Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001237875
Ethics application status
Approved
Date submitted
13/11/2012
Date registered
22/11/2012
Date last updated
23/11/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing the cost effectiveness of a preventive dental intervention in public dental clinics.
Scientific title
Undertake a clinical trial that would demonstrate that the implementation of a Minimal Intervention Dentistry approach to a group of community dental patients (adolescents aged 11-14 years) who are at high risk to dental caries is likely to be 'cost-effective' compared to 'current practice' in achieving positive oral health outcomes for this population group.
Secondary ID [1] 281535 0
Pilot Study Registration ID:ACTRN12610000901000
Universal Trial Number (UTN)
Trial acronym
ACE MID Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dental Caries 287783 0
Condition category
Condition code
Oral and Gastrointestinal 288134 288134 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Public Health 288192 288192 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Adolescents recruited to the intervention arm will receive the preventive strategies of Minimal Intervention Dentistry during the 2 year study at following timpoints: baseline, 3 months, 6 months, 12 months, 18 months and 24 months.

At the baseline, 12 and 24 month examination appointments, all study participants will complete the Child Health Utility-9D questionnaire and a self-administered questionnaire developed for the study. The questions relate to the participant's knowledge of oral health, oral hygiene behaviour and snacks and beverages consumed. This will be followed by a 45-60 minute examination by an oral health examiner who will also develop a treatment plan. Participants in the test group only, will then visit the Dental Assistant (Certificate IV in Oral Health Promotion) who will provide the following preventive strategies:
1.Based on the examiner’s treatment plan and participant information obtained from participant’s responses to the questionnaire, the Dental Assistant (Certificate IV in Oral Health Promotion) will develop a new homecare plan which will outline agreed goals with respect to diet modification, oral hygiene practice including demonstration of tooth brushing, flossing techniques and if indicated the application of tooth mousse. The participant will receive a copy of their Homecare Plan.
2.Saliva testing ( At baseline and 24 months only)
a.If low stimulated saliva rate– tooth mousse will be provided with 5000ppm fluoride toothpaste
b.If normal stimulated saliva rate - 5000ppm fluoride toothpaste will be recommended with instructions that it should not be used on children younger than 10 years of age
3.Oral hygiene instructions will be given to the participant and where required, issue a disclosing tablet to educate the participant about the presence of plaque
4. Diet counseling
5. Fluoride varnish (2.26% NaF varnish) will be applied to all teeth and issue an oral care pack consisting of oral health promotion resources, 5000 ppm toothpaste, toothbrush, floss and , if indicated, Tooth Mousse.
At the 3, 6 and 18 month review appointments the Dental Assistant (Certificate IV in Oral Health Promotion) will i.Review the homecare plan to assess a change in participant’s oral health habits and diet. The participant will receive a copy of their revised homecare plan.
ii.provide diet assessment, education, oral hygiene instructions including demonstration of tooth brushing and flossing techniques and where required, issue a disclosing tablet to educate participant about the presence of plaque using the Turesky Score apply Fluoride Varnish (2.26% NaF varnish) to all teeth and issue an oral care pack. The duration of each visit with the Dental Assistant (Certificate IV in Oral Health Promotion) will be approximately 45-60 minutes.
Intervention code [1] 286031 0
Prevention
Intervention code [2] 286032 0
Early detection / Screening
Intervention code [3] 286033 0
Behaviour
Comparator / control treatment
Adolescents receiving current standard care for management of carious lesions in community dental clinics. As per the community dental clinic protocol, using the American Academy of Pediatric Dentistry (AAPD) Caries-Risk Assessment Tool for Children, all children and adolescents attending community dental clinics are routinely assessed for their risk to developing dental caries. Patients are categorised as ‘high’, ‘moderate’ or ‘low’ risk as assessed against the clinical, environmental and general health indicators. Those assessed as ‘high risk’ to dental caries are placed on a 12 month recall appointment, Standard clinical care at 12 month recall appointment requires a re-evaluation of the child’s caries-risk status children using information collected from undertaking the following diagnostic and clinical measures: ICDAS II, Plaque Index, Bleeding Index and Calculus Assessment, bitewing x-rays and restorations of newly developed carious lesions.
Control group
Active

