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Intermittent Vibrational Force and Orthodontic Tooth Movement

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ClinicalTrials.gov Identifier: NCT02314975
Recruitment Status : Completed
First Posted : December 11, 2014
Last Update Posted : December 11, 2014
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Dental Crowding Vibrational Force Fixed Orthodontic Appliances Device: AcceleDent vibrational device Device: Sham AcceleDent device Other: Fixed appliance only Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intermittent Vibrational Force and Orthodontic Tooth Movement: a Randomised Controlled Trial
Study Start Date : June 2011
Actual Primary Completion Date : November 2014

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




Primary Outcome Measures :
  1. Orthodontic tooth movement (incisor alignment) [ Time Frame: 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 :
  1. Discomfort during initial orthodontic tooth movement [ Time Frame: 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

  2. Orthodontic space closure [ Time Frame: 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.

  3. Root resorption [ Time Frame: 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)



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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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;