Evans 1998.
Methods |
Study design: RCT, 3 parallel groups, factorial design Location: Cardiff, Wales, UK Setting: not stated Number of centres: 2 Study period: in 1996 Funding source: Welsh Scheme for the Development of Health and Social Research |
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Participants |
Inclusion criteria: ≤ 18 years; upper and lower fixed appliances required; no previous orthodontic treatment; any initial phase of expansion with a quadhelix had been stabilised for 2 months; any initial phase of active distal molar movement had been stable for 2 months Exclusion criteria: people who may have experienced periodontal disease and hence loss of attachment Number randomised: 56 participants (112 arches, upper/lower 56/56) (age < 18 years) Number evaluated: 51 participants (98 arches, upper/lower 49/49) (47 participants had data for both arches, 2 had data for upper arches and 2 for lower arches) |
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Interventions |
Comparison: multistrand stainless steel vs martensitic NiTi vs different martensitic NiTi Group A (n = 31 arches, upper/lower 14/17): 0155‐inch multistrand stainless steel (Dentaflex, Dentarium) Group B (n = 32 arches, upper/lower 19/13): 016/022‐inch medium force active martensitic NiTi (Titanium Heat Memory Wire, American Orthodontics) Group C (n = 35 arches, upper/lower 16/19): 016/022‐inch graded force, active martensitic NiTi (Bioforce Sentalloy, GAC) Bracket types: A Company Siamese brackets 0.022 Roth prescription in Centre 1 and Orthocare Spectrum I Siamese brackets 0.022 Roth prescription in Centre 2 Operators: 6 operators |
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Outcomes | Alignment rate: tooth movement measured on LII at 4 and 8 weeks (indirectly) Time to next arch wire (no variance estimates) |
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Notes |
Sample size calculation: "100 dental arches in this trial, in other words 50 subjects (50 upper and 50 lower arches), would provide adequate statistical power (80%) to detect a significant difference in the performance of any two separate arch wires (p < 0.05)." Baseline comparability: not stated Other information: MScD dissertation reported: 1. Centre 1 ‐ A Company Siamese brackets Roth prescription 0.022, Centre 2 ‐ Orthocare Spectrum I Siamese brackets 0.022 Roth prescription; 2. Arch wire allocation was predetermined via a randomised sealed nested envelope technique. Type of ligation based on operator preference, variable and not reported. No further information was obtained from the study authors. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "Allocation was predetermined and randomized." |
Allocation concealment (selection bias) | Low risk | Quote: "randomised sealed nested envelope technique" from MScD dissertation |
Blinding of participants and personnel (performance bias) Patient reported outcomes | Unclear risk | Comment: blinding of participants and personnel not stated |
Blinding of outcome assessment (detection bias) Clinician assessed outcomes | Unclear risk | Comment: blinding of outcome assessment not stated |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: 14 arches (12.5%) excluded from analysis |
Selective reporting (reporting bias) | Low risk | Comment: planned outcomes reported |
Other bias | Unclear risk |
Quote: "The allocated arch wire was then ligated by one of six clinicians as fully as possible into the bracket with the clinicians preferred method (usually elastomeric rings)." Comment: unclear risk. MScD dissertation also reported: 1. Centre 1 ‐ A Company Siamese brackets Roth prescription 0.022, Centre 2 ‐ Orthocare Spectrum I Siamese brackets 0.022 Roth prescription. The use of brackets of different types was not randomised. Two centres used different brackets and the sample size of each centre was not stated. The effect of brackets could not be estimated. |