Based Research Network

Status

Completed

Last Update Posted

Aug 6, 2015Estimated

Enrollment

334Actual

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

Aug 2015

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

Jun 2008

Primary Completion Date

Oct 2010Actual

Completion Date

Oct 2010Actual

First Submitted Date

Mar 4, 2011

First Submission Date that Met QC Criteria

Mar 4, 2011

First Posted Date

Mar 7, 2011Estimated

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

Aug 5, 2015

Last Update Posted Date

Aug 6, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Gregg H. Gilbert, DDS, MBA, FAAHD, Study Chair, University of Alabama at Birmingham, Dental Practice-Based Research NetworkPrincipal Investigator

Lead Sponsor

Dental Practice-Based Research NetworkNETWORK

Collaborators

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

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

This study focused on improving the quality of dental care by fostering movement of the latest scientific advances into daily clinical practice.

Detailed Description

Phase 1 - development of two instruments (a patient brochure that described non-invasive caries treatment and a patient questionnaire of satisfaction with non-invasive caries treatment).

Phase 2 - field tested the patient brochure

Phase 3 - pilot tested the patient brochure, quantifying patient satisfaction with non-invasive caries treatments and a feasibility study that will inform the design of a clinical trial in dental practices envisioned for a later study.

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

334Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
intervention		design instruments and test feasibility of an intervention aimed at increasing the proportion on non-invasive treatment for early caries

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

dentists enrolled in the Dental Practice-Based Research Network (DPBRN) who participated in DPBRN Assessment of Caries Diagnosis & Caries Treatment and DBPRN Reasons for placing the First Restoration on Permanent Tooth Surfaces

Exclusion Criteria:

patients under 19 years of age

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

ghg@uab.edu

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gregg H Gilbert, DDS, MBA	National Dental PBRN	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