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

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:
  • Group 1: ART approach + composite

  • Group 2: CT + composite


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
  • Survival rate measured by modified Ryge criteria (A restoration was considered to have survived if it scored Alpha and Bravo for anatomical form, marginal integrity and marginal discolouration and if recurrent caries was not diagnosed) after 6, 12 and 24 months.

  • Anxiety assessed by Venham Picture Test (8 pictures representing feelings ranging from anxiety to contentment) at the end of treatment session

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.