title: Comparative assessment of chewing gum and ibuprofen in the management of orthodontic pain with fixed appliances: A pragmatic multicenter randomized controlled trial.
abstract: BACKGROUND
  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.
  
  
  METHODS
  This was a 2-arm parallel design randomized controlled trial in 9 sites in the southwest of England. 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. Eligibility criteria included patients undergoing fixed maxillary and mandibular appliance therapy, aged 11 to 17 years, and able to use ibuprofen and chewing gum. The primary outcome measure was pain experienced after appliance placement using a mean of 3 recordings on a scale of 0 to 10. Secondary outcome measures were pain experienced in the subsequent 3 days, pain after the first archwire change, ibuprofen use, and appliance breakages. Pain scores were recorded with a questionnaire and posted to a collection center by each patient. 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. Neither the clinicians nor the patients were blinded to the intervention. Patients in the control group were permitted to use ibuprofen only, and patients in the experimental group were allowed to use ibuprofen if they did not get sufficient analgesia from the chewing gum. Data were analyzed using the principle of intention to treat with multilevel modeling to reflect the structured nature of the data (scores within patient within site).
  
  
  RESULTS
  One thousand patients were recruited and randomized in a ratio of 1:1 to the chewing gum and ibuprofen (control) groups. The male-to-female ratios were similar in the groups. The pain questionnaire response rates were good at approximately 84% and 83% after appliance placement (chewing gum group, 419; ibuprofen group, 407) and 70% and 71% after the first archwire change (chewing gum group, 343; ibuprofen group, 341). The primary outcomes were similar for the 2 groups: mean pain scores, 4.31 in the chewing gum group and 4.17 in the ibuprofen group; difference, 0.14 (95% CI, -0.13 to 0.41). There was a suggestion that the relative pain scores for the 2 groups changed over time, with the chewing gum group experiencing slightly more pain on the day of bond-up and less on the subsequent 3 days; however, the differences had no clinical importance. There were no significant differences for the period after archwire change. The reported use of ibuprofen was less in the chewing gum group than in the ibuprofen group; after appliance placement, the mean numbers of occasions that ibuprofen was used were 2.1 in the chewing gum group and 3.0 in the ibuprofen group (adjusted difference, -0.96 [95% CI, -0.75 to -1.17; P <0.001]); after archwire change, the figures were 0.8 and 1.5 occasions (difference, -0.65 [-0.44 to -0.86; P <0.001]). After appliance placement and the first archwire change, there was no clinically or statistically significant difference in appliance breakages between the chewing gum and ibuprofen groups after either bond-up (7% and 8.8%, respectively) or the first archwire change (4.2% and 5.5%, respectively). No adverse events were reported.
  
  
  CONCLUSIONS
  The use of a sugar-free chewing gum may reduce the level of ibuprofen usage but has no clinically or statistically significant effect on bond failures.
  
  
  BACKGROUND
  International Standard Randomised Controlled Trial Number (79884739) and National Institute of Health Research (6631) portfolios.
  
  
  BACKGROUND
  This research was supported by an award by the British Orthodontic Society Foundation.
authors.affiliation: Professor, Department of Orthodontics, School of Oral and Dental Sciences, University of Bristol, Bristol, United Kingdom. Electronic address: tony.ireland@bristol.ac.uk.
authors.forename: Anthony J
authors.initials: AJ
authors.lastname: Ireland
authors.affiliation: Consultant orthodontist, Dorchester Hospital NHS Trust, Dorchester, United Kingdom.
authors.forename: Pamela
authors.initials: P
authors.lastname: Ellis
authors.affiliation: Associate lecturer, Open University, Bath, United Kingdom.
authors.forename: Abbie
authors.initials: A
authors.lastname: Jordan
authors.affiliation: Consultant orthodontist, Dorchester Hospital NHS Trust, Dorchester, United Kingdom.
authors.forename: Rebecca
authors.initials: R
authors.lastname: Bradley
authors.affiliation: Visiting professor, University of Exeter Medical School, Exeter, United Kingdom.
authors.forename: Paul
authors.initials: P
authors.lastname: Ewings
authors.affiliation: Consultant orthodontist, Musgrove Park Hospital NHS Trust, Taunton, United Kingdom.
authors.forename: Nikki E
authors.initials: NE
authors.lastname: Atack
authors.affiliation: Consultant orthodontist, Yeovil District Hospital HS Trust, Yeovil, United Kingdom.
authors.forename: Helen
authors.initials: H
authors.lastname: Griffiths
authors.affiliation: Consultant orthodontist, Cheltenham Hospitals NHS Trust, Cheltenham, United Kingdom.
authors.forename: Kate
authors.initials: K
authors.lastname: House
authors.affiliation: Consultant orthodontist, Royal Devon and Exeter Hospitals NHS Trust, Exeter, United Kingdom.
authors.forename: Matthew
authors.initials: M
authors.lastname: Moore
authors.affiliation: Consultant orthodontist, University Hospitals Bristol NHS Trust, Bristol, United Kingdom.
authors.forename: Scott
authors.initials: S
authors.lastname: Deacon
authors.affiliation: Consultant orthodontist, Royal Cornwall Hospital NHS Trust, Truro, United Kingdom.
authors.forename: Nick
authors.initials: N
authors.lastname: Wenger
authors.affiliation: Research dental hygiene therapist, School of Oral and Dental Sciences, University of Bristol, Bristol, United Kingdom.
authors.forename: Victoria
authors.initials: V
authors.lastname: Worth
authors.affiliation: Research dental hygiene therapist, School of Oral and Dental Sciences, University of Bristol, Bristol, United Kingdom.
authors.forename: Emma
authors.initials: E
authors.lastname: Scaysbrook
authors.affiliation: Professor, Department of Orthodontics, School of Oral and Dental Sciences, University of Bristol, Bristol, United Kingdom.
authors.forename: Jonathan R
authors.initials: JR
authors.lastname: Sandy
mesh_terms: D000293:Adolescent; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D002638:Chewing Gum; D002648:Child; D004739:England; D004868:Equipment Failure; D005260:Female; D006801:Humans; D007052:Ibuprofen / Q000627:therapeutic use*; D008297:Male; D008409:Mastication / Q000502:physiology; D016910:Orthodontic Brackets / Q000009:adverse effects*; D009969:Orthodontic Wires / Q000009:adverse effects*; D059408:Pain Management / Q000379:methods*; D010147:Pain Measurement; D014087:Tooth Movement Techniques / Q000295:instrumentation*; D016896:Treatment Outcome
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D002638:Chewing Gum; D007052:Ibuprofen