Comparative assessment of chewing gum and ibuprofen in the management of orthodontic pain with fixed appliances: A pragmatic multicenter randomized controlled trial

Abstract

This cover sheet may not be removed from the document.Please scroll down to view the document. Methods: Patients about to undergo orthodontic treatment using upper and lower fixed appliances were recruited into this 2-arm parallel design RCT in 9 trial sites in the South West of England. They were randomly allocated to one of two groups, namely the experimental chewing gum group or control ibuprofen group. Eligibility criteria included patients undergoing upper and lower fixed appliance therapy, aged 11-17 years, who were able to use ibuprofen and chewing gum. The primary outcome measure was pain experienced using a mean of three recordings on a scale of 0-10. Secondary outcome measures were pain experienced in the subsequent three days, again after the first archwire change, the use of ibuprofen and appliance breakages. Pain scores were recorded using a questionnaire and posted to a collection centre by the patient. Randomisation was by means of a central telephone service and comprised computer-generated pseudo-random numbers used to generate a sequential allocation list, with permuted blocks of variable size (two and four) and stratified by centre. Neither clinicians nor the patients were blinded to the intervention. Patients in the control group were only permitted to use ibuprofen whilst patients in the experimental group were allowed to use ibuprofen only if they didn't get sufficient analgesia from using chewing gum.Data were analysed using the principle of Intention to Treat with multilevel modelling to reflect the structured nature of the data (scores within patient within site).Results: 1000 patients were recruited and randomised in a ratio of 1:1 to either the chewing gum or ibuprofen (control) groups. The male to female ratio was similar in both groups 3 (chewing gum 35.6%: 64.4%, ibuprofen 38.4%: 61.6%). The pain questionnaire response rates were good at approximately 84% and 83% following appliance placement (chewing gum group 419: ibuprofen group 407) and 70% and 71% following the first archwire change (chewing gum group 343: ibuprofen group 341). The primary outcome was similar for the two groups: mean pain 4.31 in the experimental (chewing gum) group and 4.17 in the control (ibuprofen) group, difference 0.14 (95% confidence interval -0.13 to 0.41). There was a suggestion that the relative pain scores for the two groups changed over time, with the chewing gum group experiencing slightly more pain on the day of bond-up and less on the subsequent three days; however, the differences were not of clinical importance. There were no significant differences for the period following archwire change. The reported use of ibuprofen was less in the chewing gum group than in the control ibuprofen group:following appliance placement the mean number of occasions ibuprofen was used was 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)); following archwire change the analogous figures were 0.8 and 1.5 occasions (difference -0.65 (-0.44 to -0.86,...

Chewing gum vs. ibuprofen in the management of orthodontic pain, a multi-centre randomised controlled trial – the effect of anxiety

“…The methodology and results of this trial have been reported elsewhere (Ireland et al 2016). At the same time patients were asked to record their levels of anxiety using a Likert scale immediately following the fitting of the appliance and the first archwire change.…”

“…As with the initial pain and chewing gum/ibuprofen use analysis, the data were analyzed using STATA version 14 (STATA Corp, USA) and the analytical approaches reported for the main trial results (Ireland et al 2016) were used here, but in this case including anxiety score in the models as a putative predictor. Specifically, multi-level models were fitted with treatment group, time point (and the interaction between treatment group and time point, since this was statistically significant) and anxiety as fixed effects, centre as a random effect and individual (nested within centre) also as a random effect; random effects in both cases were included as intercept terms.…”

“…A recent clinical trial into the effect of the use of sugarfree chewing gum on orthodontic pain with fixed appliances, showed that chewing gum use can lead to a reduction in the number of oral analgesics required to manage the pain, but it had no significant effect on the number of appliance breakages (Ireland et al 2016). As part of this trial the effect of anxiety on reported pain and analgesic usage was also investigated.…”

Intérêt prophylactique et thérapeutique des chewing-gums sans sucre en orthodontie. Une étude menée auprès de professionnels de santé et de patients

“…Son action cario-protectrice est principalement liée aux effets sur la phase minérale de l'émail, sur le processus de reminéralisation [4,7,12,14], et son effet sur la prolifération bactérienne [14,19]. Les chewinggums, de par leurs effets sur la stimulation des muscles masticatoires, diminuent significativement la douleur lors de la pose ou de la réactivation du dispositif [3,9]. Une diminution de la prise d'analgésiques a été mise en évidence chez des patients ayant recours aux chewing-gums sans sucre après la pose ou la réactivation d'un dispositif [9,15].…”

“…Les chewinggums, de par leurs effets sur la stimulation des muscles masticatoires, diminuent significativement la douleur lors de la pose ou de la réactivation du dispositif [3,9]. Une diminution de la prise d'analgésiques a été mise en évidence chez des patients ayant recours aux chewing-gums sans sucre après la pose ou la réactivation d'un dispositif [9,15]. Cependant, leur consommation durant un traitement orthodontique doit rester occasionnelle d'une part, car le brossage mécanique avec une brosse à dents et du dentifrice est le moyen le plus efficace d'assurer une bonne hygiène bucco-dentaire, mais également car ces chewing-gums sans sucre ont tendance à être assimilés par les jeunes patients ou leurs parents à des sucreries à potentiel cariogène comme les bonbons ou aux chewing-gums contenant du sucre.…”