O'Brien 1990.
Methods |
Study design: RCT, 2 parallel groups Location: Manchester UK Setting: University Dental Hospital of Manchester Number of centres: 1 Study period: not stated Funding source: "the assistance of Thomas Bolton & Johnson Limited, Stoke‐on‐Trent, England, for supplying the archwires" |
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Participants |
Inclusion criteria: patients attending university dental hospital clinic for routine Edgewise fixed appliance therapy Exclusion criteria: not stated Number randomised: 40 participants (40 arches, upper/lower 40/0) (group A: mean age 13.4 ± 3.12 years, aged from 11.5‐17.5 years; group B: male/female: 9/11, mean age 12.95 ± 3.2 years, aged from 11‐16.5 years) Number evaluated: not stated |
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Interventions |
Comparison: conventional NiTi vs superelastic NiTi Group A (n = 20, upper/lower 20/0): 0.016‐inch conventional work hardened NiTi, Nitinol (Unitek Corp) Group B (n = 20, upper/lower 20/0): 0.016‐inch superelastic NiTi, Titanol (Forestadent) They were all fitted with identical edgewise brackets. The archwire was tied with ligatures into the brackets, the operator attempting to achieve complete engagement where clinically possible. Operators: not stated |
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Outcomes | Alignment rate: tooth movement till next arch wire (indirectly) | |
Notes |
Sample size calculation: not stated Baseline comparability: for initial tooth displacement, there was no significant difference between the two groups (P > 0.05). Other information: the following completed data were acquired by personal communication: 1) participants were followed to the second data collection stage at 35 days; 2) slot size of the bracket was "probably 0.018 inch". |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "The sequence was generated by a random number generator" from personal email |
Allocation concealment (selection bias) | Low risk | Quote: "We put the arch wires into envelopes which were in a box on the clinic. The operator then took the next sequential arch wire" from personal email |
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 | Low risk | Quote: "When I recorded the tooth movement from the study casts, I did not know which group the patients had been allocated, I was therefore blinded" from personal email |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: number of participants included in the evaluation of outcomes not stated |
Selective reporting (reporting bias) | High risk |
Quote: "We attempted to record pain data but this was not sufficiently reliable for analysis" from personal email Comments: not all prespecified primary outcomes reported |
Other bias | Low risk | Comment: no other sources of bias identified |