Worthington 2001.
| Methods |
Study design: Cluster randomised controlled trial (initial phase 2 clusters, secondary phase 3 clusters) Conducted in: Europe, UK Unit of randomisation: School (32 schools) Unit of analysis: School Funded by: National Sugar Bureau |
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| Participants |
Inclusion criteria: 10‐year old children in year 5 to 6 attending primary schools in research area took part in programme but only those who were provided with positive consent were sampled for clinical exam Exclusion criteria: None reported Age at baseline: Mean age 10.1 years Gender: Not specified in paper but in original MSc document reports groups being equal in analysis Number of participants randomised: Intervention n = 166; Control n = 144 Number of participants evaluated: Intervention n = 146 (4 months); n = 151 (7 months); Control n = 135 (4 months); n = 137 (7 months n = 57 – new active and 80 remaining control) |
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| Interventions |
Comparison: A school‐based education programme delivered by dental nurses versus non‐intervention control Intervention: My Mouth Matters. 4 x 1 hour lessons in school. Lessons were designed to fit into the national curriculum. Lessons were conducted by specially trained dental facilitator (qualified dental nurse). The intervention was designed to disseminate dental health knowledge to the children. The lessons incorporated group work and home work (3 x 1 hour projects) which required the participation of parents and grandparents. In phase 1 of the study the lessons were spread over 4 months and in phase 2 over 3 months. Control: Not specified Duration of intervention: Phase 1: 4 months; Phase 2: 3 months Post‐intervention: Phase1: 4 months; Phase 2: 3 months Duration of follow‐up: At 4 months and at Phase 1: 7 months and Phase 2: none Behavioural or psychological component: Group work, active learning, school to home, family involvement, repetition, social norms Dental: Knowledge, behaviour‐health link, toothbrushing instruction and skills consisting of demonstration and instruction and the use of disclosure tablets to provide feedback on performance Nutrition: Knowledge dissemination |
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| Outcomes | Plaque: Silness and Löe – validated outcome measure (conducted on a sample of children) Oral health knowledge questionnaires (not validated). Children completed questionnaires assessing dental health knowledge; child focus groups were conducted and teacher feedback on the programme obtained |
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| Notes |
Design by/Pilot work: Pilot work with children and teachers to test programme, method of delivery and evaluation materials Power calculation: None reported |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Paper only states "schools were randomly allocated to active and control groups" (p 23). Further information supplied by author confirmed that "randomisation was done by means of a computer generated schedule" |
| Allocation concealment (selection bias) | Low risk | Further information supplied by author, "Randomisation schedule was held by trial statistician and dental nurse was informed which schools were in the active group" |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | No blinding of schools or participants due to nature of intervention but cluster randomisation at the level of the school is deemed by the authors to account for this and is taken into account during the analysis |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Blinding of assessors conducting dental examinations, 1 examiner conducted all exams throughout the trial |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Plaque index and oral health knowledge scores reported for each group |
| Selective reporting (reporting bias) | Low risk | Plaque index and oral health knowledge questionnaire responses reported for each group |
| Other bias | High risk | The outcome of plaque index was evaluated on a sample of children whose parents returned consent forms (positive consent). This is likely to have introduced bias. The sugar bureau funded the trial, but funders had no influence over the data and analysis |