Tuna 2008.
Methods | RCT, split‐mouth Teeth randomly assigned. Conducted in Turkey Setting and operators not mentioned |
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Participants | 25 children, 50 teeth, age range 5 to 8 years | |
Interventions |
Group 1:Direct pulp capping (MTA + ZOE); n = 25 (1 visit)
Group 2: Direct pulp capping (CH + ZOE); n = 25 (1 visit)
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Outcomes | Clinical success (no spontaneous pain, no tenderness of percussion, no swelling, no fistulation or no pathological mobility), radiographic success (no furcation radiolucency, no periodontal ligament space widening or no internal or external root resorption), thermal sensitivity: evaluation at 3, 6, 12, 18 and 24 months (at tooth level) | |
Notes | Reasons of dropouts: 1 child did not return for evaluation after 1 month, 1 after 9 months and 1 after 12 months because of the loss of restoration that had been placed on the pulp capping material, 1 tooth was excluded from the clinical study after 9 months and 1 tooth after 18 months, both from the CH group Lost to follow‐up: Group 1: failure to attend, n = 3; Group 2: failure to attend, n = 3; loss of restoration, n = 2 Analysed: Group 1: n = 22; Group 2: n = 20. No exclusions Source of funding: quote: "This study was supported financially by the Scientific Research Foundation of Gazi University, Ankara, Turkey (grant no. 03/2003‐15)" |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Insufficient information to make a clear judgement |
Allocation concealment (selection bias) | Unclear risk | Insufficient information to make a clear judgement |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Insufficient information to make a clear judgement |
Blinding of clinical outcomes assessment | Low risk | Quote: "...two investigators, who attended a calibration session before the follow‐up examinations, blindly evaluated the teeth clinically" |
Blinding of radiological outcomes assessment | Low risk | Quote: "...two investigators, who attended a calibration session before the follow‐up examinations, blindly evaluated the teeth radiographically" |
Incomplete outcome data (attrition bias) All outcomes | High risk | Proportion of missing outcomes > 10% children randomly assigned |
Selective reporting (reporting bias) | Unclear risk | Insufficient information to make a clear judgement |