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 |
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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 |
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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 |
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Outcomes |
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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 |
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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 |