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CompletedNCT00618215Updated Feb 19, 2008

A Cluster Randomized Controlled Trial in Primary Oral Care

An Early Phase 1 interventional study of peer group educational implementation strategy in Tooth, Impacted, sponsored by Radboud University Medical Center. Completed at 1 site in Netherlands. Per ClinicalTrials.gov, last updated 2008-02-19.

Sponsored by Radboud University Medical Center · Early Phase 1, Interventional, and Health services research

Phase
Early Phase 1
Study type
Interventional
Enrollment
1,161
Allocation
Randomized
Sex
All
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Study 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 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.

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Conditions studied

  • Tooth, Impacted

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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
03

In context

Tooth, Impacted

200 studies on the registry are indexed under Tooth, Impacted; 21 are open to participants now.

This study's enrollment of 1,161 is above the median of 56 across 167 interventional studies indexed under Tooth, Impacted.

Browse Tooth, Impacted studies →

Lead sponsor

Radboud University Medical Center is the lead sponsor of 984 studies on the registry; 135 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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.

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

Exclusion criteria

Exclusion Criteria:

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.
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Study design

Phase
Early Phase 1
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Single (Care provider)
Enrollment
1,161 participants (actual)

Study arms

  • Experimental
    I

    ROE Group Interventions:behaviorial

    Behavioral: peer group educational implementation strategy

  • Experimental
    2

    MIM Group Interventions:behaviorial

    Behavioral: peer group educational implementation strategy

Interventions

  • Behavioralpeer group educational implementation strategy

    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

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What researchers measure

Primary outcomes

  1. 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

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.

    Time frame: september 2006 and june 2007

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Study locations

1 site
  • University Medical Centre St Radboud
    Nijmegen, Gelderland 6500 HB, Netherlands
08

References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 19, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00618215
Collaborators
Dutch Health Care Insurance Board, Department of Preventive and Restorative Dentsitry and Centre of Quality of Care Research (WOK)
First posted
Feb 19, 2008
Start date
Sep 2006
Primary completion
Jun 2007
Completion
Jul 2007
Last update
Feb 19, 2008

Study contacts

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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2008. You cannot join it, but the record below documents what was studied.

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