Skip to main content
. 2017 Dec 28;2017(12):CD008072. doi: 10.1002/14651858.CD008072.pub2

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
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
  • Child between 3‐9 years

  • ≥ 2 primary molars with similar carious lesions (equal number of surfaces involved, extent and similar depths)

  • Carious lesions in dentin with access in enamel > 1 mm and that was accessible to hand instruments

  • Teeth without pulp exposure


Exclusion criteria
  • Children without ability to co‐operate in treatment

Interventions Two treatment arms:
  • Group 1: ART approach + H‐GIC

  • Group 2: CT + amalgam


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
Outcomes
  • Success rate was assessed by ART criteria after 6 and 12 months (0 = present, in good condition, 1 = present, local marginal defect (0.5 mm), no repair needed, 2 = present, unique defect > 0.5 and < 1 mm, repair needed, 3 = present, gross marginal defect, repair needed, 4 = not present, restoration partly or completely missing, 5 = not present, restoration replaced by another restoration, 6 = tooth missing, 7= present, wear < 0.5 mm, no repair needed, 8 = present, wear > 0.5 mm, repair needed, 9 = restoration not assessed, participant not present. Codes 0, 1 and 7 were considered success and 2, 3, 4 and 8 as failure. Restorations with codes 5, 6 and 9 were excluded from the analysis.

  • Pain during the treatment was classified as absence of pain, little pain or much pain

  • Recurrent caries assessed as caries on the margin of the restorative material

Notes Funding not stated
Trial register number no reported
Sample size calculated
Intraexaminer reproducibility not assessed
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