Dental CariesNCT01309971
DPBRN Longitudinal Study of Questionable Occlusal Caries Lesions
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 will allow us to observe and follow the subjects' treatment from DPBRN Prevalence of Questionable Occlusal Caries Lesions Study over a 24 month period. 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
- 2,624 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Aug 2008to Dec 2011
- 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: The participants directly involved in this study were the patients who have sought dental treatment in the DPBRN practitioner-investigators' practices.
Who may be able to join
- 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.
Who cannot join
- patients under 6 years old
- patients 6 years old and older who do not have a questionable lesion
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: Longitudinal Study of Questionable Occlusal Caries Lesions
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.
Read the 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.
- Conditions
- Dental Caries
- Keywords
- Assessment, Questionable Caries
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Questionable occlusal lesions | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionable Caries
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2011 (estimated)
- Study startAug 2008
- Primary completionMar 2010
- Study completionDec 2011
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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 2,624 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, National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Sponsor
- Investigators
- Sonia K Makhija, DDS, MPH, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01309971
- Sponsor's protocol ID
- 122012
- Other IDs
- U01DE016747
- Status last verified
- Feb 2014
- First submitted
- 4 Mar 2011
- Last updated
- 19 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Makhija SK, Gilbert GH, Funkhouser E, Bader JD, Gordan VV, Rindal DB, Qvist V, Norrisgaard P; National Dental PBRN Collaborative Group. Twenty-month follow-up of occlusal caries lesions deemed questionable at baseline: findings from the National Dental Practice-Based Research Network. J Am Dent Assoc. 2014 Nov;145(11):1112-8. doi: 10.14219/jada.2014.82.
PubMed 25359642
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Study of Questionable Occlusal Caries Lesions
- ClinicalTrials.gov ID
- NCT01309971
- Acronym / sponsor ID
- 122012
- Conditions
- Dental Caries
- Keywords
- Assessment, Questionable Caries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,624 participants (actual)
- Lead sponsor
- Dental Practice-Based Research NetworkResearch network
- Collaborators
- HealthPartners Institute, Kaiser Permanente, Permanente Dental Associates Group, Oregon, National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- Aug 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 7 Mar 2011 (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 will allow us to observe and follow the subjects' treatment from DPBRN Prevalence of Questionable Occlusal Caries Lesions Study over a 24 month period.
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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Questionable occlusal lesions | – | – |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The participants directly involved in this study were the patients who have sought dental treatment in the DPBRN practitioner-investigators' practices.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- patients under 6 years old
- patients 6 years old and older who do not have a questionable lesion
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
Questionable Caries
Time frame: 24 months
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 19 Feb 2014.
- Derived from this study: PubMed 25359642Makhija SK, Gilbert GH, Funkhouser E, Bader JD, Gordan VV, Rindal DB, Qvist V, Norrisgaard P; National Dental PBRN Collaborative Group. Twenty-month follow-up of occlusal caries lesions deemed questionable at baseline: findings from the National Dental Practice-Based Research Network. J Am Dent Assoc. 2014 Nov;145(11):1112-8. doi: 10.14219/jada.2014.82.
- 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.
Sonia K Makhija, DDS, MPH principal investigator
University of Alabama at Birmingham
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 1 inclusion and 2 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 19 Feb 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.
What does the primary outcome measure?
Questionable Caries (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01309971, 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 19 Feb 2014.