Tooth, ImpactedEarly Phase 1NCT00618215
A Cluster Randomized Controlled Trial in Primary Oral Care
A Early Phase 1 study testing peer group educational implementation strategy in people with Tooth, Impacted, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Background: Routine oral examination (ROE) refers to periodic monitoring of the general and oral health status of patients. In most developed Western countries a decreasing prevalence of oral diseases underpins the need for a more individualised approach in assigning recall intervals for regular attendees instead of… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tooth, Impacted
- What is being tested?
- peer group educational implementation strategy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,161 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2006to Jul 2007
- Phase
- Early Phase 1
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- GDPs inclusion criteria
- GDPs have to work in general dental practice for at least three days/week and should have practice experience for at least three years. They were eligible if their practice population was characterised by primary oral care patients, consisting of regular attendees, and patient recordkeeping was conducted electronically. GDPs had to give their informed consent to assess and evaluate electronically patient records. Patient data were collected anonymously.
- Patient's inclusion criteria
- To be eligible for inclusion, patients should meet (fulfil) several criteria, depending on the IQual's CPG to be used (ROE or MIM):
- ROE:
- All patients regularly visiting their dentist (at least once a year) over the past three years for ROEs will be included in the study.
Show all 9Show fewer
- MIM:
- All patients regularly visiting their dentist (at least once a year) over the past three years for ROEs are included for the study and, in addition, have to be aged between 17 and 35 years, with disease-free impacted mandibular third molars in retention.
- For both group of patients, it is important that they can be linked particular to the participating GDP, especially in practices with more than one GDP occupied
Who cannot join
- Patient's exclusion criteria
- ROE:
- Patients with symptomatic driven (emergency) attendance in dental practice, or recently started regular attendance in the participating dental practice (within past three years).
- MIM:
- Patients with symptomatic third molars in dental practice, or recently started regular attendance (past three years) or who already had their third molars removed.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
University Medical Centre St Radboud
Nijmegen, Gelderland, 6500 HB
About this study
Official title: Impact of Multifaceted Peer Group Education to Improve Routine Oral Examinations in Primary Care A Cluster-Randomised Controlled Trial
Background: Routine oral examination (ROE) refers to periodic monitoring of the general and oral health status of patients. In most developed Western countries a decreasing prevalence of oral diseases underpins the need for a more individualised approach in assigning recall intervals for regular attendees instead of systematic decision making of fixed intervals. From a quality of care perspective as well, one can also question the effectiveness of the widespread prophylactic removal of mandibular impacted asymptomatic third molars (MIM) in adolescents and adults. It is as yet unclear how quality of oral care can be improved. Research data on effectiveness of interventions to promote continuing professional development for dentists are rare.
Methods/Design: This implementation study is a cluster randomised controlled trial with groups of GDPs as the unit of randomisation. The aim of the study is to determine the effectiveness and efficiency of small group quality improvement on professional decision making of general dental practitioners (GDPs) in daily practice. Six peer groups ('IQual-groups') shall be randomised either to the intervention group I or group II. Groups of GDPs allocated to either of these arms act as each other's control group. An IQual peer group consists of 8-10 GDPs who attend in monthly structured sessions scheduled for discussion on practice related topics.
Read more
GDPs in both trail arms receive recent developed evidence-based CPG on ROE or MIM respectively. The implementation strategy consists of 1 interactive IQual circle meeting of mostly 2-3 hours. In addition, both groups of GDPs receive feedback on personal and group characteristics and are invited to make use of web-based patient vignettes for further individual training on risk assessment policy. A few weeks after the interactive meeting reminders (flow charts) will be send by mail.
The main outcome measure for the ROE-study and control group is the use and appropriateness of individualised risk assessment in assigning recall intervals and for the MIM-study the use and appropriateness of individualised mandibular impacted third molar risk management.
Measurements (pre-intervention data collection) will take place in months 1-3, starting in September 2006. Post-intervention data collection will be performed after 9 months.
Discussion: In most developed Western countries a decreasing prevalence of oral diseases underpins the need for a more individualised approach in assigning recall intervals for regular attendees. If the evaluation of this multifaceted implementation study reveals a shift in individual performance of GDPs in assessing risks for oral disease, further research questions and efforts to a risk-based professional education could be promoted.
