Borges 2012b.
Study characteristics | ||
Methods | RCT, parallel groups Duration of study: 12 months Setting: 1 university in Brazil |
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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 |
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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). |
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Outcomes |
Primary outcome Radiographic and clinical (cavitation, tooth sensitivity) caries progression at 12 months |
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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. |