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. 2016 Sep 15;2016(9):CD009837. doi: 10.1002/14651858.CD009837.pub2

Yazdani 2009

Methods Study design: cluster‐randomised controlled trial
Conducted in: Iran
Unit of randomisation: school class
Unit of analysis: individual
Setting: public schools in Tehran
Funded by: not disclosed
Duration of the study: 12 weeks
Participants Inclusion criteria: not reported (public schools)
Exclusion criteria: not reported
Age at baseline: 15 years
N (baseline): 417
N (controls baseline): 130
N (controls follow‐up): 123
N (interventions baseline): total n = 287
  • Group 1 (leaflet) = 148


  • Group 2 (videotape) = 139


N (interventions follow‐up): total n = 265
  • Group 1 (leaflet) = 135


  • Group 2 (videotape) = 130


Recruitment: selection of schools from a list provided by the Head Office for Education of Tehran
Gender: n = 205 boys, n = 212 girls at baseline
Interventions Intervention: Intervention was based on exposing students to oral health knowledge through a leaflet and a videotape designed for this study. Educational key messages were the same in both materials: the importance of oral health, the role of microbial plaque, frequency and methods of proper toothbrushing and flossing, importance of regular dental attendance, a healthy diet and proper use of fluorides
  • Group 1 (leaflet): The leaflet was pocket sized with coloured pictures and illustrations for each topic to maintain the student’s attention and interest. It was delivered to the leaflet group twice: at baseline and at the sixth week of the intervention period


  • Group 2 (videotape): The videotape was a 17‐minute film shown in the classroom. It was presented twice: at baseline and at the sixth week of intervention


Control: The control group underwent the dental examination but received no educational intervention at all
Duration of intervention: 12 weeks
Outcomes Dental plaque, gingival bleeding
Implementation related factors Theoretical basis: not reported
Resources for implementation: Producing educational materials for this study was inexpensive: for the leaflet, 2000 Rials (0.15 €) each, and for the videotape, 3000 Rials (0.2 €) per student, along with clinical equipment for examinations
Who delivered the intervention: Interventions were carried out in co‐operation with school authorities and volunteer teachers
PROGRESS categories assessed at baseline: not reported
PROGRESS categories analysed at outcome: not reported
Outcomes related to harms/unintended effects: not reported
Intervention included strategies to address diversity or disadvantage: not reported
Economic evaluation: Producing educational materials for this study was inexpensive: for the leaflet, 2000 Rials (0.15 €) each, and for the videotape, 3000 Rials (0.2 €) per student
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk At each of the 14 schools, among 2 to 5 classes of 15‐year‐olds, 1 class was selected randomly. Then, 14 classes (n = 417; boys, n = 205; girls, n = 212) were randomly divided into 3 groups: a leaflet group (2 boys' classes and 3 girls' classes, n = 148), a videotape group (3 boys' classes and 2 girls' classes, n = 139) and a control group (2 boys' classes and 2 girls' classes, n = 130)
Allocation concealment (selection bias) Low risk All clusters were randomised at the same time
Incomplete outcome data (attrition bias) All outcomes Unclear risk Unclear
Selective reporting (reporting bias) Low risk Published report presents all expected outcomes of interest to the review
Other bias High risk Allocated to classes that were closely located, and contamination was likely to occur
Blinding of participants and personnel (performance bias) All outcomes Low risk Students were unaware in advance of examination and intervention dates
Blinding of outcome assessment (detection bias) All outcomes Low risk At baseline 1 of the study authors and at follow‐up another experienced blinding of dentist to study groups when clinical examination was carried out

1DMFT = Decayed, Missing and Filled Teeth

2deft = decayed, extracted and filled teeth

3ECC = early childhood caries

4S‐ECC = severe early childhood caries

5SES = socioeconomic status

6dmft = decayed, missing and filled teeth

7OHE = oral health education

8MI = motivational interview

9HPS = health promoting schools

10WHO = World Health Organization

11EHCP = Essential Health Care Programme

12DMFS = Decayed, Missing and Filled Surfaces

13dmfs = decayed, missing and filled surfaces

14DHE = Dental Health Education

15OH = oral health

16WIC = Women, Infants and Children Supplemental Food Programmes

17SDT = self‐determination theory