None listed
Conditions
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.
Interventions
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
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.
Sponsors
Dental Health Services Victoria
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
11 Years to 14 Years
Healthy volunteers
Yes
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
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)
Outcome results
None listed