Borges 2012a.
Study characteristics | ||
Methods | RCT, parallel groups Follow‐up: 12 months Setting: 1 university in Brazil |
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Participants | 30 children Age: 5–9 years Inclusion criteria: presence of 2 primary molars with non‐cavitated dentine lesions radiographically located between the enamel dentine junction and the middle 1/3rd of dentine Exclusion criteria: presence of restorations and white spot lesions or cavitations on other tooth surfaces; teeth with reported sensitivity to any type of stimulus |
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Interventions | 2 treatment arms Group 1 (30 teeth): sealant: oral hygiene instructions for daily tooth brushing and the use of dental floss; prophylaxis with pumice and water; rubber dam placement; prophylaxis with a Robinson brush containing pumice and water; acid etching with 37% phosphoric acid for 30 seconds, washing with an air‐water spray, and drying; applying a fluoride‐releasing, resin‐based sealant Fluorshield (Caulk/Dentsply, Milford, DE, USA) with a dental probe (SS White Duflex); light curing for 20 seconds with a light‐curing device (Coltolux LED (Coltene Whaledent, Altstätten, Switzerland)); occlusion check. Group 2 (30 teeth): CR: oral hygiene instructions for daily tooth brushing and the use of dental floss; anaesthesia; rubber dam isolation; cavity preparation with a diamond bur number 1012 (KG Sorensen, Barueri, São Paulo, Brazil) mounted in a high‐speed handpiece (Dabi Atlante, Ribeirao Preto, SP, Brazil); excavation of carious tissue using a dentin excavator; finishing of the cavity with a number 329 carbide bur (KG Sorensen); acid etching of enamel and dentine for 15 seconds and drying with sterile cotton; application of 2 coats of a single‐component etch‐and‐rinse adhesive system (Stae, SDI, Victoria, Australia), application of light curing to solvent for 10 seconds (Coltolux LED (Coltene Whaledent, Altstätten, Switzerland)); restoration with increments of composite resin (Ice A2 shade, SDI, Victoria, Australia) and light cuing. |
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Outcomes |
Primary outcomes Clinical efficacy (cavitation, marginal integrity of sealant or restoration) after 12 month; number of teeth failed Secondary outcomes Radiographic efficacy (dimension change of radiolucent area between baseline and interval (group 1); presence of secondary caries (group 2)) |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Used a random sampling method which assigned a number to each eligible tooth that was put into a sealed opaque envelope. The numbers were randomly selected by an examiner to allocate the teeth to each group (experimental or control). |
Allocation concealment (selection bias) | Low risk | Used a random sampling method which assigned a number to each eligible tooth that was put into a sealed opaque envelope. The numbers were randomly selected by an examiner to allocate the teeth to each group (experimental or control). |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding of participants/operators. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Only radiographic assessment blinded (a single calibrated and blinded examiner performed this evaluation). |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Attrition balanced between groups. |
Selective reporting (reporting bias) | Unclear risk | No study protocol available – insufficient information to permit judgement of low or high risk of bias. |
Other bias | Low risk | No other biases detected. |