Fernandes 1998.
| Methods |
Study design: RCT, 2 parallel groups Location: Oslo, Norway Setting: an orthodontic clinic and 2 private practices Number of centres: 3 Study period: not stated Funding source: not stated |
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| Participants |
Inclusion criteria: white participants starting active orthodontic treatment, no quadhelix or other palatal expansion device present, no extraoral appliance to be used, full arch edgewise fixed appliance, no analgesics taken prior to procedure Exclusion criteria: none stated Number randomised: 128 participants (male/female 72/56; median age 12.5 years, age 9‐16 years) Number evaluated: 128 participants (136 arch wires, upper/lower 73/63) (Group A: male/female 28/35, mean age 12.5 years; Group B: male/female 28/37, mean age 12.6 years) (8 participants had data for both arches, 65 for upper arches and 55 for lower arches) |
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| Interventions |
Comparison: conventional NiTi vs superelastic NiTi Group A (n = 63 participants, 66 arches, upper/lower 35/31): 0.014‐inch Nitonol (Nitonol, Unitek) Group B (n = 65 participants, 70 arches, upper/lower 38/32): 0.014‐inch superelastic NiTi (Sentalloy, GAC) Brackets used and placement of brackets and arch wires were standardised. Type of full arch edgewise fixed appliance was not specified. Operators: 8 dentists (6 postgraduates and 2 orthodontists, instructors in the postgraduate programme) |
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| Outcomes | Pain: intensity of pain measured on a 100 mm VAS, hourly for first 11 hours then daily for 2‐7 days | |
| Notes |
Sample size calculation: not stated Baseline comparability: group A: male/female 28/35, mean age 12.5 years; group B: male/female 28/37, mean age 12.6 years Other information: we could not contact study authors |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk |
Quote: "randomly assigned" Comment: unclear risk. Method of sequence generation not stated |
| Allocation concealment (selection bias) | Unclear risk | Comment: allocation concealment not stated |
| 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 | High risk | Comment: some data missing at some time points, especially at 11 hours (24 participants in Group A and 25 participants in Group B, totally 49 participants, 38.3%) |
| Selective reporting (reporting bias) | Low risk | Comment: planned outcomes reported |
| Other bias | Low risk | Comment: no other sources of bias identified |