Lin 2003.
Methods |
Design: cluster, parallel RCT (a child is a cluster) Number of participants: 58 Setting: not reported Country: China Unit of randomisation: child Unit of analysis: tooth Follow‐up: 6, 12 and 24 months Dropout: none |
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Participants |
Number randomised (participants): 58 (30 ART group and 28 CT group)/248 teeth (138 ART group and 110 CT group) Number analysed: 58 children/248 teeth Age mean and SD (range): 3‐5 years Gender: female 34 (58,6%), male 24 (41.4%) Average DMFT score: not reported Dentition: primary Type of caries lesion: not reported Inclusion criteria: primary teeth with carious lesion of enamel or dentin Exclusion criteria: not reported |
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Interventions | Two treatment arms:
The ART procedure consisted of opening the cavity using enamel hatchet and sharp excavators to remove the caries. Caries was removed from the dentino‐enamel junction using sharp spoon excavators of appropriate size before proceeding on to the floor of the cavity. The glass ionomer silver reinforced restorative was placed in the cavity. In CT caries was removed from the dentino‐enamel junction using high‐speed turbine before proceeding on to the floor of the cavity. The surfaces were then washed with water‐moistened cotton pellets and then blotted dry with fresh cotton pellets. The glass ionomer silver reinforced restorative were placed in the cavity. Use of anaesthesia was not reported in any group. The interventions were conducted by a dentist. |
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Outcomes | Success rate was assessed as:
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Notes | Funding not stated Trial register number not reported Sample size not calculated Intraexaminer reproducibility not assessed |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "The children were randomly divided into two groups" Comments: method not described. |
Allocation concealment (selection bias) | Unclear risk | Comments: not reported |
Blinding of participants and personnel (performance bias) ‐ participant | High risk | Comments: no information provided, but the participants could tell whether manual or rotary instruments were used. |
Blinding of participants and personnel (performance bias) ‐ operator All outcomes | High risk | Comments: blinding not possible ‐ operator knew the intervention. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comments: not reported |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comments: no dropouts. All participants were assessed. |
Selective reporting (reporting bias) | Low risk | Comments: results of all outcomes reported |
Other bias | High risk | Comments: baseline characteristics and details about co‐interventions were not reported. Analysis did not consider the intracluster correlation coefficient. |