Belcheva 2014.
Methods |
Design: parallel‐group randomised controlled clinical trial Centres: 1 Date: May 2013 to December 2013 Setting: secondary care Operators: not reported |
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Participants |
Setting: University Department of Paediatric Dentistry Geographical area: Bulgaria Sample: 90 participants (45 laser versus 45 drill); number of treated teeth as well as prepared dental cavities not reported Age: 6 to 12 years Sex: not reported Baseline: participants were affected by occlusal and proximal caries involving primary and permanent molar. Methods used for caries diagnosis as well as pulpal vitality testing were not described Inclusion criteria: children aged 6 to 12 years; 1 or more dentine carious lesions (D3 threshold, WHO system), without pulp involvement or pain, located on the occlusal or proximal surface of a primary or a permanent molar; signed informed consent form from parent; native language of the child Bulgarian Exclusion criteria: previous laser treatment of carious lesions prior the present study |
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Interventions |
Intervention: Er:YAG laser: wavelength: 2940 nm pulse energy: 200 to 300 mJ/pulse (permanent teeth); 100 to 200 mJ/pulse (primary teeth) pulse duration: 250 μsec repetition rate: 20 Hz cooling method: water Control: drill in high‐speed and low‐speed dental handpieces |
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Outcomes |
Primary outcomes
Secondary outcomes
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Notes | Funding: unclear | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comment: the methodology of random sequence generation was not mentioned Quote: "A group of ninety 6‐12‐years‐old patients ... who met the inclusion criteria and were treated at the Department of Pediatric Dentistry in Plovdiv, Bulgaria during the period May – December 2013, was randomly divided into two equal treatment groups" |
Allocation concealment (selection bias) | Unclear risk | The allocation concealment was not described in the study |
Blinding of participants and personnel (performance bias) All outcomes | High risk | The type of intervention does not allow the performance of blinding |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | The trial examined episodes of pain (but not caries removal). The study provides only descriptive results regarding pain and was thus considered unclear |
Selective reporting (reporting bias) | Unclear risk | The study protocol was not available. The primary outcome caries removal was not reported |
Other bias | Unclear risk | It was unclear whether the study was funded or not |