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. 2022 Feb 11;2022(2):CD012981. doi: 10.1002/14651858.CD012981.pub2

Hotuman 1998.

Study characteristics
Methods Design: RCT with split‐mouth design
Number of participants: 52
Setting: children were recruited from paediatric dentistry section, municipal dental clinics around municipality of Arhus
Country: Denmark
Unit of randomisation: teeth within each tooth pair
Unit of analysis: tooth pairs
Follow‐up: 2–2.3 years
Dropout: 1 pair of teeth
Participants Number randomised: 52 pairs of teeth in 52 children
Number analysed: 51 pairs of teeth
Age: mean 3.7 years (range 2.11–4.11 years)
Sex: 25 boys and 27 girls
Mean dmft score at baseline: not mentioned
Inclusion criteria: children with pairs of sound primary molars
Exclusion criteria: no information provided
Baseline caries risk of participants: no information provided
Interventions 2 treatment arms
  • Autopolymerised resin sealant (Delton)

  • Light‐polymerised resin sealant (Prismashield)


Co‐intervention: none
Outcomes Study primary outcomes
  • Sealant retention

  • Caries status at the follow‐up


Diagnostic criteria for caries: caries was diagnosed at cavitation level.
Notes Funding: no information provided
Trial register: no information provided
Inter‐evaluator consistency: no information provided
Sample size: no information provided
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "The teeth within each tooth pair were randomly assigned to sealing with Delton1 or Prisma‐Shield1."
Comment: method of random sequence generation not mentioned.
Allocation concealment (selection bias) Unclear risk Comment: no information provided.
Blinding of participants and personnel (performance bias)‐Participants High risk Comment: no information provided, but difference in material may not allow for blinding of participants.
Blinding of participants and personnel (performance bias)‐ Operator High risk Quote: "All children were examined by the same dentist, who also placed all the sealants."
Comment: blinding of operator not possible as 1 was a light‐cured resin and the other was autopolymerising resin.
Blinding of outcome assessment (detection bias)
All outcomes High risk Comment: blinding of outcome assessor was not possible due to material difference in sealants.
Incomplete outcome data (attrition bias)
All outcomes Low risk Quote: "One pair was omitted because the control tooth had been extracted."
Selective reporting (reporting bias) Low risk Comment: all prespecified outcomes reported.
Other bias Low risk No evidence of any other bias.