Farzanegan 2012.
| Methods | Trial design: RCT, 5 groups Location: Dental School, Mashhad University of Medical Sciences, Iran Number of centres: 1 |
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| Participants | SELECTION CRITERIA • Scheduled for fixed appliance treatment • Moderate crowding (4 to 8 mm) according to Little's irregularity index • Requiring extraction of 4 first premolars for orthodontic reasons • Extractions scheduled to be finished at least 2 weeks before placement of the orthodontic appliances • No systemic diseases and not receiving analgesic therapy • Undergoing orthodontic treatment with fixed upper and lower appliances. Participants: 50 (50 female) Number randomised: 50 (Group 1: 10; Group 2: 10; Group 3: 10; Group 4: 10; Group 5: 10) Number evaluated: not mentioned Age range: 13 years to 18 years |
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| Interventions | INTERVENTION: 1. Ibuprofen group, participants took a 400 mg ibuprofen tablet immediately after arch wire placement and at 8‐hourly intervals for 1 week if pain persisted. 2. Chewing gum group, participants chewed a sugar‐free gum (Orbit, The Wrigley Company) for 5 minutes immediately after arch wire placement and at 8‐hour intervals for 1 week if they experienced pain. 3. Soft‐viscoelastic group, participants used horseshoe‐shaped viscoelastic polyvinyl siloxane bite wafers with low toughness. Participants in these 2 groups chewed or bit down on the bite wafers for 5 minutes at 8‐hour intervals for 1 week if pain persisted. 4. Hard‐viscoelastic group, participants used horseshoe‐shaped viscoelastic polyvinyl siloxane bite wafers with moderate toughness. Participants in these 2 groups chewed or bit down on the bite wafers for 5 minutes at 8‐hour intervals for 1 week if pain persisted. CONTROL: Placebo: Participants asked to take a B₆ vitamin tablet immediately after arch wire placement and at 8‐hour intervals for 1 week if pain persisted |
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| Outcomes | Pain intensity (measured on a 100 mm VAS) after 2 hours, 6 hours and at bedtime on the day of arch wire placement, and at 24 hours, 2 days, 3 days and 7 days after first appointment. Severity of pain was recorded for 4 oral functions including chewing, biting, fitting back teeth and fitting front teeth | |
| Notes | We compared intervention groups 2, 3 and 4 against control | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "...according to their clinic entrance number and a random number table" (p. 170). This was confirmed by e‐mail communication (22 August 2015) |
| Allocation concealment (selection bias) | Unclear risk | Not mentioned in paper and clarification not given in e‐mail communication |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | A placebo was used but as it was a tablet, it is uncertain if this was an effective placebo for the three chewing intervention groups |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Participants in the control group received a placebo intervention but this was not identical so it is uncertain if it was effective |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Drop‐outs or numbers completing the study were not mentioned |
| Selective reporting (reporting bias) | Low risk | Study protocol not available, but outcomes mentioned in the methods section appeared to have been reported |
| Other bias | Low risk | Appeared to be free of other forms of bias |