Woodhouse 2015.
| Methods | Trial design: RCT, 3 groups Location: King’s College London Dental Institute (Guy’s Hospital); Royal Alexander Children’s Hospital, Brighton and William Harvey Hospital, Ashford; UK Number of centres: 3 |
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| Participants | SELECTION CRITERIA Inclusion criteria • Aged up to 20 years at treatment start • No medical contra‐indications, including regular medication • In permanent dentition • Mandibular arch incisor irregularity • Extraction of mandibular first premolars as part of the orthodontic treatment plan • Undergoing orthodontic treatment with fixed upper and lower appliances Exclusion criteria • None reported Participants: 81 (40 males, 41 females) Number randomised: 81 (Group 1: 29; Group 2: 25; Group 3: 27) Number evaluated at visit 1: 80 (Group 1: 29; Group 2: 25; Group 3: 26) Number evaluated at visit 2: 77 (Group 1: 28; Group 2: 24; Group 3: 25) Mean age: 14.1 (SD 1.7) years |
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| Interventions | INTERVENTION: Pre‐adjusted edgewise fixed‐appliance treatment with adjunctive daily use of a functional AcceleDent (OrthoAccel Technologies, Inc, Houston, TX, USA) vibrational device (Group 1) CONTROL: Pre‐adjusted edgewise fixed‐appliance treatment with adjunctive use of a non‐functional (sham) AcceleDent device (Group 2) and pre‐adjusted edgewise fixed‐appliance treatment alone (Group 3) Participants allocated to both the working and sham devices were instructed to use the device for 20 minutes daily The bonding method and fixed appliance was standardised between groups (3M Victory series, 3M Unitek, Monrovia, CA, USA) with a pre‐determined sequence used in each group during the period of study. Arch wires were inserted and ligated from first molar to first molar using conventional elastomerics. Arch wire progression occurred only if full bracket engagement was achievable, which required the relevant arch wire to be fully tied into the base of the bracket slot adjacent to each tie wing using elastomeric ligation. No bite planes, auxiliary arches, inter‐maxillary elastics, headgears or temporary anchorage devices were used during the period of investigation |
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| Outcomes | Pain intensity on a VAS. The primary outcome measure was maximum pain experience during initial alignment. Secondary outcomes were mean pain at each time point (4 hours, 24 hours, 3 days and 7 days) after placement of the brace and the first arch wire adjustment; alignment rate; and oral analgesic consumption during the study period | |
| Notes | Used Group 1 vs Group 2 in analysis | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "...sequence was generated by one investigator (MTC) using GraphPad online software (http://www.graphpad.com/quickcalcs/index.cfm) with unrestricted equal participant allocation (1:1:1)" (p. 3) |
| Allocation concealment (selection bias) | Low risk | Central allocation was used: "...undertaken centrally at King’s College London, independently from the clinical operators, following recruitment (allocation concealment)" (p. 3) |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Page 3: 'Treating clinicians and subjects could not be blinded to the use of AcceleDent; however, subjects were blinded to the allocation of functional or sham appliances, as both were identical in appearance (with the exception that the sham appliance did not vibrate).' |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | "Treating clinicians and subjects could not be blinded to the use of AcceleDent; however, subjects were blinded to the allocation of functional or sham appliances, as both were identical in appearance (with the exception that the sham appliance did not vibrate)." (p. 3) "The pain questionnaires and extracted data were coded appropriately, so that both outcome assessor (NRW) and statistician (SNP) were blinded to subject allocation. The coding of the data was broken after the end of the analysis and no breach of blinding was identified." (p. 3) |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 80 of 81 randomised participants were analysed at the first time point and 77 at the second. Reasons for failure to complete and the time point at which drop‐outs occurred were given and these represented fewer than 20% of the sample |
| Selective reporting (reporting bias) | Low risk | Prespecified outcomes and those mentioned in the methods section appeared to have been reported |
| Other bias | Low risk | Appeared to be free of other forms of bias |
RCT = randomised controlled trial