Male and female subjects will randomly assigned to this group to receive fixed appliance orthodontic treatment in conjunction with vibration therapy (daily use of OrthoAccel Aura device for 20 minutes/day) during the study period.

Male and female subjects will randomly assigned to this group to receive fixed appliance orthodontic treatment only and no vibration treatment.

Subjects will randomly assigned to this group to receive fixed appliance orthodontic treatment in conjunction with vibration therapy (daily use of OrthoAccel Aura device for 20 minutes/day) during the study period.
Vibration Device: Subjects receiving the OrthoAccel Aura device will be instructed to use the device for 20 minutes/day per the manufacturer's instructions during the study period.

Vibration Device+Fixed Appliance Tx

Subjects will randomly assigned to this group to receive fixed appliance orthodontic treatment only and no vibration treatment.

No Vibration Device+Fixed Appliance Tx+Female

Total

Sex: Female, Male

Race and Ethnicity Not Collected

Region of Enrollment

Saliva will be collected as T0 (Baseline), T1 (5-6 weeks), T2 (10-12 weeks), T3 (15-17 weeks). Saliva will be analysed for a variety of biomarkers with protein quantified by ELISA assay at each time point for each subject.

Male and female subjects will randomly assigned to this group to receive fixed appliance orthodontic treatment in conjunction with vibration therapy (daily use of OrthoAccel Aura device for 20 minutes/day) during the study period.
Vibration Device: Subjects receiving the OrthoAccel Aura device will be instructed to use the device for 20 minutes/day per the manufacturer's instructions during the study period.

No Vibration Device+Fixed Appliance Tx

Changes in the Expression of Salivary Biomarkers of Bone Remodeling

At each study visit, alginate impressions will be taken on each subject. These models will be analyzed by 2 examiners to calculate the alignment based on Little's Irregularity Index. Measure Description: Little's Irregularity index measures the interproximal contact displacement in mm between the anterior teeth segment from the mesial of the canine on one side to the mesial aspect of the contralateral canine.

Alignment of Mandibular Anterior Teeth

The degree of tooth mobility will be used using a Periotest device (Siemens, Bensheim, Germany) on the central incisors, canines and 2nd premolars in both mandibular quadrants as previously described by Liou et al. The archwire will be removed and the Periotest measurements will be taken in triplicate, with means recorded. The Periotest's scale ranges from -8 to +50. The lower the Periotest value, the higher is the stability / damping effect of the test object (tooth or implant). -8 to 0 indicates high stability with minimal movement, +1-+9 indicates some degree of mobility (moderate) and +10 to +50 indicates severe mobility.

Tooth Mobility

Subjects will be given a pain diary on the baseline (T0), visits T1 & T2 to record the level of orthodontic pain each evening for the first 7 days after each study visit. The degree of pain was assessed using a metric Visual Analog Scale. The patient was given a scale that was a 100 mm in length. At 0 mm on the scale line, the pain level would be "0" indicating no pain. At the higher end of the line scale (the 100 mm mark), the pain level was considered the most severe. Data presented here indicates the mean VAS scores in mm for the 1st week following each study visit. The average values indicate the measure along the scale.

Orthodontic Pain Assessment

To assess the impact of the vibration appliance on the overall oral health quality of life of the subject, subjects will be given an Oral Health Impact Profile (OHIP-14) questionnaire. The OHIP-14 consists of 14 question areas divided into specific dimensions including functional limitation, physical pain, psychological discomfort, physical disability, psychological and social disability and overall life handicap from orthodontic treatment with or without the vibration appliance. For the OHIP questionnaire, responses are coded 0 (never or not applicable), 1 (hardly ever), 2 (occasionally), 3 (fairly often) or 4 (very often). As a general rule, the greater the OHIP score, the more of an impact a particular intervention had on the patient's overall quality of life. The scores for the overall OHIP-14 range from 0-56, with values closer to 0 indicating minimal impact on quality of life and values closer to 56 indicating great impact on quality of life.

Oral Health Quality of Life

Male and female subjects will randomly assigned to this group to receive fixed appliance orthodontic treatment only. No vibration appliance will be utilized by these patients.

Overall Study

Dr. Flavio Uribe

Tooth Movement

Subjects receiving the OrthoAccel Aura device will be instructed to use the device for 20 minutes/day per the manufacturer's instructions during the study period.

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