Effectiveness of Low Frequency Vibration on the Rate of Canine Retraction : A Randomized Controlled Clinical Trial
Phase: NA
Conditions: Orthodontic Appliance Complication
Sponsor: mohamed abdelmotaleb

 Effectiveness of low frequency vibration on the rate  
of canine retraction:A randomized controlled clinical trial 
Authors: 
Mohamed Atfy Abd ElMotaleba; Amr Ragab El-Beialy b*; Fouad Aly El-Sharaby c; 
Amr Emad ElDakroury c 
aPrivate Practice, Cairo, Egypt. 
bAssociate Professor of orthodontics, Orthodontic Department, Faculty Dentistry, 
Cairo University. 
cProfessor of orthodontics, Orthodontic Department, Faculty Dentistry, Cairo 
University. 
The authors declare no competing interests. 
Corresponding Author: Amr El-Beialy. 
Address: 11 El Saraya St. ElManial, Cairo,  
Telephone: (+20)1006607277 
E-mail: amr.elbeialy@dentistry.cu.edu.eg 
NCT05818527 
Document Date: May 1, 2016 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Competing interest Statement 
The authors have no competing interests as defined by Nature Research, or other 
interests that might be perceived to influence the results and/or discussion reported 
in this paper. 
The results/data/figures in this manuscript have not been published elsewhere, nor 
are they under consideration (from any of the Contributing Authors) by another 
publisher. 
All of the material is owned by the authors and/or no permissions are required. 
 

ABSTRACT 
Objectives: To investigate the effectiveness of AcceleDent Aura vibrating device 
on rate of canine retraction. Materials and Methods: Thirty-two patients requiring 
extraction of upper first premolars and canine retraction were randomly allocated 
with a 1:1 ratio into either no-appliance group or the AcceleDent Aura appliance 
group. Canine retraction was done applying 150gm of retraction force using NiTi 
coil springs on 16*22 stainless steel archwires. The duration of the study was 4 
months. Digital models were obtained directly after extraction of upper first 
premolars and at monthly intervals during canine retraction for recording the 
monthly as well as the total distance moved by the canine. Digitized models were 
superimposed on the initial model and data were statistically analyzed. Anchorage 
loss, rotation, tipping, torque and root condition were evaluated using cone beam 
computed tomography imaging. Pain was evaluated by visual analog scale. Results: 
No patients were dropped-out during this study. There was no statistically significant 
difference between both groups regarding the total distance travelled by the canine 
(P=0.436), as well as the rate of canine retraction per month (P=0.17). Regarding 
the pain level, there was no statistically significant difference between the two 
groups at day 0 (P=0.721), after 24 hrs.(P=0.882), after 72 hrs. (P=0.378) and after 
7 days(P=0.964). Conclusion: AcceleDent Aura was not able to accelerate 
orthodontic tooth movement. Pain level couldn’t be reduced by vibrational force 

with an AcceleDent device during orthodontic treatment. Root condition was not 
affected by the vibrational forces. 
 
KEY WORDS: AcceleDent; Acceleration of tooth movement; Vibrating devices; 
Canine retraction; Digital models  
INTRODUCTION 
 
 
Shortening of the treatment time via accelerating orthodontic tooth 
movement (OTM) continues to be a relentless challenge and demand in the 
mainstream orthodontics. To date, several modalities have been investigated to 
accelerate OTM through mechanical, pharmacological, surgical and physical 
approaches. 
  
