Harazaki 1997.
Methods | Trial design: RCT, 3 groups Location: Department of Orthodontics, Tokyo Dental College, Japan Number of centres: 1 |
|
Participants | SELECTION CRITERIA • Receiving edgewise orthodontic therapy • Undergoing orthodontic treatment with fixed upper and lower appliances Participants: 84 (27 male, 57 female) Number randomised: 84 (Group 1: 44 ; Group 2: 20; Group 3: 20) Number evaluated: 84 (Group 1: 44 ; Group 2: 20; Group 3: 20) Age range: 11 years to 34 years |
|
Interventions | INTERVENTION: Either a laser irradiation group receiving laser therapy for 30 seconds at the apical region of each tooth from a labial or lingual direction (Group 2) or a blind irradiation group receiving the same therapy without irradiation (Group 3) CONTROL: No irradiation (Group 1)| |
|
Outcomes | Questionnaire involving 5 questions exploring the timing at which the pain commenced, when pain peaked and abated, and exploring the nature and severity of the discomfort | |
Notes | We could not extract any usable data from this paper | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not mentioned |
Allocation concealment (selection bias) | Unclear risk | Not mentioned |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | A blind irradiation placebo group was included in the study |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Participants were blinded in groups 1 and 2 |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No drop‐outs |
Selective reporting (reporting bias) | Low risk | Study protocol not available, but outcomes mentioned in the methods section appeared to have been reported |
Other bias | Unclear risk | Not enough detail provided to allow an assessment |