Miles 2016.
| Methods | Trial design: RCT, 2 groups Location: Private practice, Caloundra, Australia Number of centres: 1 |
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| Participants | SELECTION CRITERIA Eligibility for inclusion consisted of (1) children aged up to 16 years, (2) a fully erupted dentition from first molar forward, (3) erupted or erupting second molars, (4) no missing or previously extracted permanent teeth, (5) undergoing comprehensive orthodontic treatment with full fixed appliances, and (6) a Class II malocclusion requiring extraction of 2 maxillary premolars but no mandibular extractions. Number randomised: 40 (20 males, 20 females) Number evaluated: 40 (intervention: 20; control: 20) Mean age: 12.7 (SD 1.2) years intervention group, 13.0 (SD 1.5) control group Sex: 14 female/6 male intervention group, 12 female/8 male control group |
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| Interventions | INTERVENTION: AcceleDent Aura appliance for 20 minutes per day CONTROL: no vibration appliance All patients were indirectly bonded with conventional 0.018‐in slot, MBT prescription brackets (Victory Series; 3M Unitek, Monrovia, CA, USA) on all mandibular teeth and the maxillary premolars and molars, whereas the maxillary incisors and canines were bonded with MBT equivalent prescription self‐ligating In‐Ovation C ceramic brackets (GAC International, Bohemia, NY, USA). The arch wires were identical in both groups during the 10‐week experimental period: a 0.014‐in thermal nickel‐titanium wire (G&H Wire, Franklin, IN. USA) |
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| Outcomes | The primary outcome was the change in mandibular anterior arch perimeter over the 10 weeks of the trial. Secondary outcomes were the change in the mandibular arch irregularity index over the 10 weeks and amounts of discomfort and analgesic use during the first week of the trial | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Randomization was performed using permuted blocks of 10 randomly generated numbers with the random generation function in Excel (Microsoft, Redmond, WA, USA);..." (p. 929) |
| Allocation concealment (selection bias) | Low risk | "...the numbers were sealed in opaque envelopes and shuffled by a staff member. A clinical assistant opened an envelope for the group assignment after a patient's brackets were bonded and gave routine instructions in a closed consultation room to ensure that the operator (P.M.) was blinded" (p. 929) |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | "Patients were aware of their treatment group... The operator was blinded to the group assignment" (p. 929) |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Participants were not blinded (see above) |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No losses |
| 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 |