Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
402466
Study information
Scientific title
The cost-effectiveness of non-invasive management of dental caries in private practice: a cluster randomised controlled clinical trial
Acronym
MPP
Study hypothesis
1. That there is a statistically significant difference in the increment of decayed, missing, and filled tooth surfaces (DMFS) between a preventive and a standard care oral health program
2. That management of dental decay using a preventive remineralising approach is more cost-effective than the standard approach which involves filling the tooth
Ethics approval
Sydney University Human Ethics Committee gave approval on the 24th November 2004 (ref: 7810)
Study design
Cluster randomised controlled clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Can be found at http://www.dentistry.usyd.edu.au/mpp/downloads.htm
Condition
Dental caries
Intervention
Control arm:
Usual dental care.
Intervention arm:
The Caries Management System is a ten-step non-invasive strategy to arrest and remineralise early lesions. This system was developed for use by general practitioners according to a new Caries Management Policy that had been adopted by the Faculty of Dentistry, University of Sydney, where learning and teaching within the new curriculum was designed to be informed by evidence-based practice. The governing principle of the Caries Management System is that caries management must include consideration of:
1. The patient at risk
2. The status of each lesion
3. Patient management
4. Clinical management
5. Monitoring
Both dental caries risk and dental caries treatment are managed according to a set of protocols which refer only to those interventions that are well supported by a strong evidence base. The protocols are applied at various steps throughout patient consultation and treatment and have a twin focus on the primary prevention of caries and its secondary prevention (arrest and reversal of early lesions) through non-invasive measures.
Assessment of dental plaque control:
1. Saliva assessment
2. The status of each lesion
Clinical examination:
1. Bite-wing radiographic survey
2. Assessment of the patient's caries risk status
Patient management:
1. Case presentation and treatment planning
2. Diet advice
3. Oral hygiene instruction and coaching
4. Clinical management
5. Monitoring
6. Caries activity
7. Diet control
8. Plaque control
9. Fluoride exposure
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. Reduction in incremental DMFS score
2. Incremental cost-effectiveness ratio
Interim analysis at 2 years (to determine efficacy for the cost-effectiveness analysis), final analysis 3 years.
Secondary outcome measures
1. Patient and dentist acceptability
2. Impediments to implementation
Interim analysis at 2 years (to determine efficacy for the cost-effectiveness analysis), final analysis 3 years.
Overall trial start date
01/03/2005
Overall trial end date
30/09/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. All patients attending for dental treatment within recruited dental practices
2. Aged 5 years and over, either sex
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
800
Participant exclusion criteria
Unable to provide informed consent
Recruitment start date
01/03/2005
Recruitment end date
30/09/2012
Locations
Countries of recruitment
Australia
Trial participating centre
University of Sydney
Westmead
NSW 2145
Australia
Sponsor information
Organisation
University of Sydney (Australia)
Sponsor details
Population Oral Health Research Unit
1 Mons Rd
Westmead
NSW 2145
Australia
Sponsor type
University/education
Website
Funders
Funder type
Research council
Funder name
National Health and Medical Research Council (NHMRC) (Australia) (ref: 402466)
Alternative name(s)
NHMRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Australia
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2007 recruitment results in http://www.ncbi.nlm.nih.gov/pubmed/17687955
2. 2007 patient perspective in http://www.ncbi.nlm.nih.gov/pubmed/18265681
3. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/19133945
Publication citations
-
Recruitment results
Curtis B, Evans RW, Sbaraini A, Schwarz E, Recruitment and standardization of a group of Australian dentists for a multipractice study on dental caries prevention., Aust Dent J, 2007, 52, 2, 106-111.
-
Patient perspective
Curtis B, Evans RW, Sbaraini A, Schwarz E, Geographic location and indirect costs as a barrier to dental treatment: a patient perspective., Aust Dent J, 2007, 52, 4, 271-275.
-
Results
Curtis B, Evans RW, Sbaraini A, Schwarz E, The Monitor Practice Programme: is non-invasive management of dental caries in private practice effective?, Aust Dent J, 2008, 53, 4, 306-313, doi: 10.1111/j.1834-7819.2008.00071.x.