Eidelman 2001.
Methods | RCT, parallel‐arm Teeth randomly assigned Conducted in the undergraduate and graduate Pediatric Dentistry Clinics of the Hebrew University‐Hadassah School of Dental Medicine, Israel. Operators were authors |
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Participants | 26 children, 45 teeth; 32 teeth from 18 children analysed, mean age 6.4 years, age range 5 to 12 years | |
Interventions |
Group 1:Pulpotomy (formocresol); n = 17 teeth (1 visit)
Group 2:Pulpotomy (MTA); n = 15 teeth (1 visit)
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Outcomes | Signs of failure (internal root resorption, furcation radiolucency, periapical bone destruction, pain, swelling, or sinus tract), internal root resorption, furcation radiolucency, periapical bone destruction, pain, swelling, or sinus tract: evaluation at 13 (6 to 30) months (at tooth level) | |
Notes | Reasons of dropouts: quotes: "a total of 45 primary molars were pulpotomized in 26 children. Of these 32 teeth in 18 children were available for follow‐up evaluation"; "4 children with 8 teeth had less than 6 months postoperative period at the time of data analysis. 3 children with 5 teeth were not available for follow‐up examination since they moved to another city" Source of funding: not reported, although the MTA material was provided by a colleague at another university in the USA |
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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 of Yes or No |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Insufficient information to make a clear judgement of Yes or No |
Blinding of clinical outcomes assessment | High risk | Quote: "the children were examined clinically at follow‐up by one of the 3 authors who were not blind to which treatment group the subject belong" |
Blinding of radiological outcomes assessment | Low risk | Quote: "all 3 authors blindly evaluated the radiographs" |
Incomplete outcome data (attrition bias) All outcomes | High risk | Proportion of missing outcomes > 10% of children randomly assigned |
Selective reporting (reporting bias) | Unclear risk | Insufficient information to make a clear judgement |