Vargas 2006.
Methods | RCT, split‐mouth Teeth randomly assigned Conducted in the Department of Pediatric Dentistry, The University of Iowa, Iowa City, Iowa, USA. Operator was the principal investigator |
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Participants | 23 children, 60 teeth, mean age 5 years, age range 4 to 9 years | |
Interventions |
Group 1:Pulpotomy (ferric sulphate); n = 28 (1 visit)
Group 2:Pulpotomy (sodium hypochlorite); n = 32 (1 visit)
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Outcomes | Clinical failure (mobility, swelling, fistula, history of spontaneous pain), radiographic success (no external root resorption, no internal root resorption, no inter‐radicular bone destruction), overall success ((% clinical success + % radiographic success)/2), pain palpation, swelling, fistula, pathological mobility, redness, bleeding, furcation involvement, internal resorption: evaluation at 6 and 12 months (at tooth level) | |
Notes | No reason of dropouts, except "2 teeth exfoliated and were eliminated from further follow‐up" Source of funding: quote: "This research was supported by the Obermann Center for Advanced Studies Spelman Rockefeller Grant from The University of Iowa, Iowa City, Iowa" |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated random table |
Allocation concealment (selection bias) | Low risk | Quote: "subject assignment was made at the consent appointment, but allocation of the tooth according to the allocation sequence was made the day of the treatment visit"; "this allocation followed the current guidelines for randomised clinical trials put forth by CONSORT [Consolidated Standards of Reporting Trials]" |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Insufficient information to make a clear judgement |
Blinding of clinical outcomes assessment | Unclear risk | Quote: "...the clinical examination was performed by the principal investigator without immediate knowledge of which treatment has been rendered on which tooth" |
Blinding of radiological outcomes assessment | Low risk | Quote: "...all radiographs were read… by 2 co‐investigators who were blinded to the technique used" |
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 |