Miranda 2005.
Methods |
Design: split‐mouth RCT Number of participant: 80 Setting: dental clinic Country: Brazil Unit of randomisation: tooth Unit of analysis: tooth pairs Follow‐up: 6 and 12 months Dropout: 3.75% after 6 months and 12.5% after 12 months |
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Participants |
Number randomised (participants): 80 children/160 teeth (80 ART group and 80 CT group)
Number analysed: 70 children/140 teeth
Age mean and SD (range): 5.71 years (3‐9 years)
Gender: female 33 (41.25%), male 47 (58.75%) Average DMFT score: not reported Dentition: primary Type of caries lesion: single and multiple surface caries lesion Inclusion criteria
Exclusion criteria
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Interventions | Two treatment arms:
Teeth in the ART group were treated with hand instruments only. The restorative material was glass ionomer (Ketak‐Molar 3‐M ESPE). In CT group, cavities were filled with silver amalgam (SDI), after removing carious tooth tissues and preparation of cavities with high and low‐speed drill. Both treatments were started without use of anaesthesia. The interventions were conducted by 1 dentist |
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Outcomes |
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Notes | Funding not stated Trial register number no reported Sample size calculated Intraexaminer reproducibility not assessed |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "We used a simple randomised to two treatment cited by Pocock (1993) and a table of random numbers, randomised formed by digits from 0 to 9 in a sequence from right to left and from top to bottom" |
Allocation concealment (selection bias) | Low risk | Quote: "The concealment was performed through sealed envelopes numbered 1‐100, containing inside cards with corresponding number and an indication of the first treatment, obtained by the method mentioned, being sequentially archived. The listing and envelopes were made by a professional different to the researcher." |
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 | Low risk | Quote: "The restorations were evaluated by paediatric dentist who did not perform any treatment" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comments: low dropout rate (12.5%), reasons for missing outcome data unlikely to be related to true outcome |
Selective reporting (reporting bias) | Low risk | Comments: all prespecified (primary and secondary) outcomes reported |
Other bias | Low risk | Comments: split‐mouth design with the same baseline diagnosis of the teeth within a tooth pair |