Outcomes
Primary outcome [1] 288333 0
A reduction in the number of new and progressing smooth surface carious lesions in the intervention arm, using the following measure, the ICDAS II.
Timepoint [1] 288333 0
Baseline, 12 and 24 month recall
Secondary outcome [1] 299891 0
A reduction in Plaque Index score and Bleeding Index Score. The plaque index score and bleeding index score will form part of the examination. These are indicative of changes in oral hygiene behaviour.
Timepoint [1] 299891 0
Baseline, 12 and 24 month recall
Secondary outcome [2] 300044 0
Secondary Outcome 2.
Salivary flow rates (test participants only). A GC saliva kit will be used to measure the stimulated saliva flow rates.
Timepoint [2] 300044 0
Baseline and 24 month recall
Secondary outcome [3] 300045 0
Participant's oral health knowledge, attitudes and health behaviours and diet related behaviour. Participants will complete a self-administered questionnaire developed for the study and the Child Health Utility-9D tool.
Timepoint [3] 300045 0
Baseline, 12 and 24 month recall
Secondary outcome [4] 300046 0
Socio-economic data relating to parent/carer. Parent's oral health knowledge, attitudes and health behaviours including factors influencing their health behaviours such as cost and access to healthy foods and oral health services and cost of oral care products. Parents/carers will complete a self-administered questionnaire developed for the study.
Timepoint [4] 300046 0
Baseline, 12 and 24 month recall
Secondary outcome [5] 300047 0
Identification of possible barriers to uptake of preventive oral health behaviours and diet changes. A random sample of test participants and their carers from each of the participating agencies allocated to the intervention arm, invited to attend a focus group.
Timepoint [5] 300047 0
Post Study at 24 months
Secondary outcome [6] 300048 0
Secondary Outcome 6
Identification of barriers and enablers amongst participating community dental clinics, to the implementation of an MID approach in community dental clinics. Study examiners, Dental Assitants ( with Cert IV in Oral Health Promotion), agency administration staff, program managers and clinicians will complete a non-validated written questionaire.
Timepoint [6] 300048 0
Post study at 24 months
Secondary outcome [7] 300049 0
Canvas the knowledge, attitude, acceptance and practice with respect to the Minimal Intervention Dentistry approach, among oral health practitioners employed at the participating community dental clinics. Clinicians will complete a self-adminstered questionnaire.
Timepoint [7] 300049 0
Baseline
Secondary outcome [8] 300050 0
Undertake an economic appraisal to asess whether Minimal Intervention Dentistry is likely to be 'value for money' and so how best to implement it from an efficiency perspective. Participating community dental clinics will complete a self administered questionnaire to appraise procedures and resources currently allocated to patient recall. The tool will also provide a profile of allocation and structure of oral health workforce in the participating community dental clinics.
Timepoint [8] 300050 0
Baseline and post study at 24 months

Eligibility
Key inclusion criteria
Adolescent patients aged 11 -14 years who:
1.are holders of or dependents of a Health Care Card or Concession Card AND
2.attend their 12 months high-risk recall visit and completed their general course of care AND
3.are assessed as having developed more than one carious lesion in the last 12 months (including white spot lesions) AND
4.have had all occlusal fissures of premolars,molars and partially erupting molars sealed
Minimum age
11 Years
Maximum age
14 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria for this study include:
methamphetamine users and drug addicted patients

patients with diagnosed medical conditions that may, in the opinion of the investigators, compromise the study outcome

e.g. requiring anticoagulant therapy, chemotherapy or radiotherapy, congenital heart disease.

patients with a diagnosed intellectual or mental health condition which may impair the patient’s comprehension of the MID protocol instructions and their capacity to meet Study requirements

patients with diagnosed physical disabilities that inhibit the patient from performing the oral health care instructions as part of the MID protocol

patients with more than four deciduous molars remaining

adolescents undergoing fixed or removable orthodontic treatment

An allergy to milk protein (not lactose intolerance). (Applies to intervention group only)

