Table 4. Risk of bias in Nguyen et al. 2017.
Nguyen et al. 2017 15 | ||
---|---|---|
Bias | Authors'
judgement |
Support for judgement |
Random sequence
generation (selection bias) |
Low risk | Computer-generated simple random numbers sequence with a one to one allocation
ratio. |
Allocation concealment
(selection bias) |
Low risk | Quote: Allocation occurred after induction of general anesthesia to ensure allocation
concealment. The pediatric dentist, nurse, or assistant directed subjects at the time of dental surgery to the appropriate treatment group they had been assigned to by the investigator. |
Blinding of participants and
personnel (performance bias) |
Low risk | Quote: All other contributors were blinded to generation and implementation of the
treatment assignment |
Blinding of clinical
outcomes assessment |
Low risk | Quote: A single investigator, who did not perform any pulp therapy or participate in
radiographic evaluation, performed all clinical assessments. |
Blinding of radiological
outcomes assessment |
Low risk | Quote: Two experienced pediatric dentists who did not participate in protocol
development or treatment performed radiographic assessments. It is not possible to blind the assessors due to the nature of treatment received. |
Incomplete outcome data
(attrition bias) |
Low risk | 9% drop out of 172 incisors at 12 months, due to loss to follow-up (n=13) and due to
trauma (n=2). 21% drop out of 172 incisors at 18 months, due to loss to follow-up or dropout (n =31), exfoliation (n = 3), and trauma (n = 3). |
Reporting bias | Low risk | We revised the protocol that was registered with the ClinicalTrials.gov Protocol and
Registration System (ID no. NCT02019563) |