Grewal 2016.
Methods | RCT, split‐mouth Children randomly assigned Conducted at the Outpatient Department of Paediatric Dentistry, Punjab Government Dental College and Hospital, Amritsar, Punjab, India. Operators not mentioned. |
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Participants | 20 children, 40 teeth, mean age 7.35 years, age range 5 to 10 years | |
Interventions |
Group 1:Pulpotomy (Biodentine); n = 20 (2 visits)
Group 2:Pulpotomy (CH); n = 20 (2 visits)
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Outcomes | Pain, swelling: evaluation at 3, 6 and 12 months; mean dentin thickness, internal root resorption: evaluation at 6 and 12 months; colour matching, marginal discolouration, secondary caries, anatomic form, surface texture, marginal integrity, pulp sensitivity: evaluation at 12 months | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computerised random‐number |
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: "Blinded clinical and radiographic outcomes were observed" |
Blinding of radiological outcomes assessment | Low risk | Quote: "Blinded clinical and radiographic outcomes were observed" |
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 |