Turhani 2006.
| Methods | Trial design: RCT, 2 groups Location: Medical University of Vienna, Austria Number of centres: 1 |
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| Participants | SELECTION CRITERIA Inclusion criteria • None reported • Undergoing orthodontic treatment with fixed upper and lower appliances Exclusion criteria • Chronic pain • History of neurological and psychiatric disorders Participants: 76 (30 males, 46 females) Number randomised: 76 (intervention: 38; control: 38) Number evaluated: 76 (intervention: 38; control: 38) Mean age: 25.1 years intervention group, 21 years control group (SD not reported for either group) |
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| Interventions | INTERVENTION: Immediately after placement of one arch wire, irradiation with low‐level laser therapy (LLLT) using a dental version of Mini Laser 2075 (Helbo Photodynamic Systems GmbH & Co KG, Linz, Austria; 670 nM, 75 mW). CONTROL: Placebo laser therapy without active irradiation (participants were blinded) |
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| Outcomes | Prevalence (item 1), quality (item 2), intensity (items 3 and 4), localisation (item 3), and the time course (item 4) of subjectively perceived pain. Items 3 and 4 were evaluated with a 5‐point scale (0, no pain; 5, unbearable pain). Measured at 6, 30 and 54 hours | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | P. 371: "...randomly selected and received placebo laser treatment" (p. 371) |
| Allocation concealment (selection bias) | Unclear risk | Not mentioned |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | "The operator who applied the laser treatment and the placebo could distinguish between them, but the patients were blinded to the difference" (p. 372). On page 375, authors state the knowledge of the operator may have been subconsciously transferred to the participants. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | "The operator who applied the laser treatment and the placebo could distinguish between them, but the patients were blinded to the difference" (p. 372). On page 375, authors state the knowledge of the operator may have been subconsciously transferred to the participants. |
| 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 | Low risk | Appeared to be free of other forms of bias |