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. 2017 Jul 31;2017(7):CD001830. doi: 10.1002/14651858.CD001830.pub5

Charbeneau 1979.

Methods Trial design: split‐mouth design, treatment tooth randomly assigned among tooth pair
Year the study started: 1973
Follow‐up: 48 months
Participants Location: USA, children were from 2 schools
Inclusion criteria: children had to have at least 1 contralateral pair of caries ‐ or restoration‐free permanent first molar. Diagnosis made clinically by mirror and explorer.
Age at baseline: 5 to 8 years
Gender: no information provided
Baseline caries: no information provided
Number randomly assigned: 143 children with 229 tooth pairs
Number evaluated: 186 tooth pairs at 24 months, 193 tooth pairs at 36 months, 185 tooth pairs at 48 months
Drop‐out rate: 26/143 (18%) children at 48 months (information on numbers of children at all follow‐ups not stated).
Interventions Comparison: resin‐based sealant versus no sealant
 Tooth pair: occlusal surface of 1 tooth sealed with resin‐based sealant (second generation resin‐based autopolymerised sealant (Kerr Pit and Fissure)); occlusal surface of the other tooth of the tooth pair served as a control without sealant.The occlusal surface was considered acceptable for treatment if the occlusal mesial surface of maxillary molar was sound, even though occlusal distal surface was carious or filled.
No resealing.
 All procedures conducted in a 2‐chair mobile dental van, which provided optimal physical facilities.
Co‐interventions: no information provided
Outcomes Sound or carious or restored occlusal surface of molar and sealant retention status.
Outcomes assessed by 2 dentists
Notes Inter‐examiner agreement: 91.2% for tooth status (caries or restoration) at 36 months (2 evaluators)
Funding source: no identified funding source (authors were from university)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Sealant was applied to the isolated test tooth that was selected by using a table of random numbers."
 Comment: Adequate sequence generation
Allocation concealment (selection bias) Low risk Comment: Although the information of allocation concealment was incomplete, this domain was graded low risk of bias because we saw that in split‐mouth studies the risk of selection bias is in any case insignificant
Blinding? (Outcome assessors) High risk Comment: this domain was graded as having high risk of bias because we saw that blinding of outcome assessors in clinical trials of this nature cannot be performed, as sealants are visible
Incomplete outcome data? (Caries efficacy outcomes) Low risk Missing data: 26/143 (18%) children at 48 months.
 Comment: Drop‐out rate under 25%
Selective reporting (reporting bias) Low risk Outcomes reported: Caries response and sealant retention.
 Comment: Pre‐specified outcomes (in methods) were reported in pre‐specified way
Free of other bias? Comparability of the groups Low risk Comment: Split‐mouth design with the same baseline diagnosis of the teeth within a tooth pair (caries‐free surfaces)
Free of other bias? Co‐interventions Unclear risk No information provided