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. 2021 Jul 19;2021(7):CD013039. doi: 10.1002/14651858.CD013039.pub2

Borges 2012a.

Study characteristics
Methods RCT, parallel groups
Follow‐up: 12 months
Setting: 1 university in Brazil
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
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.
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))
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.