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

Borges 2012b.

Study characteristics
Methods RCT, parallel groups
Duration of study: 12 months
Setting: 1 university in Brazil
Participants 35 participants
Age: 12–19 years
Caries experience: not reported (participants at high risk of caries)
Inclusion criteria: presence of visually non‐cavitated lesions 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): 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 (Optilight LD MAX; Gnatus Equipamentos Medico‐Odontologicos Ltda); occlusion check.
Group 2 (30 teeth): oral hygiene instructions for daily tooth brushing and the use of dental floss; prophylaxis with pumice and water (no treatment).
Outcomes Primary outcome
Radiographic and clinical (cavitation, tooth sensitivity) caries progression at 12 months
Notes Borges 2012a reported 24‐ and 36‐month results – but only for the experimental group. All lesions from the control group were excluded (mainly as they had been restored as caries progression occurred).
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Each eligible tooth was assigned a number; these numbers were noted on individual pieces of paper, which were subsequently put into a sealed opaque envelope. An external examiner withdrew 1 paper at a time and allocated 30 teeth to each group.
Allocation concealment (selection bias) Low risk Each eligible tooth was assigned a number; these numbers were noted on individual pieces of paper, which were subsequently put into a sealed opaque envelope. An external examiner withdrew 1 paper at a time and allocated 30 teeth to each group.
Blinding of participants and personnel (performance bias)
All outcomes High risk No blinding of participants or operators.
Blinding of outcome assessment (detection bias)
All outcomes High risk No blinding of assessor.
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.