Intermittent Vibrational Force and Orthodontic Tooth Movement

Study Overview
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Brief Summary
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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.

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

Conditions
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Dental Crowding, Vibrational Force, Fixed Orthodontic Appliances

Intervention / Treatment
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* Device: AcceleDent vibrational device
* Device: Sham AcceleDent device
* Other: Fixed appliance only


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AcceleDent vibrational device<br>Fixed appliances with supplementary vibrational force | Device: AcceleDent vibrational device<br>* Supplementary vibrational force with fixed appliances<br>|
| Sham Comparator: Sham AcceleDent device<br>Fixed appliances with supplementary sham device | Device: Sham AcceleDent device<br>* Supplementary sham-vibrational device with fixed appliances<br>|
| Active Comparator: Fixed appliance only<br>Fixed appliances only | Other: Fixed appliance only<br>* Fixed appliance treatment only<br>|

What is the study measuring?
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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 |