An allergy to the preservative, Sodium Benzoate (Applies to intervention group only)

History of severe asthma, requiring hospitalisation (Applies to intervention group only)

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)
Each of the 12 clinics enrolled in the study will be randomized to either standard treatment (control arm) or MID (intervention arm). The treatment received by participants will be determined by the study arm to which the clinic has been randomised. The allocation was not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
2/12/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
504
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 5968 0
3199
Recruitment postcode(s) [2] 5969 0
3939
Recruitment postcode(s) [3] 5970 0
3915
Recruitment postcode(s) [4] 5971 0
3095
Recruitment postcode(s) [5] 5972 0
3021
Recruitment postcode(s) [6] 5973 0
3029
Recruitment postcode(s) [7] 5974 0
3156
Recruitment postcode(s) [8] 5975 0
3195
Recruitment postcode(s) [9] 5976 0
3011
Recruitment postcode(s) [10] 5977 0
3181
Recruitment postcode(s) [11] 5978 0
3205
Recruitment postcode(s) [12] 5979 0
3031

Funding & Sponsors
Funding source category [1] 286370 0
Hospital
Name [1] 286370 0
Dental Health Services Victoria
Country [1] 286370 0
Australia
Primary sponsor type
Hospital
Name
Dental Health Services Victoria
Address
720 Swanston St
Carlton, 3053
Victoria
Country
Australia
Secondary sponsor category [1] 285086 0
None
Name [1] 285086 0
Address [1] 285086 0
Country [1] 285086 0
Other collaborator category [1] 277170 0
University
Name [1] 277170 0
University of Melbourne
Address [1] 277170 0
The University of Melbounre
Victoria 3010
Country [1] 277170 0
Australia
Other collaborator category [2] 277171 0
University
Name [2] 277171 0
Deakin University
Address [2] 277171 0
221 Burwood Highway
Burwood
Victoria 3125
Country [2] 277171 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288370 0
University of Melbourne
Ethics committee address [1] 288370 0
University of Melbourne
Victoria 3010
Ethics committee country [1] 288370 0
Australia
Date submitted for ethics approval [1] 288370 0
Approval date [1] 288370 0
13/08/2012
Ethics approval number [1] 288370 0
1237643

Summary
Brief summary
The study aims to demonstrate that the implementation of a Minimal Intervention Dentistry approach to a group of community public dental patients (adolescents aged 11-14 years) is likely to be ‘cost-effective’ compared to ‘current practice’ in achieving positive oral health outcomes for this population group.

The study targets adolescents who are assessed as being at high risk to dental caries and are currently accessing community dental clinics in Metropolitan Melbourne. Equal numbers of community dental clinics will be recruited from local government areas with low and high SEIFA indexes to join the study. The design of the Study is that of a cluster randomised control trial.

Minimal Intervention Dentistry (MID) is a multi-pronged approach which comprises of a range of strategies including prevention, early intervention, non-surgical and surgical management of the condition.

Minimal Intervention Dentistry is based on the premise that early carious lesions can be reversed through remineralisation and changes to diet and oral hygiene habits to arrest the progression of the disease.

The primary outcomes of the study are to:

Demonstrate a reduction in the number of new and progressing carious lesions amongst the participants who have undertaken this approach
Demonstrate a cost effectiveness of the MID approach in this study population

The study is scheduled for completion June 2015.
Trial website
Trial related presentations / publications
Nil
Public notes

Contacts
Principal investigator
Name 34933 0
Address 34933 0
Country 34933 0
Phone 34933 0
Fax 34933 0
Email 34933 0
Contact person for public queries
Name 18180 0
Kerina Princi
Address 18180 0
Dental Health Services Victoria
720 Swanston St
Carlton 3053
Country 18180 0
Australia
Phone 18180 0
+61 39341 1708
Fax 18180 0
Email 18180 0
[email protected]
Contact person for scientific queries
Name 9108 0
Adjunct Professor Hanny Calache
Address 9108 0
Dental Health Services Victoria
720 Swanston St
Carlton 3053
Country 9108 0
Australia
Phone 9108 0
+61 39341 1328
Fax 9108 0
Email 9108 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.