It is, therefore, critical to determine both the cost and effectiveness of different approaches, particularly in an environment of limited resource where there is a need to optimise investment. There is limited information available of the highest quality to accurately inform this choice for those commissioning services in these disadvantaged communities [ 21 ]. A previous proof-of-concept study by the authors has shown that a storybook approach can be used to improve parental self-efficacy to undertake twice-daily toothbrushing [ 23 ].
The age of the children at commencement of this trial has been chosen to be 5—7 years. Therefore, an intervention study conducted to include this post-eruption period provides a pivotal time to evaluate primary prevention of dental caries in permanent teeth. Specifically, with the following objective:. To determine whether an intervention Test group 1 designed to increase parental self-efficacy using a storybook approach with embedded behaviour change techniques BCTs for two child behaviours toothbrushing with fluoride toothpaste and reducing consumption of free sugars to within recommended levels [ 25 ], especially at bedtime can improve child oral health compared to 1 an exactly similar intervention without embedded BCTs Active Control and, 2 the intervention Test group 1 supplemented with home supply of fluoride toothpaste and supervised toothbrushing on schooldays Test group 2.
I Love to Brush My Teeth by Shelley Admont
Control versus Test group 1. Control versus Test group 2. Test group 1 versus Test group 2. This is a three-arm, multicentre cluster randomised controlled trial RCT , with blinded outcome assessment. Informed consent will be obtained for each participant. Participants will be identified from primary schools in England and Scotland, whose head teachers have agreed to participate in the study. At the beginning of the school term parents of all children entering class 1 5—6 years will be sent an information pack and informed consent document via schools.
All participants will be given reasonable time to consider the study and discuss with their family. Members of school staff will be able to answer questions and contact details for the study team will be on the information sheet. Inclusion criteria: children, aged 5—6 years, who are attending state-maintained primary schools in Kent and Newham in England, and Tayside in Scotland in which the school head teacher has given permission for their school to be included in the trial will be included in the study, subject to their parents giving written consent.
Exclusion criteria: children of the same age, in the same schools for whom parents have not given written permission for their children to take part. Parents of participants in the schools in Tayside, Scotland who are already participating in The BBaRTS trial will be sent an information pack and informed consent document for the sub-study via schools. Children will be included in the sub-study, subject to written parental consent; and will be excluded from joining the sub-study in the absence of written parental consent.
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The saliva samples will be collected using the following method. The research dental nurse will have three items for each subject: a pre-labelled collection bottle, a sterile pipette and a small sterile sample bottle. The nurse will visit the schools and bring together, in small groups, the children from whom a saliva sample will be requested. Each child will be given a collection bottle and, under nurse supervision, the top of the bottle will be removed. Each child will be asked to lean their head forward and dribble saliva from their mouth into their collection bottle.
No stimulation will be provided in the way of paraffin wax and children will be asked to gently drool the saliva naturally collecting in their mouth rather than spitting. Tissues will be provided to the children to wipe off excess saliva from their mouths. Any child who cannot provide a sample will be given extra time but if no sample is forthcoming, the child will be excused the collection and reassured. These small sample bottles will be put into a rack which allows the sample bottles to stand upright and be stored individually.
The lid of the rack will be closed forming a container which will be put into a freezer box, which will contain frozen blocks. Dental caries experience in permanent teeth at age 7—8 years. The examinations will be conducted by independent dental examiners, trained in standardised dental epidemiological survey techniques [ 27 ] and blinded to the group allocation of the school. Dental caries experience on any surface in either dentition will be recorded.
All children will be examined using sterilised or single-use mouth mirrors, Community Periodontal Index of Treatment Needs CPITN probes, a standardised dental examination lamp lux and cotton wool rolls as needed. Children will be asked to assent to the examination. Any child who does not assent and refuses to have their teeth checked will remain in the study and will not be excluded; the dental examination data will be recorded as missing data for that assessment.
Dental caries experience in permanent teeth at age 6—7 years midpoint. Oral cleanliness will be measured by plaque assessment on the buccal surfaces of upper anterior teeth at dental examinations [ 28 ]. This will be sent home and collected via the school.
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This is a validated measure examining parental attitudes, beliefs and behaviours towards dental care and includes parental self-efficacy [ 13 ]. This is a validated family self-report measure of family satisfaction with how the family operates on a day-to-day basis [ 29 ]. This validated scale measures oral health-related quality of life [ 30 ]. This scale is modified from earlier research undertaken by the team and measures parental- reported frequency of reading storybooks to their child [ 23 ].
Intake24 will be used to collect dietary information from a sub-sample of the study population. In this study it will be used to collect dietary information over three consecutive days. The contribution to intakes made by defined food groups e. Profile of oral microbiota, specifically Streptococcus mutans, lactobacilli and other caries-related bacterial taxa.
