Fei 1991.
Methods | RCT, parallel‐arm Teeth randomly assigned Conducted in the Pediatric Dental Clinic at the University of Southern California School of Dentistry. Operators not mentioned |
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Participants | 62 children, 83 teeth, mean age 6.7 years, age range 3.2 to 10.1 years | |
Interventions |
Group 1:Pulpotomy (formocresol); n = not stated (27 teeth analysed) (1 visit)
Group 2:Pulpotomy (ferric sulphate); n = not stated (29 teeth analysed) (1 visit)
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Outcomes | Clinical success (no symptoms of pain, tenderness to percussion, swelling, fistulation or pathological tooth mobility), radiographic success (normal periodontal ligament, absence of pathological internal root resorption, external root resorption, no intraradicular or no periapical radiolucency), signs of failure (symptoms of pain, tenderness to percussion, swelling, fistulation, pathological tooth mobility, abnormal periodontal ligament, pathological internal root resorption, external root resorption, intraradicular or periapical radiolucency), internal root resorption, pulp canal obliteration: evaluation at 3, 6 and 12 months (at tooth level) | |
Notes | 56 teeth from 48 children were available for evaluation after 12 months (Group 1: 27; Group 2: 29) Source of funding: not reported, although FS material was provided by a manufacturer Quote: "The ferric sulphate tested in this study was provided by the Ultradent Company" |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random numbers table |
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: "Clinical evaluations of the teeth were conducted by two independent examiners who had no knowledge of the group to which the particular tooth was assigned" |
Blinding of radiological outcomes assessment | Low risk | Quote: "Radiological evaluations of the teeth were conducted by two independent examiners who had no knowledge of the group to which the particular tooth was assigned" |
Incomplete outcome data (attrition bias) All outcomes | High risk | Number of randomised teeth unknown |
Selective reporting (reporting bias) | Unclear risk | Insufficient information to make a clear judgement |