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 |
| Secondary identifying numbers | 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
Scientific
University of Sydney
Population Oral Health Research Unit
1 Mons Rd
Westmead
NSW 2145
Australia
Study information
| Study design | Cluster randomised controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Can be found at http://www.dentistry.usyd.edu.au/mpp/downloads.htm |
| 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 | 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 study start date | 01/03/2005 |
| Completion date | 30/09/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Both |
| Target number of participants | 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
NSW 2145
Australia
Sponsor information
University of Sydney (Australia)
University/education
University/education
Population Oral Health Research Unit
1 Mons Rd
Westmead
NSW 2145
Australia
| Website | http://www.usyd.edu.au/ |
|---|---|
"ROR" |
https://ror.org/0384j8v12 |
Funders
Funder type
Research council
National Health and Medical Research Council (NHMRC) (Australia) (ref: 402466)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- NHMRC
- Location
- Australia
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| 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 | |
| Other publications | patient perspective | 01/12/2007 | Yes | No | |
| Results article | results | 01/12/2008 | Yes | No |
