Eden 2006.
Methods |
Design: cluster, split‐mouth RCT Number of participant: 160 Setting: dental clinic Country: Turkey Unit of randomisation: tooth Unit of analysis: tooth pairs Follow‐up: 6, 12 and 24 months Dropout: 22.5%, 29.4% and 64.4% after 6, 12 and 24 months, respectively |
|
Participants |
Number randomised (participants): 160 children (96 ART group and 64 CT group)/325 teeth (162 ART and 163 conventional)
Number analysed: 57 children/100 teeth
Age mean and SD (range): 7.0 SD = 0.3
Gender: female 82 (52%), male 75 (48%) Average DMFT score: 6.9 SD = 2.5 Dentition: primary Type of caries lesion: multiple surface caries lesion Inclusion criteria: ≥ 1 bilaterally matched pair of primary molars with class II cavited dentin lesions in different quadrants or jaws and with cavited dentin lesions presenting with an opening wide enough for the smallest excavator (0.9 mm) to penetrate Exclusion criteria: cavities dentin lesions that had pulpal involvement were excluded |
|
Interventions | Two treatment arms:
The ART procedure consisted of widening the opening in small cavities and removing thin enamel in larger cavity openings with a dental hatchet, until the enamel was free of visible demineralisation. Soft infected dentin was excavated from the cavity walls and floor with spoon excavators. No local anaesthesia was administered. Cavities were restored with composite (Pertac II) The CT procedure consisted of removing carious tissues using a micromotor and a handpiece with diamond and steel burs. The cavity was prepared following the minimal intervention concept. No local anaesthesia was administered. An omni‐matrix and interdental wooden wedges were placed before restoration. The cavities were restored with composite. The interventions were conducted by 3 dentists. |
|
Outcomes |
|
|
Notes | Funding: WHO Collaborating Centre of the Radboud University Medical Centre in Nijmegen, The Netherlands, Hu‐Friedy, Germany, and 3M ESPE, Germany Trial register number not reported Sample size not calculated Interexaminer reproducibility moderate (kappa = 0.41) |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "The cavitied dentin lesions were randomly assigned to the treatment group after stratification for gender, operator, upper/lower jaw, and when needed according to left/right side of the mouth using a validated computer software program (trial Balance)" |
Allocation concealment (selection bias) | Unclear risk | Comment: not reported |
Blinding of participants and personnel (performance bias) ‐ participant | High risk | Comment: participants aware of different treatments |
Blinding of participants and personnel (performance bias) ‐ operator All outcomes | High risk | Comment: blinding not possible ‐ operator knew the intervention |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Two calibrated independent examiners who were blinded to the treatment method provided evaluated the occlusal and approximal parts of the restorations after 6 months, 1 year and 2 years..." |
Incomplete outcome data (attrition bias) All outcomes | High risk | Quote: "Ten children with 33 restorations were not evaluated at any evaluation time" "The total number of children evaluated after 0.5, 1 and 2 years was 124, 113 and 57, respectively" Comment: loss to follow‐up high at 2 years (64.4%) |
Selective reporting (reporting bias) | Unclear risk | Comment: some results were reported in another study. Maybe there are other results not reported. |
Other bias | Low risk | Comment: split‐mouth design with the same baseline diagnosis of the teeth within a tooth pair. |