DNA will be extracted from unstimulated saliva samples and V1—V2 of the 16S ribosomal RNA genes of bacteria in the samples will be sequenced by means of the Illumina MiSeq platform using a dual-indexing barcoding approach. Operational taxonomic units OTUs will be constructed at the Proportions of mutans-group streptococci, lactobacilli, Bifidobacteriaceae and Propionibacterium acidifaciens will be compared across intervention groups using appropriate statistical tests depending on the data distribution.
Following the collection of consent forms from parents and collection of baseline dental and questionnaire data, schools will be randomised to Test group 1 test books only , Test group 2 test books and fluoride toothpaste , or Control control books. The study flow in each group is presented in Fig. Randomisation will use block randomisation stratified by recruiting area, with variable block sizes. These test books have the same animal characters in each story and contain dental health messages, parenting skills and BCTs embedded within to promote good oral health day and bedtime routines focused on controlling sugar intake and toothbrushing according to recommended levels [ 25 ] as well as reading BBaRTS Programme: Bedtime: Brush and Read Together, Sleep.
The books are designed to be read by parents to their children at bedtime. Children in the control group will be given the series of eight control books, which have been developed to comprise exactly the same stories and illustrations but which exclude the specifics on oral health messages, parenting skills and BCTs. These storybooks will be given to the control group four times a year, in the same manner and frequency as the test books. All parents will be sent a letter with each book, explaining that books are intended to be read to their child before bedtime. Daily toothbrushing will be carried out at school for children in Test group 2 books and fluoride toothpaste.
The school will be provided with age-appropriate toothbrushes and fluoridated toothpaste in line with Delivering Better Oral Health DBOH guidelines [ 5 ]. A brushing supervisor will be trained in school brushing methods in each school, including equipment storage and Case Report Form CRF completion. Supplementary toothbrushing charts will be provided to support the home brushing component.
Previous study and pilot study data on similar populations have shown that there is likely to be virtually no caries in first permanent molars at baseline, and most teeth will be unerupted [ 15 ]. As the study is cluster randomised, the intra-cluster correlation coefficient ICC must be considered when calculating sample size. Few estimates of school-level ICC are available for dental data, so a value of 0. To allow for participant dropout and non-consent, it is assumed that an average of 30 pupils per school will participate and have primary outcome data available at study end.
To allow for potential withdrawal of schools, one additional school will be recruited in each group; therefore, 60 primary schools will be randomly allocated to three clusters, taking area into account. If the assumption of 30 pupils per school holds, this will give a total sample size of A detailed statistical analysis plan will be prepared prior to data analysis. Comparison of the primary outcome variable between the groups will be conducted using multilevel logistic regression analysis, to produce estimates of odds ratios and confidence intervals, adjusting for baseline characteristics deemed to be potential confounding variables, and allowing for clustering effect.
If the overall null hypothesis cannot be rejected, no pairwise comparisons will be carried out. The potential confounders will be specified prior to analysis, and may include deprivation, age, sex and eruption status. Comparisons of secondary outcome variables between groups will be carried out using multilevel logistic or linear regression, as appropriate. Sensitivity analyses of the possible effect of missing data will be carried out using multiple imputation techniques. Independent analysis will be undertaken by psychologists not involved in the development of the books. A Delphi method will be used to validate the behaviour change techniques delivered by the intervention [ 36 , 37 ].
Therefore, it was decided the focus of the books should incorporate preventive oral health behaviours and developmental changes e. Previous research suggests that 6- to 8-year-olds prefer cartoons [ 39 ], so the style used was that of cartoon characters with vibrant colour schemes to attract young readers.
It is noted that the books are designed to be read by parents to their child.
Initially two stories were written Miles Salter and illustrated Pony Ltd. Storybook 1 depicted anthropomorphised animal characters frogs , Storybook 2 used illustrations of children dressed as animals elephants. Both stories had easy-to-read, culture-neutral named characters, depicting toothbrushing behaviour and healthy food choices as a normal part of an exciting adventure story. To evaluate the appeal and acceptability of the storybooks, the research team organised focus groups in two London schools, with teachers and parents as well as children in class 1 aged 5—6 and class 2 aged 6—7 , all of whom evaluated them.
Following analysis of focus group results and feedback it was decided that Storybook 1 should be taken forward as a concept for testing. Illustrations for the book were developed with local illustrators Pony Ltd. They advised that the books were not suitable for children to read alone, due to the reading level, but supported the books as those to be taken home and read by parents to their child at bedtime.
This aligns with existing literacy schemes in schools by encouraging children to read with parents at home. DfE colleagues recommended questions and information to guide the adult readers. These were subsequently added to the back of the book.
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