Lee 2013.
Methods | Study design: randomised controlled trial, parallel design Location: Korea Number of centres: 1 Setting: university hospital Recruitment period: unclear Funding source: not reported |
|
Participants | Inclusion criteria: need for a mandibular block; no behavioural management problems; no gender, race, or ethnic restrictions Exclusion criteria: emergency cases were not selected Number of participants randomised: 134 Number of participants evaluated: 134 Number of males/females: 77 males (Group 1: 35, Group 2: 42); 57 females (Group 1: 19, Group 2: 38) Age range: Group 1: 4 to 12 years, Group 2: 3 to 12 years |
|
Interventions | Group 1 (control): conventional delivery of LA Group 2: pulling of mucosa over tip of needle at insertion of LA syringe |
|
Outcomes |
|
|
Notes | The same dentist delivered LA 2 dental students assessed children, intra and interexaminer agreements established at 90% No sample size calculation Consent and ethical approval obtained |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "randomly divided into the following 2 groups: alternative and conventional" Comment: not discussed how sequence generation was performed |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment not reported |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "this study design was not double blind, i.e., the dentist was aware of the procedure" Comment: it would not be possible for the operator to be blinded to the intervention, but this might have been a source of bias; no reference to blinding of participants |
Blinding of outcome assessment (detection bias) All outcomes | High risk | No reference to blinding of assessors. Quote: "Data recorded in the videotape were rated using the Sounds, Eyes, and Motor (SEM) scale by 2 independent evaluators (trained dental students)" Comment: not possible to blind raters to intervention |
Incomplete outcome data (attrition bias) All outcomes | High risk | Quote: "Children were excluded if technical problems occurred during the videotaping procedures", however this was not further discussed. No descriptors of how many children were excluded for this reason. Attrition in each group is unclear |
Selective reporting (reporting bias) | Low risk | The study reported all expected outcomes |
Other bias | Low risk | No further bias identified |