Scientific hypothesis Multifaceted implementation of consensus based clinical practice guidelines (CPGs) for GDPs on ROEs and the management of asymptomatic impacted third molars (MIM) in daily dental practice is more effective and efficient compared to only dissemination of CPGs.
- Conditions
- Tooth, Impacted
- Being tested
- peer group educational implementation strategy
- Keywords
- cluster-randomised trial, routine oral examination, implementation research, practice based research, CPG, recall interval assignment for routine oral examination, prescription bitewing radiographs, preventive advice and feed back oral disease
- Medical subject headings
- Tooth, Impacted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peer group educational implementation strategyBehavioural
Delivery CPG
Education session IQual group
Online training website (individual feed back)
Reminder (flow chart), individual feed back record form
Feed back by email
Registration in practice
| Study group | Role | What they receive |
|---|---|---|
| I | Experimental | ROE Group
Interventions:behaviorial Receives: Behavioral: peer group educational implementation strategy |
| 2 | Experimental | MIM Group
Interventions:behaviorial Receives: Behavioral: peer group educational implementation strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients per GDP with assigned recall interval (months) based on individual recall assessment. For high risk children and adolescents <7 months, in case of low risk > 7 months. For adults 9 months or more for low risk profiles, and ≤ than 9 mo
Measured: September 2006 and June 2007
Secondary outcomes (1)
Number of patients per GDP with prescribed individual frequency of BWs (months). For high-risk children and adolescents <24 months frequency, in low risk profiles >36 months. For high-risk adults < 36 months frequency versus low risk >48 months.
Measured: september 2006 and june 2007
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2008 (estimated)
- Study startSep 2006
- Primary completionJun 2007
- Study completionJul 2007
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 Tooth, ImpactedStudies 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 1,161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Health Care Insurance Board, Department of Preventive and Restorative Dentsitry and Centre of Quality of Care Research (WOK)
- Investigators
- Alphons Plasschaert, Prof Phd, Principal investigator, University Medical Centre St Radboud Nijmegen The Netherlandsdirk Mettes, DMD, Study chair, UMC St Radboud Medical Centre Nijmegen The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00618215
- Sponsor's protocol ID
- CVZ-538/001/2001/RL000003
- Status last verified
- Feb 2008
- First submitted
- 5 Feb 2008
- Last updated
- 19 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Mettes TG, van der Sanden WJ, Wensing M, Grol RP, Plasschaert AJ. A cluster randomised controlled trial in primary dental care based intervention to improve professional performance on routine oral examinations and the management of asymptomatic impacted third molars: study protocol. Implement Sci. 2007 Apr 20;2:12. doi: 10.1186/1748-5908-2-12.
PubMed 17448224
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Multifaceted Peer Group Education to Improve Routine Oral Examinations in Primary Care A Cluster-Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT00618215
- Acronym / sponsor ID
- CVZ-538/001/2001/RL000003
- Conditions
- Tooth, Impacted
- Keywords
- cluster-randomised trial, routine oral examination, implementation research, practice based research, CPG, recall interval assignment for routine oral examination, prescription bitewing radiographs, preventive advice and feed back oral disease
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,161 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Dutch Health Care Insurance Board, Department of Preventive and Restorative Dentsitry and Centre of Quality of Care Research (WOK)
- Study start
- Sep 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 19 Feb 2008 (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.
Background: Routine oral examination (ROE) refers to periodic monitoring of the general and oral health status of patients. In most developed Western countries a decreasing prevalence of oral diseases underpins the need for a more individualised approach in assigning recall intervals for regular attendees instead of systematic decision making of fixed intervals. From a quality of care perspective as well, one can also question the effectiveness of the widespread prophylactic removal of mandibular impacted asymptomatic third molars (MIM) in adolescents and adults. It is as yet unclear how quality of oral care can be improved. Research data on effectiveness of interventions to promote continuing professional development for dentists are rare.
Methods/Design: This implementation study is a cluster randomised controlled trial with groups of GDPs as the unit of randomisation. The aim of the study is to determine the effectiveness and efficiency of small group quality improvement on professional decision making of general dental practitioners (GDPs) in daily practice. Six peer groups ('IQual-groups') shall be randomised either to the intervention group I or group II. Groups of GDPs allocated to either of these arms act as each other's control group. An IQual peer group consists of 8-10 GDPs who attend in monthly structured sessions scheduled for discussion on practice related topics.
