Behavior Clinical Trial
Official title:
A Study to Examine the Impact of a 21day School Brushing Intervention on the Knowledge, Behaviour and Oral Health of School Children
In this study we aim to study the effectiveness of a specially designed 21 day Brush Day and
Night programme for school children aged 6-9 which aims to establish the habit of twice a day
toothbrushing for oral health.
The 21 day programme is led primarily by teachers with support from a oral health care
professional.
Schools will be recruited in Indonesia and Nigeria to take part in the study. Half of the
schools will run the 21 day programme with their children in school grades 1 to 3, half will
act as a control.
Background The World Health Organization reports that dental cavities affect 60-90% of
children globally. FDI World Dental Federation and Unilever Oral Care have developed public
health programmes to improve brushing habits over their 12-year partnership. The last of
these (Phase III) named Brush Day & Night aimed to educate children in brushing twice daily
with a fluoride toothpaste and gave useful information for a new project, Phase IV. The
21-day Brush Day & Night programme is an intense education activity designed to establish the
habit of brushing day and night with a fluoride toothpaste. The programme involves daily
brushing instruction and includes free toothpaste and toothbrushes.
Objective In Phase IV of the partnership, the aim is to evaluate the impact on the knowledge,
behaviour and toothbrushing habits in schoolchildren aged 6-9 years old, after a 21-day
school programme and compare with baseline and a control group. The enduring nature of the
programme will be determined by the inclusion of 8 and 24-week time points.
Methods The study is a two-arm superiority randomized controlled trial. Clusters in this
study are infant and junior schools in Indonesia and Nigeria. The study aims to recruit 20
schools, with children aged 6-9 years old, in each country.
At baseline, children in both intervention and control schools will answer a questionnaire
and have their clinical oral health assessed using the Simplified Oral Hygiene Index (OHIs)
and Decayed Missing and Filled Teeth (DMFT) index.
Children in the intervention schools will then take part in a structured 21-day Brush Day &
Night intervention.
Children in the control schools will be provided with free toothpaste and toothbrushes but
will not receive the 21-day intervention.
The questionnaires and OHIs assessment are repeated after the 21 days programme is completed
and then again at 8 weeks and 24 weeks later for all participating children.
Parents/Carers/Guardians of all children will sign the informed consent and complete
questionnaires on their own experience and attitudes to oral health and toothbrushing routine
at each of the four times points (baseline, 21-day, 8 weeks and 24 weeks).
The study will be conducted by the National Dental Associations of Indonesia and Nigeria and
was approved by the Ethics Committees of both countries.
Results:
The study is ongoing. Recruitment of schools started in Indonesia in February 2018 and in
Nigeria in April 2018 for the first part of the study. This concluded in Indonesia in
September 2018 and in Nigeria in November 2018. The second part of the study (the second half
of the schools) started in November 2018 in Indonesia and December 2018 in Nigeria.
Conclusions:
The Investigators expect to collect all the data during 2019 and publish findings from the
study by Q3 2020.
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