Miles 2012.
| Methods | Trial design: RCT, 2 groups Location: Private practice, Caloundra, Australia Number of centres: 1 |
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| Participants | SELECTION CRITERIA Inclusion criteria • Aged 11 years to 15 years • Non‐extraction in the mandibular arch • No impactions or unerupted teeth • Fixed appliance from 6 to 6 in both arches • Residencing locally • Undergoing orthodontic treatment with fixed upper and lower appliances Exclusion criteria • None reported Participants: 66 (26 males, 40 females) Number randomised: 66 (intervention: 33; control: 33) Number evaluated: 60 (intervention: 30; control: 28) Mean age: 13.1 years (SD 0.2) in control group, 13 years (SD 0.2) in intervention group |
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| Interventions | INTERVENTION: vibratory stimulation (Tooth Masseuse) for 20 minutes daily CONTROL: no intervention to alleviate pain |
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| Outcomes | Discomfort intensity measured on a 100 mm VAS at 5 time points: immediately after placement, 6 to 8 hours, 1, 3 and 7 days later | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "...randomly assigned in blocks of six to ensure even numbers in the control and experimental groups" (p. 214) |
| Allocation concealment (selection bias) | Unclear risk | Not mentioned |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | "The clinician was blinded to the study participants at all appointments." (p. 216) However, the participants were not blinded to group allocation |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Participants (the outcome assessors for pain) were not blinded |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 58 of 66 randomised participants were analysed. Reasons for failure to complete and time points at which drop‐outs occurred were given. Comment: Failure to complete was reported with the reason given and these represented fewer than 20% of the sample |
| 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 |