The BBaRTS Healthy Teeth Behaviour Change Programme for preventing dental caries in primary school children: study protocol for a cluster randomised controlled trial

Pine et al. Trials (2016) 17:103 DOI 10.1186/s13063-016-1226-3 STUDY PROTOCOL Open Access The BBaRTS Healthy Teeth Behaviour Change Programme for preventing dental caries in primary school children: study protocol for a cluster randomised controlled trial Cynthia Pine1,2, Pauline Adair3, Louise Robinson2*, Girvan Burnside4, Paula Moynihan5, William Wade6, James Kistler6, Morag Curnow7 and Mary Henderson8 Abstract Background: Oral health behaviours such as establishing twice-daily toothbrushing and sugar control intake need parental self-efficacy (PSE) to prevent the development of childhood dental caries. A previous study has shown that behaviour change techniques (BCTs) delivered via a storybook can improve parental self-efficacy to undertake twice-daily toothbrushing. Objective: to determine whether an intervention (BBaRTS, Bedtime Brush and Read Together to Sleep), designed to increase PSE; delivered through storybooks with embedded BCTs, parenting skills and oral health messages, can improve child oral health compared to (1) an exactly similar intervention containing no behaviour change techniques, and (2) the BBaRTS intervention supplemented with home supply of fluoride toothpaste and supervised toothbrushing on schooldays. Methods/Design: A 2-year, three-arm, multicentre, cluster randomised controlled trial. Participants: children (estimated 2000–2600) aged 5–7 years and their families from 60 UK primary schools. Intervention: Test group 1: a series of eight children’s storybooks developed by a psychologist, public health dentist, science educator, children’s author and illustrators, with guidance from the Department for Education (England). The books feature animal characters and contain embedded dental health messages, parenting skills and BCTs to promote good oral health routines focused on controlling sugar intake and toothbrushing, as well as reading at bedtime. Books are given out over 2 years. Test group 2: as Test group 1 plus home supplies of fluoride toothpaste (1000 ppmF), and daily supervised toothbrushing in school on schooldays. Active Control group: series of eight books with exactly the same stories, characters and illustrations, but without BCTs, dental health messages or parenting skills. Annual child dental examinations and parental questionnaires will be undertaken. A sub-set of participants will be invited to join an embedded study of the child’s diet and salivary microbiota composition. Primary outcome measure: dental caries experience in permanent teeth at age 7–8 years. Discussion: A multi-disciplinary team was established to develop the BBaRTS Children’s Healthy Teeth Programme. The books were developed in partnership with the Department for Education (England), informed by a series of focus groups with children, teachers and parents. Trial registration: ISRCTN21461006 (date of registration 23 September 2015). Keywords: Dental caries, Behaviour change, Storybooks, Fluoride toothpaste, Free sugars, Microbiota * Correspondence: 2 R&D Department, Salford Royal NHS Foundation Trust, Mayo Building, 3rd Floor, Stott Lane, Salford M6 8HD, United Kingdom Full list of author information is available at the end of the article © 2016 Pine et al. Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Pine et al. Trials (2016) 17:103 Background Past caries experience in the primary teeth is the strongest predictor of caries occurrence in the permanent dentition [1]. The first permanent molar teeth, which are the most caries-prone teeth, begin to erupt after the fifth birthday and are mainly fully erupted during the sixth year [2]. They are most vulnerable to caries development within the first year of eruption [3]. Decay experience in these teeth account for the majority of decay in children and result in lifelong impacts and costs [4]. Therefore, preventing decay experience in these teeth would result in significant savings to dental service costs and enhanced children’s oral quality of life. Dental caries is an entirely preventable disease and there is comprehensive guidance on prevention for dental teams working in the National Health Service (NHS) in England [5] and in Scotland [6] to advise families on brushing twice daily with fluoridated toothpaste, controlling dietary sugars’ intake especially at bedtime, and for those children at high risk, (e.g. with caries experience in primary teeth) to provide evidence-based clinical procedures including fissure sealants and fluoride varnish. National guidance has been developed for the frequency of dental attendance and recall linked to disease risk category [7] and a systematic use of risk categorisation is being piloted in the new dental contract in England [8, 9]. Dental caries preventive guidance is aligned with general public health recommendations for adopting a healthy diet low in free sugars to prevent obesity [10]. These general health messages and supporting skills are delivered in a wide range of both local authority and NHS programmes and settings. However, there is strong evidence of stark oral health inequalities rooted in the social determinants of oral and general health. For caries development, the difference between a healthy state and disease initiation and progression relates to the balance between the amount and frequency of consumption of free sugars, and other potentially fermentable carbohydrates, that are metabolised by the bacteria in dental plaque producing acids as metabolic bi-products, leading to demineralisation of teeth and the presence of a favourable oral environment for remineralisation including adequate levels of fluoride [11]. In the absence of water fluoridation, the population approach to optimise fluoride exposure is through the establishment and maintenance of twice-daily toothbrushing with fluoridated toothpaste [12]. Both control of free sugars’ intake, especially at bedtime, and twicedaily brushing rely on the development and maintenance of healthy routines at home from a young age. The likelihood of these occurring is socially and culturally patterned, and depends on parental self-efficacy to establish the behaviours [13] with a supportive personal and community environment that sees these as normal and Page 2 of 10 provides the skills and materials to make these choices natural and accessible. However, in socially disadvantaged communities, there are significant barriers to establishing healthy behaviours and providing suppor (...truncated)