GDPs in both trail arms receive recent developed evidence-based CPG on ROE or MIM respectively. The implementation strategy consists of 1 interactive IQual circle meeting of mostly 2-3 hours. In addition, both groups of GDPs receive feedback on personal and group characteristics and are invited to make use of web-based patient vignettes for further individual training on risk assessment policy. A few weeks after the interactive meeting reminders (flow charts) will be send by mail.
The main outcome measure for the ROE-study and control group is the use and appropriateness of individualised risk assessment in assigning recall intervals and for the MIM-study the use and appropriateness of individualised mandibular impacted third molar risk management.
Measurements (pre-intervention data collection) will take place in months 1-3, starting in September 2006. Post-intervention data collection will be performed after 9 months.
Discussion: In most developed Western countries a decreasing prevalence of oral diseases underpins the need for a more individualised approach in assigning recall intervals for regular attendees. If the evaluation of this multifaceted implementation study reveals a shift in individual performance of GDPs in assessing risks for oral disease, further research questions and efforts to a risk-based professional education could be promoted.
Scientific hypothesis Multifaceted implementation of consensus based clinical practice guidelines (CPGs) for GDPs on ROEs and the management of asymptomatic impacted third molars (MIM) in daily dental practice is more effective and efficient compared to only dissemination of CPGs.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I | Experimental | Behavioral: peer group educational implementation strategyROE Group Interventions:behaviorial |
| 2 | Experimental | Behavioral: peer group educational implementation strategyMIM Group Interventions:behaviorial |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- GDPs inclusion criteria
- GDPs have to work in general dental practice for at least three days/week and should have practice experience for at least three years. They were eligible if their practice population was characterised by primary oral care patients, consisting of regular attendees, and patient recordkeeping was conducted electronically. GDPs had to give their informed consent to assess and evaluate electronically patient records. Patient data were collected anonymously.
- Patient's inclusion criteria
- To be eligible for inclusion, patients should meet (fulfil) several criteria, depending on the IQual's CPG to be used (ROE or MIM):
- All patients regularly visiting their dentist (at least once a year) over the past three years for ROEs will be included in the study.
Key exclusion criteria (5 listed)
- Patient's exclusion criteria
- Patients with symptomatic driven (emergency) attendance in dental practice, or recently started regular attendance in the participating dental practice (within past three years).
- Patients with symptomatic third molars in dental practice, or recently started regular attendance (past three years) or who already had their third molars removed.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| peer group educational implementation strategyDelivery CPG Education session IQual group Online training website (individual feed back) Reminder (flow chart), individual feed back record form Feed back by email Registration in practice | Behavioural | 2, I |
Primary outcome
Number of patients per GDP with assigned recall interval (months) based on individual recall assessment. For high risk children and adolescents <7 months, in case of low risk > 7 months. For adults 9 months or more for low risk profiles, and ≤ than 9 mo
Time frame: September 2006 and June 2007
1 secondary outcome
Number of patients per GDP with prescribed individual frequency of BWs (months). For high-risk children and adolescents <24 months frequency, in low risk profiles >36 months. For high-risk adults < 36 months frequency versus low risk >48 months.
Time frame: september 2006 and june 2007
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 2008.
- Background: PubMed 17448224Mettes TG, van der Sanden WJ, Wensing M, Grol RP, Plasschaert AJ. A cluster randomised controlled trial in primary dental care based intervention to improve professional performance on routine oral examinations and the management of asymptomatic impacted third molars: study protocol. Implement Sci. 2007 Apr 20;2:12. doi: 10.1186/1748-5908-2-12.
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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.
Alphons Plasschaert, Prof Phd principal investigator
University Medical Centre St Radboud Nijmegen The Netherlands
dirk Mettes, DMD study chair
UMC St Radboud Medical Centre Nijmegen The Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing peer group educational implementation strategy in people with Tooth, Impacted, run by Radboud University Medical Center at 1 site in Netherlands.
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 9 inclusion and 5 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 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Number of patients per GDP with assigned recall interval (months) based on individual recall assessment. For high risk children and adolescents <7 months, in case of low risk > 7 months. For adults 9 months or more for low risk profiles, and ≤ than 9 mo (time frame: September 2006 and June 2007). 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 NCT00618215, 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 2008.