Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000901000
Ethics application status
Approved
Date submitted
27/09/2010
Date registered
25/10/2010
Date last updated
1/11/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Implementing a Minimal Intervention Dentistry Clinical Protocol for adolescent public dental patients at high risk of dental caries: a pilot study.
Scientific title
In adolescent public dental patients at high risk of dental caries, does a minimal intervention dentistry clinical protocol change caries risk assessment when compared to standard care?
Secondary ID [1] 252757 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
MID-APP (Minimal Intervention Dentistry Adolescent Pilot Project)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dental caries 258259 0
Condition category
Condition code
Public Health 258449 258449 0 0
Health service research
Oral and Gastrointestinal 258450 258450 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1 - Control Arm - Standard course of dental care

Arm 2 - Test Arm - will have all four principles of Minimal Intervention Dentistry (MID) approach for the management of dental caries implemented by the community clinic oral health practitioners, namely:
1. prevention and early intervention to control the disease. Patients’ caries risk level will be identified as outlined by Evans et al (2008) and a treatment plan based on the caries risk assessment will be developed and implemented. A dental therapist will undertake motivational interviews with the patients to promote self management of dental caries including oral hygiene instruction, dietary habits, the importance of saliva, the role of fluoride and antibacterial therapies.
2. Remineralisation and ongoing monitoring of non-cavitated active lesions including preventive and re-mineralization procedures, application of fluoride varnish and bioavailable calcium phosphate agents, and application of fissure sealants. In addition, patients will be provided with oral health care products for home care as required.
3. Any carious lesion becoming cavitated or progressing into the outer third of the dentine (based on the bitewing radiographs) will be restored by the dental therapist/s employed by the community dental clinic using adhesive and biomimetic restorative materials according to the protocol for the management of carious lesions devised by Jenson et al (2008).
4. Where appropriate, failed restorations will be repaired rather than being replaced by the dental therapists/s employed by the community dental clinic with the use of minimal cavity designs and adhesive and biomimetic restorative materials.
The overall duration of the intervention is 12 months with review appointments at 3 months, 6 months and 12 months.
Intervention code [1] 257284 0
Prevention
Intervention code [2] 257397 0
Treatment: Other
Comparator / control treatment
Patients identified to be at risk to dental careis are examined, provided with dental treatment as required and are reviewed every 12 months as the standard course of dental care.
Control group
Active

Outcomes
Primary outcome [1] 259296 0
Primary Outcome 1: Change in caries risk assessment. A Caries Risk Assessment tool based on the literature has been developed for this project which include disease indicators, biological predisposing factors and protective factors. Three caries management by risk assessment catagories have been identified: 1. Low risk, moderate risk and high risk.
Timepoint [1] 259296 0
Timepoint: at baseline, 3, 6 and 12 months after intervention commencement.
Secondary outcome [1] 265723 0
Secondary outcome: identify barriers within a community dental setting to the implementation of an MID clinical protocol for the magagement of adolescent public dental patients at high risk to dental caries. The assessment will include semi-structured interviews with the clinicians involved in the MID-APP Pilot Project at the completion of the project in 12 months.
Timepoint [1] 265723 0
Timepoint: at 12 months after intervention commencement.

Eligibility
Key inclusion criteria
Inclusion criteria for this study include:
1. Adolescent patients (13-18 years) who hold a concession card or are dependents of a concession card holder.
2. Adolescent patients assessed as being at high risk to developing dental caries.
3. Adolescent patients attending 12-month high-risk recall visit at the Western Region Health Centre Dental clinic.
Minimum age
13 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria for this study include:
1. Methamphetamine users and drug addicted patients
2. Patients with severe salivary gland hypofunction
3. Patients with medical or physical conditions that may, in the opinion of the investigators, compromise the study outcome e.g. requiring anticoagulant therapy; diagnosed intellectual, physical or mental health disability; conditions requiring chemotherapy or radiotherapy.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
After assessing the eligibility of the participants, obtaining consent and collecting baseline data, subjects will be randomly allocated to treatment groups. Treatment allocation will be concealed with treatments being assigned by opening sequentially numbered opaque envelopes. The treating dentist will be required to sign and date the randomization log as each envelop is opened.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer generated block randomization schedule using random blocks. The random allocation sequence will be contained within opaque envelopes with numerical sequencing corresponding to the order in which subjects are recruited into the trial.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257721 0
Government body
Name [1] 257721 0
Dental Health Services Victoria
Country [1] 257721 0
Australia
Primary sponsor type
Government body
Name
Dental Health Services Victoria
Address
Corporate Office
GPO 1273L Melbourne
Melbourne VIC 3001

