Sakai 2009.
Methods | RCT, parallel‐arm Teeth randomly assigned. Conducted in Brazil. Operators and setting not mentioned |
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Participants | 30 children, 30 teeth, mean age 6.8 years, age range 5 to 9 years | |
Interventions |
Group 1:Pulpotomy (Portland cement); n = 15 (1 visit)
Group 2:Pulpotomy (MTA); n = 15 (1 visit)
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Outcomes | Clinical success (no spontaneous pain, no mobility, no swelling, no fistula or no smell), radiographic success (no internal root resorption and no furcation radiolucency, dentine bridge formation), swelling, pathological mobility, sinus tract, inflammation in the adjacent tissues, furcal radiolucency, internal resorption, pulp canal obliteration, dentine bridge formation: evaluation at 6, 12, 18 and 24 months (at tooth level) | |
Notes | Reasons of dropouts: Group 1: 3 (of 24‐month follow‐up) + 3 (after 24 months) exfoliations Group 2: 1 (of 18‐month follow‐up) + 1 (of 24‐month follow‐up) + 3 (after 24 months) exfoliations Source of funding: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "The primary mandibular molars were randomly assigned to MTA or PC groups by the toss of a coin" |
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 examination… which was performed by two blinded and previously calibrated investigators" |
Blinding of radiological outcomes assessment | Low risk | Quote: "Periapical radiographic examination… which was performed by two blinded and previously calibrated investigators" |
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 |