Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000846325
Ethics application status
Approved
Date submitted
4/06/2017
Date registered
8/06/2017
Date last updated
6/08/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
A supervised toothbrushing intervention trial in Northland New Zealand school children
Scientific title
Northland Intermediate School Children Tooth brushing trial to improve and monitor oral health outcomes
Secondary ID [1] 285265 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dental Caries 303544 0
Condition category
Condition code
Oral and Gastrointestinal 302955 302955 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
Supervised toothbrushing intervention to intervention arm. One pea sized amount of fluoridated Colgate Red Box toothpaste once daily at school for 2 mins. The intervention went for two school years and the intervention was run by a teacher aide. One large school was allocated to the intervention and 4 smaller schools to the control arm. Each school was matched by deprivation and ethnicity. The brushing occurred after lunch each day and funding provided for the brush and paste.
Intervention code [1] 298265 0
Prevention
Comparator / control treatment
Children attending control school where no 2 minute brushing occurs.
Control group
Active

Outcomes
Primary outcome [1] 302348 0
Change in caries status after 2 years with a clinical exam and radiographs. At baseline these were also recorded and a net change in caries was calculated for each child
Timepoint [1] 302348 0
Two school years
Secondary outcome [1] 335620 0
Oral health related quality of life using a validated tool the CPQ11-14
Timepoint [1] 335620 0
Two school years
Secondary outcome [2] 335715 0
Cost effectiveness using a QALY (Validated tool the CHU-9D) and the cost of treatment (resources = materials and time of clinician) of a lesion that progresses to a restoration for children in each arm against the cost of implementing the brushing programme (resources, aide time etc)
Timepoint [2] 335715 0
Two school years

Eligibility
Key inclusion criteria
All children attending school
Minimum age
10 Years
Maximum age
13 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
No consent given

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Quasi-experimental
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis
Two previously conducted tooth brushing studies were used to calculate a sample size based on their findings and a detectable difference between the two arms using the following assumptions (Rao et al, 2007; Kraivaphan et al, 2013):
(1) ICDAS will detect a 10% difference in caries increment between two the intervention arms;
(2) this difference will be detectable at 2-year follow-up;
(3) standard deviations of 1;
(4) power = 0.8;
(5) a = 0.05, two-sided t-test; and
(6) assuming 15% lost to follow-up (attrition over two years).

A total sample size of 104 (n=52 per treatment group) was required. 

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
2/02/2015
Date of last participant enrolment
Anticipated
Actual
2/03/2015
Date of last data collection
Anticipated
Actual
1/12/2016
Sample size
Target
104
Accrual to date
Final
240
Recruitment outside Australia
Country [1] 8951 0
New Zealand
State/province [1] 8951 0
Northland

Funding & Sponsors
Funding source category [1] 296655 0
Government body
Name [1] 296655 0
Ministry of Health New Zealand
Country [1] 296655 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Po Box 647
Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 295611 0
Government body
Name [1] 295611 0
Northland DHB
Address [1] 295611 0
Private Bag 9742, 0148, Whangarei
Country [1] 295611 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297881 0
Health and Disability Ethics Committee (HDEC) Northern A Health and Disability Ethics Committee (14/NTA/176).
Ethics committee address [1] 297881 0
Ministry of Health C/- MEDSAFE, Level 6, Deloitte House 10 Brandon Street PO Box 5013 Wellington 6011
Ethics committee country [1] 297881 0
New Zealand
Date submitted for ethics approval [1] 297881 0
01/09/2014
Approval date [1] 297881 0
10/10/2014
Ethics approval number [1] 297881 0
14/NTA/176

Summary
Brief summary
There are still clear inequalities in the oral health of New Zealanders, with Maori and low socio-economic families experiencing a high proportion of oral disease, mainly dental decay. The Northland population has high proportions of Maori and low socioeconomic status people; dental disease rates in children in Northland, which has no fluoridated water supply, are the highest in the country. Tooth brushing with fluoride toothpaste reduces the incidence of dental decay significantly. Studies supervising children to brush in schools have shown measurable improvements in oral health, including a pilot study in Northland. A larger scale study is needed to reach more children and to examine the feasibility of tooth brushing interventions throughout New Zealand.
The proposed research is a supervised tooth brushing trial of Intermediate-aged school children in Northland with high caries experience. All children will undergo routine dental examinations at the beginning of the study. Children will be allocated to two different arms the intervention where they will have a supervised brushing session with 1450ppm fluoride toothpaste each school day and the control where they will do as usual. Examinations will be repeated annually until they complete Intermediate school. Data will be collected to analyse oral health outcomes, and the relative cost of this programme against the current model of treating dental disease. Data will show if a brushing programme is more effective for a population suffering from high levels of dental disease.
Health and Disability Ethics Committee (HDEC) Northern A Health and Disability Ethics Committee (14/NTA/176).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 51130 0
A/Prof Lyndie Foster Page
Address 51130 0
University of Otago
PO Box 647
Dunedin 9054
Country 51130 0
New Zealand
Phone 51130 0
+6434795853
Fax 51130 0
Email 51130 0
lyndie.fosterpage@otago.ac.nz
Contact person for public queries
Name 51131 0
A/Prof Lyndie Foster Page
Address 51131 0
University of Otago
PO Box 647
Dunedin 9054
Country 51131 0
New Zealand
Phone 51131 0
+6434795853
Fax 51131 0
Email 51131 0
lyndie.fosterpage@otago.ac.nz
Contact person for scientific queries
Name 51132 0
A/Prof Lyndie Foster Page
Address 51132 0
University of Otago
PO Box 647
Dunedin 9054
Country 51132 0
New Zealand
Phone 51132 0
+6434795853
Fax 51132 0
Email 51132 0
lyndie.fosterpage@otago.ac.nz

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.