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. 2017 Dec 28;2017(12):CD008072. doi: 10.1002/14651858.CD008072.pub2

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:
  • 6‐8‐year‐old children in outpatient department in Wuxi Stomatological hospital

  • Symmetrical primary molars shallow and superficial dentin informed

  • Consent obtained from parents


Exclusion criteria:
  • Symptom of pulpitis and periapical periodontitis

  • Caries lesion extended to > 2/3 occlusal surface

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

  • Group 2: CT + amalgam


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
  • Succes rate was evaluated by scoring: 0 = filling was intact; 1 = defect of filling edge was < 0.5 mm. 2 = defect of filling edge was > 0.5 mm. 3 = filling maintained but was broken; 4 = filling maintained but tooth tissue was broken; 5 = partial or completed filling was off; 6 = tooth had been refilled or retreated; 7 = tooth was missing. Level 0‐1 were success and level 2‐7 were failure.

  • Children’s co‐operation was classified as:

    • co‐operative: accept treatment initiatively or slightly nervous but is in place. The process of treatment went well.

    • fear: nervous, fearful, crying and only accept treatment under language‐induction. It was a little bit difficult to do treatments.

    • compulsive: constant crying and moving the body. Refuse treatment. Coercive method was used to make children accept treatment. It was very difficult.

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