Vibrating devices are another example of physical acceleration of OTM. 
AcceleDent vibrating device (OrthoAccel Technologies, Houston, Texas) has been 
introduced to the market in 2009. It was intended to be used by the patients in 
conjunction with fixed orthodontic appliances or aligners, for 20 minutes per day. 
It vibrates at a frequency of 30Hz and has a force amplitude of 20 grams. The 
mechanism of action is hypothesized to be via enhancing bone remodelling through 
increased RANKL expression together with elevation in IL-1 beta levels1 with a 
result in rise of the rate of tooth movement after application of vibration in humans 

and mice, respectively. The results reported in the literature concerning the 
efficiency 
of 
these 
devices 
in acceleration 
of 
tooth 
movement are 
controversial.2,3,4,5,6 
 The aim of this study was to investigate the effectiveness of AcceleDent Aura 
vibrating device on the rate of canine retraction. The null hypothesis was that the 
there is no difference in the rate of canine retraction between AcceleDent Aura 
appliance group and no appliance group. Other side effects including pain and root 
resorption were also considered. 
MATERIALS AND METHODS 
Trial Design 
  
This study was a parallel group two arm randomized controlled clinical trial 
with 1:1 allocation ratio that was reported following the CONSORT statement.7 The 
study was approved by the Evidence Based Center, and the Research Ethics 
Committee and performed at the Faculty of Dentistry, Cairo University, Egypt . All 
patients were acquainted with the study procedures, and signed informed consents. 
No changes or modifications were done to the original methodology of the research 

after trial commencement. All methods were performed in accordance with the 
CONSORT guidelines and regulations. 
Sample Size Calculation 
  
The sample size for the current study was calculated based on the results of 
Kau et al.8 A total sample size of 52 canines was calculated to detect a large effect 
size (d=0.8) with 80% power and 5% significance level. This number has been 
increased to a total sample size of 64 canines to count for the expected sample 
attrition. The outcome variable is normally distributed. The sample size was 
calculated using G-Power program (University of Düsseldorf, Düsseldorf, 
Germany). 
Participants, Eligibility Criteria, and Settings  
 
 
 
Subjects were selected according to pre-set eligibility criteria (Table 1) and 
randomly assigned to intervention (AcceleDent Aura) or no-appliance groups using 
computer randomization sequence generation (https://www.random.org/) with 1:1 
allocation ratio. It was not possible to mask the patients or the orthodontist providing 
the treatment, however, the outcome assessor was masked to the intervention. 
 
 
All subjects received pre-adjusted MBT 0.022x0.028-inch slot brackets (3M 
Gemini metal brackets, 3M Unitek Corporation, Monrovia, A, USA) on their upper 
and lower arches excluding the upper first premolars. The upper arch wire sequence 

in the initial levelling and alignment phase was tailored according to the severity of 
crowding from 0.014-inch NiTi archwire, until reaching 0.016x0.022-inch stainless 
steel arch wire. Self-drilling miniscrews (TADs-Hubit, Korea), 1.8x8 mm were 
placed buccally perpendicular to the labial plate of bone at the mucogingival junction 
between the upper second premolar and first molar bilaterally. Indirect anchorage 
was prepared bilaterally by inserting a L-shaped 0.019x0.025-inch stainless-steel 
wire in the auxiliary tube of the upper first molar bands and fixed to the mini-screws 
with flowable composite. 
Interventions and Outcomes  
 
  
At the end of the levelling and alignment phase, the patients were referred 
for upper bilateral first premolar extraction and an upper alginate impression was 
taken. Retraction of the canine was done using NiTi coil spring delivering a force 
of 150 gm per side calibrated using digital force gauge, attached between the hook 
of the canine bracket and the first molar tube on a of 16*2 stainless steel  basal 
archwire (Figure 1). The intervention group subjects were given AcceleDent 
devices which delivered gentle micropulses (0.25 N at 30 Hz) and were instructed 
to wear them every day for 20 mins according to the manufacturer instructions. The 
patient compliance to intervention instructions were monitored by asking the patient 
and writing every day on chart how long she used it and compare this with the data 

download from the appliance that recorded their daily usage during the period of 
space closure. 
 
 
Follow-up visits were scheduled every four weeks. At each follow up visit, 
recalibration of the NiTi retraction spring was done using the same force gauge when 
necessary to maintain 150 gm force delivery. TADs stability and occlusal 
interferences during canine retraction were also regularly checked. An alginate 
impression for the upper arch was taken monthly. 
 
