Anthony J Ireland1, Pamela Ellis2, Abbie Jordan3, Rebecca Bradley2, Paul Ewings4, Nikki E Atack5, Helen Griffiths6, Kate House7, Matthew Moore8, Scott Deacon9, Nick Wenger10, Victoria Worth11, Emma Scaysbrook11, Jonathan R Sandy12. 1. Professor, Department of Orthodontics, School of Oral and Dental Sciences, University of Bristol, Bristol, United Kingdom. Electronic address: tony.ireland@bristol.ac.uk. 2. Consultant orthodontist, Dorchester Hospital NHS Trust, Dorchester, United Kingdom. 3. Associate lecturer, Open University, Bath, United Kingdom. 4. Visiting professor, University of Exeter Medical School, Exeter, United Kingdom. 5. Consultant orthodontist, Musgrove Park Hospital NHS Trust, Taunton, United Kingdom. 6. Consultant orthodontist, Yeovil District Hospital HS Trust, Yeovil, United Kingdom. 7. Consultant orthodontist, Cheltenham Hospitals NHS Trust, Cheltenham, United Kingdom. 8. Consultant orthodontist, Royal Devon and Exeter Hospitals NHS Trust, Exeter, United Kingdom. 9. Consultant orthodontist, University Hospitals Bristol NHS Trust, Bristol, United Kingdom. 10. Consultant orthodontist, Royal Cornwall Hospital NHS Trust, Truro, United Kingdom. 11. Research dental hygiene therapist, School of Oral and Dental Sciences, University of Bristol, Bristol, United Kingdom. 12. Professor, Department of Orthodontics, School of Oral and Dental Sciences, University of Bristol, Bristol, United Kingdom.
Abstract
INTRODUCTION: 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 useibuprofen 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. REGISTRATION: International Standard Randomised Controlled Trial Number (79884739) and National Institute of Health Research (6631) portfolios. FUNDING: This research was supported by an award by the British Orthodontic Society Foundation.
RCT Entities:
INTRODUCTION: 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. REGISTRATION: International Standard Randomised Controlled Trial Number (79884739) and National Institute of Health Research (6631) portfolios. FUNDING: This research was supported by an award by the British Orthodontic Society Foundation.