search
Back to results

A Cluster Randomized Controlled Trial in Primary Oral Care

Primary Purpose

Tooth, Impacted

Status
Completed
Phase
Early Phase 1
Locations
Netherlands
Study Type
Interventional
Intervention
peer group educational implementation strategy
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Tooth, Impacted focused on measuring 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

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

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.

Sites / Locations

  • University Medical Centre St Radboud

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

I

2

Arm Description

ROE Group Interventions:behaviorial

MIM Group Interventions:behaviorial

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
February 5, 2008
Last Updated
February 18, 2008
Sponsor
Radboud University Medical Center
Collaborators
The health Care Insurance Board (CVZ), Department of Preventive and Restorative Dentsitry and Centre of Quality of Care Research (WOK)
search

1. Study Identification

Unique Protocol Identification Number
NCT00618215
Brief Title
A Cluster Randomized Controlled Trial in Primary Oral Care
Official Title
Impact of Multifaceted Peer Group Education to Improve Routine Oral Examinations in Primary Care A Cluster-Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Radboud University Medical Center
Collaborators
The health Care Insurance Board (CVZ), Department of Preventive and Restorative Dentsitry and Centre of Quality of Care Research (WOK)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Early Phase 1
Interventional Study Model
Factorial Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
1161 (Actual)

8. Arms, Groups, and Interventions

Arm Title
I
Arm Type
Experimental
Arm Description
ROE Group Interventions:behaviorial
Arm Title
2
Arm Type
Experimental
Arm Description
MIM Group Interventions:behaviorial
Intervention Type
Behavioral
Intervention Name(s)
peer group educational implementation strategy
Intervention Description
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
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alphons Plasschaert, Prof Phd
Organizational Affiliation
University Medical Centre St Radboud Nijmegen The Netherlands
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
dirk Mettes, DMD
Organizational Affiliation
UMC St Radboud Medical Centre Nijmegen The Netherlands
Official's Role
Study Chair
Facility Information:
Facility Name
University Medical Centre St Radboud
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6500 HB
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
17448224
Citation
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.
Results Reference
background

Learn more about this trial

A Cluster Randomized Controlled Trial in Primary Oral Care

We'll reach out to this number within 24 hrs