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. 2019 Jun 25;7:1560. Originally published 2018 Sep 26. [Version 3] doi: 10.12688/f1000research.16142.3

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)