Assessment of Caries Diagnosis and Caries Treatment in Dental PBRN Japan

An observational study of Dental Caries, run by Dental PBRN Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The objective of this study is to examine what methods Dental PBRN Japan dentists adopt for diagnosis, treatment, and prevention of dental caries. Read more about this study

Who is it for?: Ages 24 years and olderHealthy volunteers can take part
Conditions the study is for: Dental Caries
How many people: 282 participants
Where: No sites listed yet
Study dates: May 2010to Feb 2015
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 24 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: Participants are dentists who work in outpatient dental practices who have affiliated with Dental PBRN Japan

Who may be able to join

This study queried dentists working in outpatient dental practices who have affiliated with JDPBRN to investigate research questions and to share experiences and expertise (n = 282).

Who cannot join

Dentist who doesn't perform some measure of restorative dentistry at their practice.

About this study

The objective of this study is to examine what methods Dental PBRN Japan dentists adopt for diagnosis, treatment, and prevention of dental caries.

Read the detailed description

We conducted a cross-sectional study consisting of a questionnaire survey in Japan. We used the same questionnaire as used in the DPBRN Study, "Assessment of Caries Diagnosis and Caries Treatment".

Conditions: Dental Caries
Keywords: Dental caries,, Caries diagnosis,, Caries treatment,, Caries risk,, Practice pattern,, Clinical epidemiology,, Dental Practice-Based Research Network
Medical subject headings: Dental Caries

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants Who Indicate Surgical Intervention
Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2010Feb 2015

First posted7 Sep 2012 (estimated)
Study startMay 2010
Primary completionOct 2012
Study completionFeb 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (6)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: 282 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01680848
Sponsor's protocol ID: E1157
Status last verified: Aug 2016
First submitted: 4 Sep 2012
Last updated: 12 Dec 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No: Currently, we have no plan.

Publications

Yokoyama Y, Kakudate N, Sumida F, Matsumoto Y, Gilbert GH, Gordan VV. Evidence-practice gap for dental sealant application: results from a dental practice-based research network in Japan. Int Dent J. 2016 Dec;66(6):330-336. doi: 10.1111/idj.12252. Epub 2016 Jul 28.
PubMed 27466073
Yokoyama Y, Kakudate N, Sumida F, Matsumoto Y, Gilbert GH, Gordan VV. Evidence-practice gap for in-office fluoride application in a dental practice-based research network. J Public Health Dent. 2016 Mar;76(2):91-7. doi: 10.1111/jphd.12114. Epub 2015 Jul 31.
PubMed 26235360
Kakudate N, Sumida F, Matsumoto Y, Yokoyama Y, Riley JL 3rd, Gilbert GH, Gordan VV. Dentists' decisions to conduct caries risk assessment in a Dental Practice-Based Research Network. Community Dent Oral Epidemiol. 2015 Apr;43(2):128-34. doi: 10.1111/cdoe.12127. Epub 2014 Sep 1.
PubMed 25175077
Kakudate N, Sumida F, Matsumoto Y, Yokoyama Y, Gilbert GH, Gordan VV. Patient age and dentists' decisions about occlusal caries treatment thresholds. Oper Dent. 2014 Sep-Oct;39(5):473-80. doi: 10.2341/13-141-C. Epub 2014 May 8.
PubMed 24809540
Yokoyama Y, Kakudate N, Sumida F, Matsumoto Y, Gilbert GH, Gordan VV. Dentists' dietary perception and practice patterns in a dental practice-based research network. PLoS One. 2013;8(3):e59615. doi: 10.1371/journal.pone.0059615. Epub 2013 Mar 25.
PubMed 23536883
Kakudate N, Sumida F, Matsumoto Y, Manabe K, Yokoyama Y, Gilbert GH, Gordan VV. Restorative treatment thresholds for proximal caries in dental PBRN. J Dent Res. 2012 Dec;91(12):1202-8. doi: 10.1177/0022034512464778. Epub 2012 Oct 9.
PubMed 23053847

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Dental Caries trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessment of Caries Diagnosis and Caries Treatment in Dental PBRN Japan
ClinicalTrials.gov ID: NCT01680848
Acronym / sponsor ID: E1157
Conditions: Dental Caries
Keywords: Dental caries,, Caries diagnosis,, Caries treatment,, Caries risk,, Practice pattern,, Clinical epidemiology,, Dental Practice-Based Research Network
Study type: Observational
Recruitment status: Completed
Enrolment: 282 participants (actual)
Lead sponsor: Dental PBRN JapanResearch network
Collaborators: Dental Practice-Based Research Network
Study start: May 2010
Primary completion: Oct 2012 (actual)
Study completion: Feb 2015 (actual)
First posted: 7 Sep 2012 (estimated)
Results: Posted 12 Dec 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The objective of this study is to examine what methods Dental PBRN Japan dentists adopt for diagnosis, treatment, and prevention of dental caries.

