Supplemental vibrational force does not reduce pain experience during initial alignment with fixed orthodontic appliances: a multicenter randomized clinical trial

Abstract

This prospective randomized trial investigated the effect of supplemental vibrational force on orthodontic pain during alignment with fixed-appliances. Eighty-one subjects < 20 years-old undergoing extraction-based fixed-appliance treatment were randomly allocated to supplementary (20-minutes/day) use of an intra-oral vibrational device (AcceleDent(®)) (n = 29); an identical non-functional (sham) device (n = 25) or fixed-appliances only (n = 27). Each subject recorded pain intensity (using a 100-mm visual-analogue scale) and intake of oral analgesia in a questionnaire, following appliance-placement (T1) and first-adjustment (T2) for 1-week (immediately-after, 4, 24, 72-hours and at 1-week). Mean maximum-pain for the total sample was 72.96 mm [SD 21.59; 95%CI 68.19-77.74 mm] with no significant differences among groups (P = 0.282). Subjects taking analgesics reported slightly higher maximum-pain although this was not significant (P = 0.170). The effect of intervention was independent of analgesia (P = 0.883). At T1 and T2, a statistically and clinically significant increase in mean pain was seen at 4 and 24-hours, declining at 72-hours and becoming insignificant at 1-week. For mean alignment-rate, pain-intensity and use of analgesics, no significant differences existed between groups (P > 0.003). The only significant predictor for mean pain was time. Use of an AcceleDent vibrational device had no significant effect on orthodontic pain or analgesia consumption during initial alignment with fixed appliances.

Figure 1

(A) The AcceleDent device is a small, lightweight and portable vibrational appliance that consists of an activator unit (a) and a vibrating mouthpiece (m). (B) The patient gently bites down on the occlusal surfaces of the vibrating mouthpiece for 20 minutes per day.

Figure 2. CONSORT diagram showing the flow of subjects through the trial.

Note that data were lost at T1 for 1 subject (^#11 allocated to fixed-only, but this person remained in the trial and T2 data was obtained). Note that subjects ^#22 allocated to Accel and ^#26 allocated to Accel-sham also discontinued the intervention but after the collection of T2 pain data. This has been previously reported as final alignment data was not obtained for these individuals.

Figure 3. Mean pain intensity at each time-point after T1 and T2 according to intervention (predictive margins of time with 95% CIs).