Condition category
Oral Health
Date applied
05/02/2009
Date assigned
30/03/2009
Last edited
30/03/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Bradley Curtis

ORCID ID

Contact details

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

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 measures

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

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

http://www.usyd.edu.au/

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

  3. 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.

Additional files

Editorial Notes