Fishman 1996.
Methods | RCT, parallel‐arm Teeth randomly assigned Conducted in a hospital‐based (Long Beach Memorial Medical Center) dental clinic in California, USA (noted as predominantly children from low‐income families). Operators not mentioned |
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Participants | 38 children, 47 teeth, mean age 5 years, age range 3.1 to 8.1 years | |
Interventions |
Group 1:Pulpotomy (ZOE); n = 24 (1 visit)
Group 2:Pulpotomy (calcium hydroxide); n = 23 (1 visit)
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Outcomes | Clinical success (no excessive tooth mobility, no subjective symptoms of pain, no tenderness to percussion, and no fistula), radiographic success (normal periodontal ligament and absence of furcation or periapical radiolucency, internal or external resorption and calcific degeneration in the remaining pulp tissue), signs of failure (excessive tooth mobility, subjective symptoms of pain, tenderness to percussion, fistula, abnormal periodontal ligament, furcation or periapical radiolucency, internal or external resorption, and calcific degeneration in the remaining pulp tissue), periapical radiolucency, internal root resorption, external root resorption, periodontal ligament widening, pulp canal obliteration (parulis, fistula or swelling): evaluation at 1, 3 and 6 months (at tooth level) | |
Notes | 47 teeth for treatment; 43 teeth from 35 children were available for evaluation after 6 months 1 month: 11 teeth in CH group and 10 teeth in ZOE group unavailable for recall; 3 months: 9 teeth in CH group and 8 teeth in ZOE group unavailable for recall; 6 months: 3 teeth in CH group and 1 tooth in ZOE group unavailable for recall Source of funding: not reported |
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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) | Low risk | Numerical code which was available only to the operator |
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 evaluation was determined by 2 examiners who had no knowledge if the experimental group of the tooth" |
Blinding of radiological outcomes assessment | Low risk | Quote: "radiologic evaluation was determined by 2 examiners who had no knowledge if the experimental group of the tooth" |
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 |