Intermittent Vibrational Force and Orthodontic Tooth Movement

Intermittent Vibrational Force and Orthodontic Tooth Movement: a Randomised Controlled Trial

The aim of this study is to compare the clinical efficiency of conventional fixed appliance orthodontic treatment with that supplemented by the daily application of cyclic forces to the dentition via a removable (AcceleDent) vibrational appliance. The primary outcome measure is rapidity of tooth alignment; whilst secondary outcome measures include pain and discomfort during treatment, rapidity of orthodontic space closure, changes in arch dimensions and root length.

Study Overview

• Status: Completed
• Conditions: Dental Crowding; Vibrational Force; Fixed Orthodontic Appliances
• Intervention / Treatment: Device: AcceleDent vibrational device; Device: Sham AcceleDent device; Other: Fixed appliance only

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects will be recruited from a sample of consecutive cases attending for routine fixed appliance orthodontic treatment with conventional pre-adjusted edgewise brackets that satisfy the following criteria: in the permanent dentition; a requirement for extraction of a premolar unit in each quadrant; incisor irregularity between 5-12 mm.

Exclusion Criteria:

• no medical contraindications; no craniofacial anomalies or cleft lip/palate;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: AcceleDent vibrational device; Fixed appliances with supplementary vibrational force	Device: AcceleDent vibrational device; Supplementary vibrational force with fixed appliances
SHAM_COMPARATOR: Sham AcceleDent device; Fixed appliances with supplementary sham device	Device: Sham AcceleDent device; Supplementary sham-vibrational device with fixed appliances
ACTIVE_COMPARATOR: Fixed appliance only; Fixed appliances only	Other: Fixed appliance only; Fixed appliance treatment only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Orthodontic tooth movement (incisor alignment)	Irregularity (crowding) of the mandibular (lower) dental arch will be measured as total contact point displacement between the six canine and incisor teeth using digital calipers (150mm ISO 9001 electronic calliper, Tesa Technology, Renens, Switzerland; resolution ± 0.01mm) from stone dental casts. Initial crowding will be measured at T1 prior to the start of treatment. Irregularity will then be measured at T2 (at first archwire change) and the initial rate of orthodontic tooth movement calculated. Irregularity will then be measured at T3 (final alignment of the teeth) to calculate overall rate of alignment.	2-12 months from start

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Discomfort during initial orthodontic tooth movement	Subjects will fill out a questionnaire relating to their experiences of pain and discomfort during the first week of fixed appliance treatment. They will be asked to rate their pain on a 10-point visual analogue scale (no pain to extreme pain) at four time-points (4 hours; 24 hours; 3 days and 1 week) following placement of the appliance. They will also record the type and quantity of any analgesia taken during this time	1 week from start
Orthodontic space closure	Orthodontic space closure will be measured as the residual distance between canine and second premolar tooth using digital calipers from stone dental casts. This distance will be measured at each visit during space closure to calculate initial and overall rate of space closure.	6-30 months from start
Root resorption	Root length of the four lower incisor teeth will be measured from a long-cone periapical radiograph taken at the start of treatment (R1) using digital callipers. A second periapical radiograph of the lower incisors will be taken following tooth alignment (R2). The length of the crown from the tip to the cemento-enamel junction will also be measured at the start (C1) and end of alignment (C2). The X-ray enlargement factor will then be calculated as C1/C2, with apical root resorption = R1-R2 x (C1/C2)	6-12 months from start

Collaborators and Investigators

• Sponsor: King's College London

Publications and helpful links

General Publications

• DiBiase AT, Woodhouse NR, Papageorgiou SN, Johnson N, Slipper C, Grant J, Alsaleh M, Khaja Y, Cobourne MT. Effects of supplemental vibrational force on space closure, treatment duration, and occlusal outcome: A multicenter randomized clinical trial. Am J Orthod Dentofacial Orthop. 2018 Apr;153(4):469-480.e4. doi: 10.1016/j.ajodo.2017.10.021.
• DiBiase AT, Woodhouse NR, Papageorgiou SN, Johnson N, Slipper C, Grant J, Alsaleh M, Cobourne MT. Effect of supplemental vibrational force on orthodontically induced inflammatory root resorption: A multicenter randomized clinical trial. Am J Orthod Dentofacial Orthop. 2016 Dec;150(6):918-927. doi: 10.1016/j.ajodo.2016.06.025.
• Woodhouse NR, DiBiase AT, Johnson N, Slipper C, Grant J, Alsaleh M, Donaldson AN, Cobourne MT. Supplemental vibrational force during orthodontic alignment: a randomized trial. J Dent Res. 2015 May;94(5):682-9. doi: 10.1177/0022034515576195. Epub 2015 Mar 10.

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (ACTUAL): November 1, 2014

Study Registration Dates

• First Submitted: November 25, 2014
• First Submitted That Met QC Criteria: December 9, 2014
• First Posted (ESTIMATE): December 11, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): December 11, 2014
• Last Update Submitted That Met QC Criteria: December 9, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: 11/LO/0056