Fernandes 1998

Methods	Location: Oslo, Norway, university clinic and 2 private practices Recruitment period: Not stated Funding source: Not stated Trial design: Parallel group RCT, 8 dentists
Participants	Inclusion criteria: Caucasian patients 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 Age group: Mean 12.6 months; Range 9‐16 years Number randomised: 128 patients, 128 arch wires Number evaluated: Not stated
Interventions	Comparison: Conventional NiTi versus superelastic NiTi Gp A (n = 65): 0.014 inch Nitonol (Unitek/Monrovia USA) Gp B (n = 63 ): 0.014 inch superelastic NiTi (Sentalloy light/GAC)
Outcomes	Pain (VAS and analgesic use), measured hourly for first 11 hours then daily for 6 days over first 7 days after bonding
Notes	Sample size calculation: Not described Brackets used and placement of brackets & arch wires standardised. Type of full arch edgewise fixed appliance not specified Other information: Authors could not be contacted
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	"randomly assigned". Method of sequence generation not described
Allocation concealment (selection bias)	High risk	Not mentioned
Blinding of participants and personnel (performance bias) Patient reported outcomes	Unclear risk	Not mentioned, but unclear whether patient awareness of arch wire type would bias results
Blinding of outcome assessment (detection bias) Clinician assessed outcomes	Unclear risk	Pain reported by participants. No operator assessed outcomes reported
Incomplete outcome data (attrition bias) All outcomes	Low risk	Some data missing from some time points in both groups. No reasons given, but unlikely to have introduced a bias
Selective reporting (reporting bias)	High risk	Analgesic use recorded but not reported. Pain reported but relative effectiveness of arch wires with regard to tooth alignment not reported
Other bias	Low risk	No other sources of bias identified