Ling 2003.
Methods |
Design: split‐mouth RCT Number of participants: 106 Setting: hospital Country: China Unit of randomisation: tooth Unit of analysis: tooth pairs Follow‐up: 6, 12 and 24 months Dropout: none |
|
Participants |
Number randomised (participants): 106 participants/212 teeth (106 ART group and 106 CT group)
Number analysed: 106 children/212 teeth
Age mean and SD (range): (6‐8 years) Gender: 53 male (50%) and 53 female (50%) Average DMFT score: not reported Dentition: primary Type of caries lesion: not reported Inclusion criteria:
Exclusion criteria:
|
|
Interventions | Two treatment arms:
For ART group the cavities were filled with FX glass ionomer cement (Japan Co., Ltd), after removing carious tooth tissues and undermined enamel with a sharp excavator. In CT the cavities were filled with silver amalgam (China Iron & Steel Research Institute Group), after removing carious tooth tissues and preparation of cavities with high‐speed turbine drill. Use of anaesthesia was not reported in any group. All interventions were conducted by the same dentist |
|
Outcomes |
|
|
Notes | Funding not stated Trial register number not reported Samples size not calculated Intraexaminer reproducibility not assessed |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: “Self‐control method and randomised method were used to allocate teeth 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: participant aware of different treatments |
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 | High risk | Quote: “all the treatments and clinical examinations were done by the same operator” |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comments: all participants were assessed |
Selective reporting (reporting bias) | Unclear risk | Comments: some outcomes were not reported in the methods section but were shown in the results. |
Other bias | High risk | Comments: analysis did not consider the paired data |