Intermittent Vibrational Force and Orthodontic Tooth Movement

Not Applicable

Completed

• Conditions: Fixed Orthodontic Appliances; Dental Crowding; Vibrational Force
• Interventions: Other: Fixed appliance only; Device: AcceleDent vibrational device; Device: Sham AcceleDent device

• Registration Number: NCT02314975
• Lead Sponsor: King's College London

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Primary Completion: 2014-11
• Study First Submitted: 2014-11-25
• Status Verified: 2014-12
• Study First Submitted QC: 2014-12-09
• Last Update Submitted: 2014-12-09
• Study First Posted: 2014-12-11
• Last Update Posted: 2014-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fixed appliance only	Fixed appliance only	Fixed appliances only
AcceleDent vibrational device	AcceleDent vibrational device	Fixed appliances with supplementary vibrational force
Sham AcceleDent device	Sham AcceleDent device	Fixed appliances with supplementary sham device

Primary Outcome Measures

Name	Time	Method
Orthodontic tooth movement (incisor alignment)	2-12 months from start	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.

Secondary Outcome Measures

Name	Time	Method
Discomfort during initial orthodontic tooth movement	1 week from start	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
Orthodontic space closure	6-30 months from start	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.
Root resorption	6-12 months from start	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)