The Monitor Practice Program - is non-invasive management of dental caries in private practice cost-effective?

ISRCTN	ISRCTN67374556
DOI	https://doi.org/10.1186/ISRCTN67374556
Protocol serial number	402466
Sponsor	University of Sydney (Australia)
Funder	National Health and Medical Research Council (NHMRC) (Australia) (ref: 402466)

Submission date: 05/02/2009
Registration date: 30/03/2009
Last edited: 30/03/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Oral Health

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Bradley Curtis
Scientific

University of Sydney
Population Oral Health Research Unit
1 Mons Rd
Westmead
NSW 2145
Australia

Study information

Primary study design	Interventional
Study design	Cluster randomised controlled clinical trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	The cost-effectiveness of non-invasive management of dental caries in private practice: a cluster randomised controlled clinical trial
Study acronym	MPP
Study objectives	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(s)	Sydney University Human Ethics Committee gave approval on the 24th November 2004 (ref: 7810)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	30/09/2012

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	All
Target sample size at registration	800
Key inclusion criteria	1. All patients attending for dental treatment within recruited dental practices 2. Aged 5 years and over, either sex
Key exclusion criteria	Unable to provide informed consent
Date of first enrolment	01/03/2005
Date of final enrolment	30/09/2012

Locations

Countries of recruitment

Australia

Study participating centre

University of Sydney

Westmead
NSW 2145
Australia

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	recruitment results	01/06/2007		Yes	No
Results article	results	01/12/2008		Yes	No
Other publications	patient perspective	01/12/2007		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes