A 21-Day School-Based Toothbrushing Intervention in Children Aged 6 to 9 Years in Indonesia and Nigeria: Protocol for a Two-Arm Superiority Randomized Controlled Trial

Background The World Health Organization reports that dental cavities affect 60% to 90% of children globally. FDI World Dental Federation and Unilever Oral Care have developed public health programs to improve brushing habits over their 12-year partnership. The last of these (phase III) named Brush Day & Night aimed to educate children on brushing twice daily with a fluoride toothpaste and gave useful information for a new project, phase IV. The 21-day Brush Day & Night program is an intense education activity designed to establish the habit of brushing day and night with a fluoride toothpaste. The program involves daily brushing instruction and includes free toothpaste and toothbrushes. Objective The main objective of the study is to evaluate the impact of a 21-day school program on children’s oral health. As a secondary objective, we aim to evaluate the impact on the knowledge, behavior, toothbrushing habits, and quality of life in school children aged 6 to 9 years after a 21-day school program and compare with baseline and a control group as measured by the self-reported questionnaires issued to children (in particular, the self-reported brushing frequency and positive responses on fluoridated toothpaste use). The enduring nature of the program will be determined by the inclusion of 8- and 24-week time points. Methods The study is a 2-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 to 9 years 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 (OHI) and Decayed Missing and Filled Teeth 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 OHI assessments are repeated after the 21-day program is completed and again 8 weeks later 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 toward oral health and toothbrushing routine at each of the four times points (baseline, 21 days, 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, which 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 We expect to collect all the data during 2019 and publish findings from the study by March 2020. Trial Registration ClinicalTrials.gov NCT04001296; https://tinyurl.com/selxraa International Registered Report Identifier (IRRID) DERR1-10.2196/14156