Dental CariesNCT00847470
DPBRN Reasons for Placing the First Restoration on Permanent Tooth Surfaces
An observational study of Dental Caries, run by Dental Practice-Based Research Network at 7 sites in 2 countries.
Trial summary
The purpose of this study was to document the reasons for placing the first restoration ("filling") on a previously un-restored surface in a permanent ("adult") tooth. Read more about this study
- Who is it for?
- Ages 6 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- How many people
- 5,810 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Jun 2006to Dec 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Practitioner investigators must have been enrolled in the DPBRN, completed the "Assessment of caries diagnosis \& caries treatment" study; and do at least some restorative dentistry in their practices. The human subjects directly involved in this study were patients who had sought treatment in the DPBRN practitioners' practices.
Who may be able to join
- participants directly involved in this study were patients who sought dental treatment in the practitioner-investigators' practices
- any tooth surface that was previously unrestored was eligible for this study, provided that it was on a permanent ("adult") tooth. This means that permanent first molars were eligible, which typically erupt at about age 6 years. This means that persons age 6 and older were enrolled in the study and there was no upper age limit.
Who cannot join
None listed.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States6 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294
University of Florida College of Dentistry
Gainesville, Florida
Health Partners Dental Group
Minneapolis, Minnesota
Health Partners Research Foundation
Minneapolis, Minnesota
Kaiser Permanente Center for Health Research
Portland, Oregon
Permanente Denrtal Associates
Portland, Oregon
About this study
Official title: Reasons for Placing the First Restoration on Permanent Tooth Surfaces
The purpose of this study was to document the reasons for placing the first restoration ("filling") on a previously un-restored surface in a permanent ("adult") tooth.
Read the detailed description
The aims of this study were to (1) quantify DPBRN practitioner-investigators pre-operative and post-operative assessments of the depth of the caries lesion being treated; (2) quantify the prevalence of dental material types used to restore the first restoration in a permanent tooth surface; and (3) test the hypothesis that DPBRN practitioner investigators in the "Assessment of caries diagnosis and caries treatment" study who stated that they wait until the caries lesions reach dentin before they place the first restoration are in fact more likely in this study to do restoration in teeth that have caries reaching into dentin.
The aims were met by enrolling 230 DPBRN practitioner-investigators in the "Reasons for placing the first restoration on permanent tooth surfaces" study, each of whom recorded information about approximately 50 consecutive restorations that they placed on unrestored surfaces. This study about restorative treatment received by patients provided the opportunity to record the variations in the treatment provided, and also provided a basis for subsequent future studies to investigate how defects on fillings develop over time. These results will also be related to the findings from "Assessment of caries diagnosis and caries treatment" study where practitioners outlined how they detected dental decay, the stage at which the decay was treated by placing fillings, and how they rely on preventive measures to stop the decay process without placing fillings.
- Conditions
- Dental Caries
- Keywords
- Dental caries, Assessments, dental materials
- Medical subject headings
- Dental Caries
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2009 (estimated)
- Study startJun 2006
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 5,810 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dental Practice-Based Research Network
- Sponsor type
- Research network
- Collaborators
- HealthPartners Institute, Kaiser Permanente, Permanente Dental Associates Group, Oregon, University of Copenhagen, University of Florida, University of North Carolina, Chapel Hill
- Responsible party
- Principal investigator, Gregg H. Gilbert, DDS, MBA, FAAHD, Dental Practice-Based Research Network
- Investigators
- Gregg H. Gilbert, DDS, MBA, Study chair, Dental Practice-Based Research NetworkValeria V. Gordan, DDS, MS, MSCI, Principal investigator, Dental Practice-Based Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00847470
- Sponsor's protocol ID
- 101883
- Status last verified
- Nov 2014
- First submitted
- 17 Feb 2009
- Last updated
- 18 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Litaker MS, Gordan VV, Rindal DB, Fellows JL, Gilbert GH; National Dental PBRN Collaborative Group. Cluster Effects in a National Dental PBRN restorative study. J Dent Res. 2013 Sep;92(9):782-7. doi: 10.1177/0022034513497752. Epub 2013 Jul 15.
PubMed 23857643
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reasons for Placing the First Restoration on Permanent Tooth Surfaces
- ClinicalTrials.gov ID
- NCT00847470
- Acronym / sponsor ID
- 101883
- Conditions
- Dental Caries
- Keywords
- Dental caries, Assessments, dental materials
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,810 participants (actual)
- Lead sponsor
- Dental Practice-Based Research NetworkResearch network
- Collaborators
- HealthPartners Institute, Kaiser Permanente, Permanente Dental Associates Group, Oregon, University of Copenhagen, University of Florida, University of North Carolina, Chapel Hill
- Study start
- Jun 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 19 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to document the reasons for placing the first restoration ("filling") on a previously un-restored surface in a permanent ("adult") tooth.
Detailed description
The aims of this study were to (1) quantify DPBRN practitioner-investigators pre-operative and post-operative assessments of the depth of the caries lesion being treated; (2) quantify the prevalence of dental material types used to restore the first restoration in a permanent tooth surface; and (3) test the hypothesis that DPBRN practitioner investigators in the "Assessment of caries diagnosis and caries treatment" study who stated that they wait until the caries lesions reach dentin before they place the first restoration are in fact more likely in this study to do restoration in teeth that have caries reaching into dentin.
The aims were met by enrolling 230 DPBRN practitioner-investigators in the "Reasons for placing the first restoration on permanent tooth surfaces" study, each of whom recorded information about approximately 50 consecutive restorations that they placed on unrestored surfaces. This study about restorative treatment received by patients provided the opportunity to record the variations in the treatment provided, and also provided a basis for subsequent future studies to investigate how defects on fillings develop over time. These results will also be related to the findings from "Assessment of caries diagnosis and caries treatment" study where practitioners outlined how they detected dental decay, the stage at which the decay was treated by placing fillings, and how they rely on preventive measures to stop the decay process without placing fillings.
Study design
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Practitioner investigators must have been enrolled in the DPBRN, completed the "Assessment of caries diagnosis \& caries treatment" study; and do at least some restorative dentistry in their practices. The human subjects directly involved in this study were patients who had sought treatment in the DPBRN practitioners' practices.
Key inclusion criteria (2 listed)
- participants directly involved in this study were patients who sought dental treatment in the practitioner-investigators' practices
- any tooth surface that was previously unrestored was eligible for this study, provided that it was on a permanent ("adult") tooth. This means that permanent first molars were eligible, which typically erupt at about age 6 years. This means that persons age 6 and older were enrolled in the study and there was no upper age limit.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2014.
- Derived from this study: PubMed 23857643Litaker MS, Gordan VV, Rindal DB, Fellows JL, Gilbert GH; National Dental PBRN Collaborative Group. Cluster Effects in a National Dental PBRN restorative study. J Dent Res. 2013 Sep;92(9):782-7. doi: 10.1177/0022034513497752. Epub 2013 Jul 15.
- Dental Practice-Based Research NetworkLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregg H. Gilbert, DDS, MBA study chair
Dental Practice-Based Research Network
Valeria V. Gordan, DDS, MS, MSCI principal investigator
Dental Practice-Based Research Network
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Caries, run by Dental Practice-Based Research Network at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00847470, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2014.