Trial Outcomes & Findings for Biomarkers of Orthodontic Tooth Movement With Fixed Appliances and Vibration Appliance Therapy (NCT NCT02119455)
NCT ID: NCT02119455
Last Updated: 2019-12-13
Results Overview
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.
COMPLETED
NA
40 participants
Up to Week 17
2019-12-13
Participant Flow
Participant milestones
| Measure |
Vibration Device+Fixed Appliance Tx
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
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
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Vibration Device+Fixed Appliance Tx
n=20 Participants
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+Female
n=20 Participants
Subjects will randomly assigned to this group to receive fixed appliance orthodontic treatment only and no vibration treatment.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
21.1 years
STANDARD_DEVIATION 5.8 • n=20 Participants
|
19.7 years
STANDARD_DEVIATION 5.5 • n=20 Participants
|
20.4 years
STANDARD_DEVIATION 5.6 • n=40 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=20 Participants
|
10 Participants
n=20 Participants
|
20 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=20 Participants
|
10 Participants
n=20 Participants
|
20 Participants
n=40 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
20 participants
n=20 Participants
|
20 participants
n=20 Participants
|
40 participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Up to Week 17 of alignment (From T0 to T3)Population: Vibration and Control subjects-- all subjects in the study averaged across all time points per group.
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.
Outcome measures
| Measure |
Vibration Device+Fixed Appliance Tx
n=20 Participants
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
n=20 Participants
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.
|
|---|---|---|
|
Changes in the Expression of Salivary Biomarkers of Bone Remodeling
SOST
|
-1.71 pg/mL
Standard Deviation 8.25
|
1.53 pg/mL
Standard Deviation 4.82
|
|
Changes in the Expression of Salivary Biomarkers of Bone Remodeling
RANKL
|
9.28 pg/mL
Standard Deviation 49.59
|
2.59 pg/mL
Standard Deviation 33.46
|
|
Changes in the Expression of Salivary Biomarkers of Bone Remodeling
OPN
|
-371.93 pg/mL
Standard Deviation 1991.37
|
134.44 pg/mL
Standard Deviation 2973.88
|
|
Changes in the Expression of Salivary Biomarkers of Bone Remodeling
IL-18
|
-3.46 pg/mL
Standard Deviation 15.79
|
-0.35 pg/mL
Standard Deviation 4.81
|
|
Changes in the Expression of Salivary Biomarkers of Bone Remodeling
TNFa
|
-1.62 pg/mL
Standard Deviation 8.73
|
0.5 pg/mL
Standard Deviation 13.72
|
|
Changes in the Expression of Salivary Biomarkers of Bone Remodeling
IL-6
|
-1.95 pg/mL
Standard Deviation 8.03
|
0.47 pg/mL
Standard Deviation 11.09
|
|
Changes in the Expression of Salivary Biomarkers of Bone Remodeling
MMP-9
|
-17957.59 pg/mL
Standard Deviation 71966.29
|
6783.71 pg/mL
Standard Deviation 18101.55
|
|
Changes in the Expression of Salivary Biomarkers of Bone Remodeling
IL-3
|
-0.52 pg/mL
Standard Deviation 48.39
|
-1.6 pg/mL
Standard Deviation 22.85
|
|
Changes in the Expression of Salivary Biomarkers of Bone Remodeling
IL-8
|
-35.53 pg/mL
Standard Deviation 175.65
|
-78.66 pg/mL
Standard Deviation 347.4
|
|
Changes in the Expression of Salivary Biomarkers of Bone Remodeling
DKK-1
|
-7.39 pg/mL
Standard Deviation 115.65
|
-14.7 pg/mL
Standard Deviation 62.17
|
|
Changes in the Expression of Salivary Biomarkers of Bone Remodeling
MMP-13
|
-20.27 pg/mL
Standard Deviation 94.22
|
-2.27 pg/mL
Standard Deviation 39.37
|
|
Changes in the Expression of Salivary Biomarkers of Bone Remodeling
IL-11
|
-90.87 pg/mL
Standard Deviation 423.73
|
46.15 pg/mL
Standard Deviation 485.07
|
|
Changes in the Expression of Salivary Biomarkers of Bone Remodeling
OPG
|
-2.69 pg/mL
Standard Deviation 62.90
|
21.05 pg/mL
Standard Deviation 103.62
|
|
Changes in the Expression of Salivary Biomarkers of Bone Remodeling
TGF-B1
|
0.68 pg/mL
Standard Deviation 3.46
|
-9.49 pg/mL
Standard Deviation 36.82
|
PRIMARY outcome
Timeframe: Up to Week 17Population: All subjects (40 total)
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.
Outcome measures
| Measure |
Vibration Device+Fixed Appliance Tx
n=20 Participants
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
n=20 Participants
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.
|
|---|---|---|
|
Alignment of Mandibular Anterior Teeth
|
6.49 mm
Standard Deviation 3.43
|
7.47 mm
Standard Deviation 3.62
|
SECONDARY outcome
Timeframe: Up to Week 17Population: All subjects (40 total).
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.
Outcome measures
| Measure |
Vibration Device+Fixed Appliance Tx
n=20 Participants
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
n=20 Participants
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.
|
|---|---|---|
|
Tooth Mobility
|
2.34 PTV
Standard Deviation 1.10
|
2.42 PTV
Standard Deviation 0.69
|
SECONDARY outcome
Timeframe: Up to Week 17Population: All subjects (40 total).
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.
Outcome measures
| Measure |
Vibration Device+Fixed Appliance Tx
n=20 Participants
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
n=20 Participants
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.
|
|---|---|---|
|
Orthodontic Pain Assessment
T0
|
33.11 mm
Standard Deviation 25.19
|
35.25 mm
Standard Deviation 22.46
|
|
Orthodontic Pain Assessment
T1
|
13.92 mm
Standard Deviation 18.17
|
14.4 mm
Standard Deviation 16.42
|
|
Orthodontic Pain Assessment
T2
|
24.12 mm
Standard Deviation 23.3
|
27.66 mm
Standard Deviation 24.09
|
SECONDARY outcome
Timeframe: Up to Week 17Population: All subjects (40 total).
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.
Outcome measures
| Measure |
Vibration Device+Fixed Appliance Tx
n=20 Participants
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
n=20 Participants
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.
|
|---|---|---|
|
Oral Health Quality of Life
T0
|
4.5 Units on OHIP-14 Scale
Standard Deviation 3.71
|
5.94 Units on OHIP-14 Scale
Standard Deviation 3.74
|
|
Oral Health Quality of Life
T1
|
5.56 Units on OHIP-14 Scale
Standard Deviation 3.73
|
6.12 Units on OHIP-14 Scale
Standard Deviation 3.36
|
|
Oral Health Quality of Life
T2
|
4.4 Units on OHIP-14 Scale
Standard Deviation 3.96
|
4.91 Units on OHIP-14 Scale
Standard Deviation 3.54
|
|
Oral Health Quality of Life
T3
|
3.27 Units on OHIP-14 Scale
Standard Deviation 2.8
|
3.9 Units on OHIP-14 Scale
Standard Deviation 2.79
|
Adverse Events
Vibration Device+Fixed Appliance Tx
No Vibration Device+Fixed Appliance Tx
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Flavio Uribe
University of Connecticut- Division of Orthodontics
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place