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. 2020 Feb 27;2020(2):CD011024. doi: 10.1002/14651858.CD011024.pub2

Baghlaf 2015.

Methods Study design: randomised single‐blind trial, parallel
Location: Saudi Arabia
Number of centres: not reported
Setting: quote: "pediatric dentistry specialty clinics"
Recruitment period: November 2012 to April 2013
Funding source: not reported
Participants Inclusion criteria: age ranging from 5 to 9 years old, physically and mentally healthy, no contraindications for LA, co‐operative, as determined by a behavioural rating of 'positive' or 'definitely positive' on the Frankl scale, a diagnosis of a carious primary mandibular second molar requiring pulpotomy
Exclusion criteria: medically compromised, unco‐operative patients, lack of parental consent
Number of participants randomised: 100
Number of participants evaluated: 91: Group 1: 31, Group 2: 30, Group 3: 30
Number of males/females: 39 males, 52 females
Age range: 5 to 9 years old
Interventions Group 1: traditional LA
Group 2: computer‐controlled LA delivery system (CCLAD) as recommended by the manufacturer ‐ ID Block
Group 3: CCLAD with injection in the gingival sulcus, in a 45 degree angle ‐ intraligamental LA
Outcomes
  • Pain behaviour: assessed in 15‐second intervals. 4 pain behaviour codes were scored as present or absent: body movements, crying, restraint, and stoppage of treatment. Occurrences were summed and divided by the total number of intervals assessed to calculate mean pain‐related behaviour scores

  • Pain perception: reported following completion of LA using the Wong‐Baker Faces Pain Rating Scale

Notes CONSORT flow chart presented
Intraexaminer reliability calculated, with strong agreement
Sample size calculation performed but no references or pilot studies discussed for data extraction
Use of restraint by the assistant if needed
No discussion regarding the level of training of operator or research assistant
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "The patients were randomly assigned to one of three groups using a block randomisation technique"
Comment: technique of randomisation not specified
Allocation concealment (selection bias) Unclear risk Discussed that patients were unaware of allocation but no discussion regarding operator/investigator. Quote: "patients were not informed about the group allocation"
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Quote: "The children's eyes were shielded with standard sunglasses, thus they could not distinguish between the anesthetic delivery systems. Because STA produces audible beeps as the injection is administered, and the beeping tones cannot be turned off with a switch, the sounds were produced during all injection methods (STA system or traditional syringe) as an additional measure to ensure that the children were not aware of the method being used"
Comment: no discussion whether operator was blinded but operator could not be blinded to the intervention
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Only participants were blinded in this study
Incomplete outcome data (attrition bias) 
 All outcomes High risk No intention‐to‐treat analysis performed. The authors discussed reasons for exclusion, which included failure of the "anesthesia technique" or extensive bleeding on pulpotomy and 2 more for issues with rubber dam placing
Selective reporting (reporting bias) Low risk All recorded outcomes were reported within the results section
Other bias Low risk No further bias