 
The plaster models collected (T0-T4) were digitized using desktop scanner 
(3Shape R500, 3shape, Copenhagen, Denmark) The canine retraction was assessed 
using two methods; the incremental rate of canine retraction and the total distance 
travelled by the canine. Using the 3Shape OrthoAnalyzer softwareError! 
Bookmark not defined. the four consecutive models (T1-T4) were superimposed9 
on the base model (T0) using three points registration upon the third rugae area 
(Figure 2). Colour-mapped superimposition was used to verify the accuracy of the 
superimposition. The difference in the position of the canine cusp tip was used to 
calculate the incremental rate of canine retraction (Figure 3). For intra- and inter-
rater reliability, measurements of the digital models were done by the same operator 
(NA) twice, 2 weeks apart and repeated by another operator (MA).  
 

Cone beam Computed Tomography 
 
 
Pre- and post-retraction CBCT images were obtained for each patient using 
the same CBCT machine with the following parameters: Resolution (Voxel size): 
0.3\0.3 mm, exposure time: 10-20 sec, Anode voltage: 57-90 kV, field of view 
(FOV): 6×8 cm limited to the maxilla, and anode current: 4-16 mA. A total of 36 
CBCT images were obtained at the end of the study (18 pre-retraction and 18 post-
retraction) upon which the analysis was done. 
 
 
The DICOM files obtained from the imaging centre were manipulated using 
In vivo 5 (Anatomage) version 5.3 software to perform the CBCT measurements as 
follows: Landmarks (Table 2), reference lines/planes (Table 3) (Figure 4) and 
measurements (Table 4) were all recorded in their corresponding modules. Then, an 
analysis was created and saved to be used for all pre- & post-retraction CBCT 
images. 
Measurements used in the CBCT Analysis 
 
 
Measurements of the total distance of canine retraction, the canine tipping, 
torque and rotation were analysed by measuring the angles between the long axis 
lines for the canines and the three reference planes were measured to detect tipping 
and torque movements. Also, the angle between the horizontal line of the first molar 
and the sagittal plane to detect canine rotation.  

 
 
For assessment of root resorption, the axial guided navigation method 
explained by Castro et al10 and Schwartz et al11 was used. Using the software In-vivo 
5, version 5.3(Anatomage, Inc., Santa Clara, CA 95054, USA). the pre- & post-
retraction CBCTs obtained for each patient were used to evaluate the effect of 
AcceleDent on root resorption, the linear length between the root apex and cusps tip 
was measured. 
 
The evaluation was carried by two blinded examiners. In order to fully visualize 
the root, the CBCT image was re-oriented on each root so that the cross-section 
would pass through the long axis of each canine (Figure 5).  
 
The degree of pain was measured by Visual Analog Score (VAS), these charts 
were filled by the patients for the following week after beginning of canine retraction 
at time intervals (0, 24 hours , 48 hours, 72 hours and 7 days ) and  were gathered at 
the end of the week.  The pain VAS was in the format of a chart that contained a 
series of 10-cm horizontal scales on which the patient marked the degree of pain (0 
to 10, where 0 refer to no pain and 10 refer to sever pain) at the indicated time 
periods.  
  
Statistical Analysis  
 
Data management and statistical analysis were done using Statistical Package 

for Social Sciences, Version 21.0 (SPSS Inc., Chicago III) for Windows. Shapiro-
Wilk tests of normality were used to test normality of all quantitative variable 
distributions. Canine retraction in millimetres was presented as mean and standard 
deviation (SD). Kruskal-Wallis test was used to test the difference in the incremental 
rate of retraction between the two groups. Independent t-test was used to determine 
the statistical differences in the total distance travelled. P-value <0.05 was 
considered statistically significant. All tests were two-sided. Concordance 
correlation coefficients (CCCs) were calculated to detect the intra- and inter-
examiner reliability of the measurements.