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

Peng 2004

Methods Study design: quasi‐experimental, controlled before‐and‐after study
Conducted in: Hongshan District of Wuhan City, Hubei Province, China
Unit of randomisation: school
Unit of analysis: individual
Setting: primary school
Funded by: "This study was supported by the Hubei Committee for Oral Health, PR China and the WHO Collaborating Centre for Community Oral Health Programs and Research, University of Copenhagen, Denmark"
Duration of the study: 2 years
Participants Inclusion criteria: not reported
Exclusion criteria: not reported
Age at baseline: 6.5 ± 0.4 years
Total N at baseline: 1143
N (controls baseline): group C, 370
N (controls follow‐up): not specified. Total dropout rate, 19.9%
N (interventions baseline): group G, 363; group E, 410
N (interventions follow‐up): not specified (total dropout rate, 19.9%)
Recruitment: All children in grade 1 were recruited
Gender
  • Group G = 54.8% male


  • Group E = 52% male


  • Group C = 53% male

Interventions Intervention: oral health education and sugar‐free chewing gum programme. Two intervention groups: group G and group E
Group E: WHO HPS approach (school teachers involved, classroom activities: 2‐day training workshop, OHE package for teachers, OH instruction given monthly to children along with supervised toothbrushing, parent engagement sessions around OH instructions); implementation monitored by senior dental advisor every 3 months through school visits
Group G: all OHE in group E plus sugar‐free gum (4 times/d, sessions supervised by teachers and parents); gum supplied by school to parents
Control: 1 control group C: no specific intervention. Head teachers were aware of intervention programme. Children received toothpaste at the end of the trial
Duration of intervention: 2 years
Outcomes DMFS12/DMFT
Bleeding scores
Implementation related factors Theoretical basis: health promoting schools
Resources for implementation: teacher time, sugar‐free chewing gum, training package
Who delivered the intervention: teachers and a senior public health dentist
PROGRESS categories assessed at baseline: gender
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: not reported
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Method of sequence generation not described ‐ study states only: “nine primary schools were chosen at random from the district and all children from grade 1 were recruited”
Allocation concealment (selection bias) Unclear risk Unclear
Incomplete outcome data (attrition bias) All outcomes Low risk Dropout rate was about 15% overall (14% group E; 13% G and 17% C groups)
No reasons for dropouts were provided. Study authors considered that dropout rates would not have any serious effect on outcome evaluation
Selective reporting (reporting bias) Low risk Published report presents all expected outcomes of interest to the review
Other bias Unclear risk Group G had higher caries level at baseline compared with groups C and E, although this difference was non‐significant
Blinding of participants and personnel (performance bias) All outcomes Low risk Examiners were blinded. Details of the intervention were explained to parents of the children and teachers. It may not have been possible to blind participants owing to the nature of the study design
Blinding of outcome assessment (detection bias) All outcomes High risk Not blinded