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 |
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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 |
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Interventions | 2 treatment arms
Co‐intervention: none |
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Outcomes |
Study primary outcomes
Diagnostic criteria for caries: caries was diagnosed at cavitation level. |
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Notes |
Funding: no information provided Trial register: no information provided Inter‐evaluator consistency: no information provided Sample size: no information provided |
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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. |