Chen 2013.
| Methods |
Trial design: split‐mouth design, sealant material randomly assigned among tooth pair Year the study started: no information provided Follow‐up: 24 months |
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| Participants |
Location: Paediatric department of First Dental Centre, Peking University School and Hospital of Stomatology, China
Inclusion criteria: Children had to have 1 or 2 tooth pairs of totally erupted permanent first molars without caries by visual inspection and probing. Children were divided into two categories based on caries risk severity: a) children with no or one carious tooth (dmft < 2) were included in the low risk group (LR); and b) children with dmft > 5 were placed in the high caries group (HR). Children with dmft 2 to 5 were excluded. Age at baseline: 6 to 9 years (mean 7.2 yr) Gender: not detailed Baseline caries: not reported (see inclusion criteria) Number randomly assigned: 61 children with 79 tooth pairs Number evaluated: 57 children with 75 tooth pairs |
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| Interventions |
Comparison: glass ionomer sealant versus resin‐based sealant
Tooth pair: occlusal surface of 1 tooth sealed with glass ionomer sealant (light cured Fuji VII); occlusal surface of the other tooth of the tooth pair sealed with resin‐based Concise No re‐sealing Co‐interventions: preventive program that included education in oral hygiene, diet counselling, use of fluoridated toothpaste (600 ppm) and topical fluoridated foam treatment (6000 ppm) at every clinic recall (at 6 and 12 months) |
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| Outcomes | Sound or carious occlusal surface of molar
Caries status was recorded using visual‐tactile methods Caries data were reported separately for HR (high caries risk) and LR (low caries risk) groups but we decided to combine data of these groups in our analyses (because the groups were small to evaluate separately and the combined design represents more real life) |
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| Notes | Intra‐evaluator consistency: kappa co‐efficient was 0.91 (2 investigators); and inter‐evaluator consistency for diagnosis of caries (WHO criteria): kappa co‐efficient was 0.75 (2 investigators) Funding source: supported by a grant from the Peking University School and Hospital of Stomatology | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "Random numbers determined the material used to seal the teeth" |
| 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 assessor in clinical trials of this nature cannot be performed, as outcome assessor can discriminate between materials after follow‐up |
| Incomplete outcome data? (Caries efficacy outcomes) | Low risk | Missing data: 4/61 (6.6%) children after 24 months. Quote: "Reason for dropout: School transfer out of Peking; Immigrant abroad". Comment: Missing data rate under 25% |
| Selective reporting (reporting bias) | Low risk | Outcomes reported: incidence of dentinal carious lesion on treated occlusal surfaces of molars, retention. Comment: Pre‐specified caries outcomes (in methods) were reported in the 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 and with similar conditions during the follow‐up |
| Free of other bias? Co‐interventions | Low risk | Comment: Similar co‐interventions among the sealant teeth during the follow‐up. Although one of the co‐interventions was topical fluoridated foam treatment (6000 ppm) at clinic recalls of 6 and 12 months, we saw that it likely not caused bias because the intervention was marginal and similarly addressed to all sealed teeth |