Saltzman 2005.
Methods | RCT, split‐mouth Teeth randomly assigned Conducted in the University of Toronto Faculty of Dentistry Paediatric Clinic, Canada. Operators were 1 of 7 paediatric dental residents, including the primary investigator |
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Participants | 16 children, 52 teeth, mean age 5.1 years, age range 3 to 8 years | |
Interventions |
Group 1:Pulpotomy (formocresol); n = 26 (1 visit)
Group 2:Pulpotomy (MTA); n = 26 (1 visit)
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Outcomes | Clinical success (teeth remained asymptomatic, absence of a sinus tract, premature tooth loss), radiographic success (absence of furcal radiolucencies, pathological root resorption, damage to succedaneous follicle, or a combination), signs of success (teeth remained asymptomatic, absence of a sinus tract, absence of furcal radiolucencies, pathological root resorption, damage to succedaneous follicle and premature tooth loss, or a combination), furcal radiolucency, periapical radiolucency, pathological root resorption, root resorption in relation to contralateral: evaluation at (mean ± standard deviation) 2.3 ± 2.1, 5.2 ± 1.9, 9.5 ± 2.3 and 15.7 ±3 months (at tooth level) | |
Notes | 4 follow‐up visits (mean ± standard deviation): first: 2.3 ± 2.1, second: 5.2 ± 1.9, third: 9.5 ± 2.3, fourth: 15.7 ± 3.0 months Source of funding: quote: "The investigators wish to thank BioLitec and Lasers in Dentistry for the donation of the diode laser, and Dentsply for the donation of the MTA. Funding for this study was provided by the University of Toronto and Alpha Omega. The authors of this study do not have any financial interest in the commercial products used" Comment: Alpha Omega International Dental Fraternity is a Jewish philanthropic charity and presents no apparent conflict of interests |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Coin toss |
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: "clinical outcome assessments were made by the primary investigator at each follow‐up visit" |
Blinding of radiological outcomes assessment | Low risk | Quote: "radiographic outcome assessments were made by the primary investigator and one independent experienced clinician who was blind to the treatment" |
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 |