Dental CariesNCT01201876
DPBRN Reasons for Replacement or Repair of Dental Restorations
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 replacement or repair of defective restorations ("fillings") and to record the restorative material of the failed restoration and the material used in the replacement restoration on permanent ("adult") teeth. 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
- 6,368 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Nov 2008to Mar 2010
- 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 dental treatment in the DPBRN practitoners' 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 restored 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, 35294-0007
University of Florida College of Dentistry
Gainesville, Florida, 32610
Health Partners Dental Group
Minneapolis, Minnesota, 55440-1309
Health Partners Research Foundation
Minneapolis, Minnesota, 55440-1524
Kaiser Permanente Center for Health Research
Portland, Oregon, 97227
Permanente Denrtal Associates
Portland, Oregon, 97232
About this study
Official title: Reasons for Replacement or Repair of Dental Restorations
The purpose of this study was to document the reasons for replacement or repair of defective restorations ("fillings") and to record the restorative material of the failed restoration and the material used in the replacement restoration on permanent ("adult") teeth.
Read the detailed description
The aims of this study were to (1) quantify the prevalence of reason(s) for replacing existing restorations in DPBRN practices; (2) quantify the percentages and types of restorative materials of failed restorations that are being replaced in DPBRN practices; (3) quantify the percentages and types of restorative materials used to replace or repair failed restorations in DPBRN practices; and (4) test the hypothesis that DPBRN practitioner-investigators who reported in a previous study that they treat enamel lesions operatively are more likely in actual patients as in this study to replace entire restorations rather than do repairs and are more likely to report the clinical diagnosis of secondary caries as a reason for replacement.
- 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 posted15 Sep 2010 (estimated)
- Study startNov 2008
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 6,368 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dental Practice-Based Research Network
- Sponsor type
- Research network
- Collaborators
- HealthPartners Institute, Heatlh Partners Research Foundation (Minnesota), Kaiser Permanente, Permanente Dental Associates Group, Oregon, National Institute of Dental and Craniofacial Research (NIDCR)
- Investigators
- Valeria V Gordan, DDS, MS, MSCI, Principal investigator, Dental Practice-Based Research NetworkGregg H Gilbert, DDS, MBA, Study chair, Dental Practice-Based Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01201876
- Sponsor's protocol ID
- 118680
- Other IDs
- U01DE016747
- Status last verified
- Jun 2011
- First submitted
- 13 Sep 2010
- Last updated
- 16 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reasons for Replacement or Repair of Dental Restorations
- ClinicalTrials.gov ID
- NCT01201876
- Acronym / sponsor ID
- 118680
- Conditions
- Dental Caries
- Keywords
- Dental Caries, Assessments, dental materials
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,368 participants (actual)
- Lead sponsor
- Dental Practice-Based Research NetworkResearch network
- Collaborators
- HealthPartners Institute, Heatlh Partners Research Foundation (Minnesota), Kaiser Permanente, Permanente Dental Associates Group, Oregon, National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- Nov 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 15 Sep 2010 (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 replacement or repair of defective restorations ("fillings") and to record the restorative material of the failed restoration and the material used in the replacement restoration on permanent ("adult") teeth.
Detailed description
The aims of this study were to (1) quantify the prevalence of reason(s) for replacing existing restorations in DPBRN practices; (2) quantify the percentages and types of restorative materials of failed restorations that are being replaced in DPBRN practices; (3) quantify the percentages and types of restorative materials used to replace or repair failed restorations in DPBRN practices; and (4) test the hypothesis that DPBRN practitioner-investigators who reported in a previous study that they treat enamel lesions operatively are more likely in actual patients as in this study to replace entire restorations rather than do repairs and are more likely to report the clinical diagnosis of secondary caries as a reason for replacement.
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 dental treatment in the DPBRN practitoners' 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 restored 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 16 Jun 2011.
- 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.
Valeria V Gordan, DDS, MS, MSCI principal investigator
Dental Practice-Based Research Network
Gregg H Gilbert, DDS, MBA study chair
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 16 Jun 2011. 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?
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 16 Jun 2011.