The Impact of a 21day School Brushing Intervention on the Knowledge, Behaviour and Oral Health of School Children

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Study to Examine the Impact of a 21day School Brushing Intervention on the Knowledge, Behaviour and Oral Health of School Children

Conditions
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Dental Plaque, Behavior, Behavior, Health

Intervention / Treatment
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* Behavioral: 21 day Brush Day and Night school programme


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children aged in school year grades 1,2 and 3 years, aged 6-9 years Be of either gender and in good general health Be willing and be able (e.g. to brush teeth and understand and respond to questions) to participate in a 21-day Brush Day and Night activity at school and at home. Planning on attending their currently registered school for at least the next seven months. Exclusion Criteria: Failure of the parent/carer/guardian to provide written informed consent. Subjects scheduled for medical or dental procedures during the duration of the study. Children who have a known allergy to any toothpaste ingredients Obvious signs of gross or untreated caries or of significant periodontal disease which in the opinion of the Dentist would affect the scientific validity of the study, or if the subject were to participate in the study would affect their wellbeing. Children or their family should have no affiliation (e.g. employee) with either the FDI or Unilever.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 9 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study is a two-arm, parallel, stratified, cluster randomised trial. Clusters in this study are infant / junior schools in Indonesia and Nigeria. Ten schools in each country will be recruited. Schools will be matched into pairs by location (urban, semi-urban, rural) and then randomised to the 'intervention' and 'control' groups. using a randomisation table.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 21 day Brush Day and Night intervention<br>The 21 day Brush Day and Night programme aims to instruct on and encourage twice a day brushing with a fluoridated toothpaste. | Behavioral: 21 day Brush Day and Night school programme<br>* Children participating in the 21 day Brush Day and Night school programme are provided with toothpaste and a toothbrush each and enjoy brushing instruction, supervised brushing, and the singing of songs to facilitate learn the importance of brushing day and night, and stickers and calendars to track progress. A celebration is held at the end of the programme with certificates and rewards. The programme is supported by colourful and attractive materials with bespoke cartoon characters. Parents are provided with educational leaflets.<br>|
| No Intervention: Control schools<br>Schools / children who receive only toothpaste / toothbrushes, no 21 day Brush Day and Night intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in reported brushing frequency and improved knowledge on recommendation to use fluoridated toothpaste | Self-reported brushing frequency (no. of times a day) and time of day (morning / evening / other). Positive responses on use of a fluoridated toothpaste. | Baseline, 21 days, 8 weeks, 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in visible plaque and debris on teeth | To measure the impact on oral health via plaque levels at baseline and after a 21-day school programme, 8 and 24 weeks later and compare with children and compare with children in the control group. Changes from Baseline will also be made Oral Health will be assessed by measuring plaque levels via the plaque levels via the Oral Hygiene Simplified Index (OHIs). | Baseline, 21 days, 8 weeks, 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Behavior, Toothbrushing, Toothpastes, Dental Caries, Education, Dental