Detailed description

We conducted a cross-sectional study consisting of a questionnaire survey in Japan. We used the same questionnaire as used in the DPBRN Study, "Assessment of Caries Diagnosis and Caries Treatment".

Study design

Observational model: Cohort
Time perspective: Cross-sectional

Who may qualify

Ages: 24 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Participants are dentists who work in outpatient dental practices who have affiliated with Dental PBRN Japan

Key inclusion criteria (1 listed)

This study queried dentists working in outpatient dental practices who have affiliated with JDPBRN to investigate research questions and to share experiences and expertise (n = 282).

Key exclusion criteria (1 listed)

Dentist who doesn't perform some measure of restorative dentistry at their practice.

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

Percentage of Participants Who Indicate Surgical Intervention
Time frame: Up to 24 months

Results and safety

Results posted to the registry on 12 Dec 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
JDPBRN Dentists	282	189

Primary outcome: Percentage of Participants Who Indicate Surgical Intervention

Time frame: Up to 24 months. Number. Unit: percentage of the dentists

Measure	High Caries Risk n = 187
Value	74

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
This is an Observational Study	0 of 0	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27466073Yokoyama Y, Kakudate N, Sumida F, Matsumoto Y, Gilbert GH, Gordan VV. Evidence-practice gap for dental sealant application: results from a dental practice-based research network in Japan. Int Dent J. 2016 Dec;66(6):330-336. doi: 10.1111/idj.12252. Epub 2016 Jul 28.
Derived from this study: PubMed 26235360Yokoyama Y, Kakudate N, Sumida F, Matsumoto Y, Gilbert GH, Gordan VV. Evidence-practice gap for in-office fluoride application in a dental practice-based research network. J Public Health Dent. 2016 Mar;76(2):91-7. doi: 10.1111/jphd.12114. Epub 2015 Jul 31.
Derived from this study: PubMed 25175077Kakudate N, Sumida F, Matsumoto Y, Yokoyama Y, Riley JL 3rd, Gilbert GH, Gordan VV. Dentists' decisions to conduct caries risk assessment in a Dental Practice-Based Research Network. Community Dent Oral Epidemiol. 2015 Apr;43(2):128-34. doi: 10.1111/cdoe.12127. Epub 2014 Sep 1.
Derived from this study: PubMed 24809540Kakudate N, Sumida F, Matsumoto Y, Yokoyama Y, Gilbert GH, Gordan VV. Patient age and dentists' decisions about occlusal caries treatment thresholds. Oper Dent. 2014 Sep-Oct;39(5):473-80. doi: 10.2341/13-141-C. Epub 2014 May 8.
Derived from this study: PubMed 23536883Yokoyama Y, Kakudate N, Sumida F, Matsumoto Y, Gilbert GH, Gordan VV. Dentists' dietary perception and practice patterns in a dental practice-based research network. PLoS One. 2013;8(3):e59615. doi: 10.1371/journal.pone.0059615. Epub 2013 Mar 25.
Derived from this study: PubMed 23053847Kakudate N, Sumida F, Matsumoto Y, Manabe K, Yokoyama Y, Gilbert GH, Gordan VV. Restorative treatment thresholds for proximal caries in dental PBRN. J Dent Res. 2012 Dec;91(12):1202-8. doi: 10.1177/0022034512464778. Epub 2012 Oct 9.
Individual participant dataSharing planned: No. Currently, we have no plan.

Related trials for Dental Caries

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Haemophilia A, Haemophilia B
Not yet recruiting
Clinical and Radiographic Evaluation of Silver Diamine Fluoride Versus Light-Cured Silver Diamine Fluoride in Carious Primary Molars
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Not yet recruiting
Clinical Performance of CAD/CAM Hard Hybrid Ceramic Inlays Versus Resin Composite Inlays in Vital Molars With Extensive Occluso-Proximal Cavities
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Not yet recruiting
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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.

Naoki Kakudate, DDS PhD MPH principal investigator

Kyushu Dental University

Questions about this trial

What is this clinical trial studying?

An observational study of Dental Caries, run by Dental PBRN Japan.

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 1 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 12 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

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?

Yes. Results are posted in the registry (first posted 12 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants Who Indicate Surgical Intervention (time frame: Up to 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 NCT01680848, which also lists 6 linked publications.

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 12 Dec 2016.