Neither the clinicians nor the patients were blinded to the intervention. Randomization was by means of a central telephone service and comprised computer-generated random numbers used to generate a sequential allocation list, with permuted blocks of variable size (2 and 4) and stratified by center. Pain scores were recorded with a questionnaire and posted to a collection center by each patient. Secondary outcome measures were pain experienced in the subsequent 3 days, pain after the first archwire change, ibuprofen use, and appliance breakages. The primary outcome measure was pain experienced after appliance placement using a mean of 3 recordings on a scale of 0 to 10. Eligibility criteria included patients undergoing fixed maxillary and mandibular appliance therapy, aged 11 to 17 years, and able to use ibuprofen and chewing gum. Patients about to undergo orthodontic treatment with maxillary and mandibular fixed appliances were recruited and randomly allocated to an experimental chewing gum group or a control ibuprofen group. This was a 2-arm parallel design randomized controlled trial in 9 sites in the southwest of England. The aim of this randomized trial was to investigate the effect of the use of a sugar-free chewing gum vs ibuprofen on reported pain in orthodontic patients. 12 Professor, Department of Orthodontics, School of Oral and Dental Sciences, University of Bristol, Bristol, United Kingdom.11 Research dental hygiene therapist, School of Oral and Dental Sciences, University of Bristol, Bristol, United Kingdom.10 Consultant orthodontist, Royal Cornwall Hospital NHS Trust, Truro, United Kingdom.9 Consultant orthodontist, University Hospitals Bristol NHS Trust, Bristol, United Kingdom.8 Consultant orthodontist, Royal Devon and Exeter Hospitals NHS Trust, Exeter, United Kingdom.7 Consultant orthodontist, Cheltenham Hospitals NHS Trust, Cheltenham, United Kingdom.6 Consultant orthodontist, Yeovil District Hospital HS Trust, Yeovil, United Kingdom.5 Consultant orthodontist, Musgrove Park Hospital NHS Trust, Taunton, United Kingdom.4 Visiting professor, University of Exeter Medical School, Exeter, United Kingdom.3 Associate lecturer, Open University, Bath, United Kingdom.Electronic address: 2 Consultant orthodontist, Dorchester Hospital NHS Trust, Dorchester, United Kingdom. 1 Professor, Department of Orthodontics, School of Oral and Dental Sciences, University of Bristol, Bristol, United Kingdom.
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January 2023
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