720 Swanston Street
Carlton VIC 3053
VIC
Country
Australia
Secondary sponsor category [1] 256937 0
University
Name [1] 256937 0
The University of Melbourne, Melbourne Dental School
Address [1] 256937 0
720 Swanston Street
Carlton VIC 3053
Country [1] 256937 0
Australia
Secondary sponsor category [2] 257038 0
Commercial sector/Industry
Name [2] 257038 0
Colgate-Palmolive Ltd.,
Address [2] 257038 0
Level 4
345 Geroge Street Sydney
NSW 2000
Country [2] 257038 0
Australia
Other collaborator category [1] 251531 0
Commercial sector/Industry
Name [1] 251531 0
GC Asia Dental PTE Ltd
Address [1] 251531 0
Changi International Logistics Centre
19 Loyang Way, #06-27
508724
Country [1] 251531 0
Singapore

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259769 0
Dental Health Services Victoria Human Research Ethics Committee.
Ethics committee address [1] 259769 0
Corporate Office
GPO 1273L
Melbourne VIC 3001

720 Swanston Street
Carlton VIC 3053
Ethics committee country [1] 259769 0
Australia
Date submitted for ethics approval [1] 259769 0
Approval date [1] 259769 0
21/09/2010
Ethics approval number [1] 259769 0
219

Summary
Brief summary
Dental caries (tooth decay) is the second most costly diet-related disease in Australia. Its economic impact is comparable with that of heart disease and diabetes with an increasing total expenditure for dental services from $4.4 billion per annum (6.1 % of total health expenditure) in 2001 to more than $5.3 billion per annum (10% of total health expenditure across Australia) in 2007. Research has demonstrated that placing dental fillings does nothing to manage the dental caries disease process. Minimal Intervention Dentistry (MID) is a multi-pronged approach which focuses on the management of dental caries as a diet related, transmissible, infectious disease. It comprises measures that range from prevention, early intervention, and treatment. The proposed research will be undertaken with a group of adolescent public dental patients (concession-card holders). The current direct-service delivery model does not place specific emphasis on the management of dental caries through caries risk assessment, prevention or early intervention. The overall goal of this project is to undertake a pilot study to test the impact on caries-risk status of implementing a MID clinical protocol to a group of adolescent public dental patients (aged 13-18 years) who are at high risk to dental caries.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31690 0
Address 31690 0
Country 31690 0
Phone 31690 0
Fax 31690 0
Email 31690 0
Contact person for public queries
Name 14937 0
Su-yan Barrow
Address 14937 0
Dental Health Services Victoria
GPO Box 1273L
Melbourne VIC 3001

720 Swanston Street
Carlton VIC 3053
Country 14937 0
Australia
Phone 14937 0
+61 3 9341 1393
Fax 14937 0
+61 3 9341 1234
Email 14937 0
suyan.barrow@dhsv.org.au
Contact person for scientific queries
Name 5865 0
Dr. Hanny Calache
Address 5865 0
Dental Health Services Victoria
GPO Box 1273L
Melbourne VIC 3001

720 Swanston Street
Carlton VIC 3053
Country 5865 0
Australia
Phone 5865 0
+61 3 9341 1291
Fax 5865 0
+61 3 9341 1234
Email 5865 0
hanny.calache@dhsv.org.au

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No Supporting Document Provided



Results publications and other study-related documents

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