Ibricevic 2000.
Methods | RCT, parallel‐arm Children randomly assigned Setting not mentioned. Conducted in Kuwait. Operator was 1 senior paedodontist |
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Participants | 70 children, 164 teeth, mean age 4.3 years, age range 3 to 6 years | |
Interventions |
Group 1:Pulpotomy (formocresol); n = 80 (1 visit)
Group 2:Pulpotomy (ferric sulphate); n = 84 (1 or 2 visits)
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Outcomes | Clinical success (absence of any fistula, abscess, swelling, spontaneous pain or pathological mobility), radiological failure (normal periodontal ligament space, no pathological internal or external root resorption and no intraradicular or periapical radiolucency), internal root resorption, periapical bone destruction, inter‐radicular bone destruction, succedaneous tooth structural anomaly: evaluation at 3 to 20 and 46 to 48 months (at tooth level) Signs of failure (internal root resorption, furcation radiolucency, periapical bone destruction, or a combination): evaluation at 46 to 48 months (at tooth level) |
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Notes | The first 70 teeth were all treated within 1 month. The pulpotomy therapy of a further 124 primary molars was performed on the same children, during the following 6 months. On the final recall after 42 to 48 months, only 60 children appeared within the 4 months' recall period Clinical follow‐up: every 3 months Radiographic follow‐up: 6, 20 and 42 to 48 months |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Alternate allocation |
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 | High risk | Quote: "The clinical follow‐up by the same examiner who had performed all pulpotomies and was aware to which treatment groups the subjects belonged" |
Blinding of radiological outcomes assessment | Low risk | Quote: "Both authors, blindly, evaluated radiographs" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing data |
Selective reporting (reporting bias) | Unclear risk | Insufficient information to make a clear judgement |