Trial Outcomes & Findings for Accelerated Invisalign Therapy in Conjunction With Acceledent Aura (NCT NCT02868554)
NCT ID: NCT02868554
Last Updated: 2020-01-27
Results Overview
Little's Irregularity Index is the sum of contact displacement in mm between the anterior teeth from mesial of one canine to the mesial of the contralateral canine.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
34 participants
Primary outcome timeframe
Baseline (Week 0)
Results posted on
2020-01-27
Participant Flow
Participant milestones
| Measure |
Standard Invisalign Therapy
Patients receiving standard Invisalign therapy will be instructed to wear each aligner 24 hours day. Patients will be permitted to progress to the subsequent aligner after 14 days of compliant aligner wear.
|
Accelerated Invisalign
Patients receiving accelerated Invisalign therapy will be instructed to wear each aligner 24 hours day. Patients will be permitted to progress to the subsequent aligner after 4 days of compliant aligner wear.
Accelerated Invisalign therapy: Patients receiving accelerated Invisalign therapy will be instructed to wear each aligner 24 hours day. Patients will be permitted to progress to the subsequent aligner after 4 days of compliant aligner wear.
|
Accelerated Invisalign and Vibration
In addition to the accelerated Invisalign protocol described in Arm #2, patients will undergo intraoral vibration therapy using an AcceleDent Aura device for a duration of 20 minutes per day.
AcceleDent Aura: Patients receiving vibration therapy will be instructed to bite down on the AcceleDent mouthpiece, which vibrates at a .25 Newtons (25 grams) force level with a 30 Hertz frequency for 20 minutes per day.
Accelerated Invisalign therapy: Patients receiving accelerated Invisalign therapy will be instructed to wear each aligner 24 hours day. Patients will be permitted to progress to the subsequent aligner after 4 days of compliant aligner wear.
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
12
|
12
|
|
Overall Study
COMPLETED
|
7
|
12
|
11
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
1
|
Reasons for withdrawal
| Measure |
Standard Invisalign Therapy
Patients receiving standard Invisalign therapy will be instructed to wear each aligner 24 hours day. Patients will be permitted to progress to the subsequent aligner after 14 days of compliant aligner wear.
|
Accelerated Invisalign
Patients receiving accelerated Invisalign therapy will be instructed to wear each aligner 24 hours day. Patients will be permitted to progress to the subsequent aligner after 4 days of compliant aligner wear.
Accelerated Invisalign therapy: Patients receiving accelerated Invisalign therapy will be instructed to wear each aligner 24 hours day. Patients will be permitted to progress to the subsequent aligner after 4 days of compliant aligner wear.
|
Accelerated Invisalign and Vibration
In addition to the accelerated Invisalign protocol described in Arm #2, patients will undergo intraoral vibration therapy using an AcceleDent Aura device for a duration of 20 minutes per day.
AcceleDent Aura: Patients receiving vibration therapy will be instructed to bite down on the AcceleDent mouthpiece, which vibrates at a .25 Newtons (25 grams) force level with a 30 Hertz frequency for 20 minutes per day.
Accelerated Invisalign therapy: Patients receiving accelerated Invisalign therapy will be instructed to wear each aligner 24 hours day. Patients will be permitted to progress to the subsequent aligner after 4 days of compliant aligner wear.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Standard Invisalign Therapy
n=10 Participants
Patients receiving standard Invisalign therapy will be instructed to wear each aligner 24 hours day. Patients will be permitted to progress to the subsequent aligner after 14 days of compliant aligner wear.
|
Accelerated Invisalign
n=12 Participants
Patients receiving accelerated Invisalign therapy will be instructed to wear each aligner 24 hours day. Patients will be permitted to progress to the subsequent aligner after 4 days of compliant aligner wear.
Accelerated Invisalign therapy: Patients receiving accelerated Invisalign therapy will be instructed to wear each aligner 24 hours day. Patients will be permitted to progress to the subsequent aligner after 4 days of compliant aligner wear.
|
Accelerated Invisalign and Vibration
n=11 Participants
In addition to the accelerated Invisalign protocol described in Arm #2, patients will undergo intraoral vibration therapy using an AcceleDent Aura device for a duration of 20 minutes per day.
AcceleDent Aura: Patients receiving vibration therapy will be instructed to bite down on the AcceleDent mouthpiece, which vibrates at a .25 Newtons (25 grams) force level with a 30 Hertz frequency for 20 minutes per day.
Accelerated Invisalign therapy: Patients receiving accelerated Invisalign therapy will be instructed to wear each aligner 24 hours day. Patients will be permitted to progress to the subsequent aligner after 4 days of compliant aligner wear.
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
36.9 years
STANDARD_DEVIATION 13.5 • n=10 Participants
|
31.3 years
STANDARD_DEVIATION 9.1 • n=12 Participants
|
31.1 years
STANDARD_DEVIATION 8.5 • n=11 Participants
|
32.9 years
STANDARD_DEVIATION 10.6 • n=33 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=10 Participants
|
9 Participants
n=12 Participants
|
7 Participants
n=11 Participants
|
21 Participants
n=33 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=10 Participants
|
3 Participants
n=12 Participants
|
4 Participants
n=11 Participants
|
12 Participants
n=33 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
10 Participants
n=10 Participants
|
12 Participants
n=12 Participants
|
11 Participants
n=11 Participants
|
33 Participants
n=33 Participants
|
PRIMARY outcome
Timeframe: Baseline (Week 0)Little's Irregularity Index is the sum of contact displacement in mm between the anterior teeth from mesial of one canine to the mesial of the contralateral canine.
Outcome measures
| Measure |
Standard Invisalign Therapy
n=7 Participants
Patients receiving standard Invisalign therapy will be instructed to wear each aligner 24 hours day. Patients will be permitted to progress to the subsequent aligner after 14 days of compliant aligner wear.
|
Accelerated Invisalign
n=12 Participants
Patients receiving accelerated Invisalign therapy will be instructed to wear each aligner 24 hours day. Patients will be permitted to progress to the subsequent aligner after 4 days of compliant aligner wear.
Accelerated Invisalign therapy: Patients receiving accelerated Invisalign therapy will be instructed to wear each aligner 24 hours day. Patients will be permitted to progress to the subsequent aligner after 4 days of compliant aligner wear.
|
Accelerated Invisalign and Vibration
n=11 Participants
In addition to the accelerated Invisalign protocol described in Arm #2, patients will undergo intraoral vibration therapy using an AcceleDent Aura device for a duration of 20 minutes per day.
AcceleDent Aura: Patients receiving vibration therapy will be instructed to bite down on the AcceleDent mouthpiece, which vibrates at a .25 Newtons (25 grams) force level with a 30 Hertz frequency for 20 minutes per day.
Accelerated Invisalign therapy: Patients receiving accelerated Invisalign therapy will be instructed to wear each aligner 24 hours day. Patients will be permitted to progress to the subsequent aligner after 4 days of compliant aligner wear.
|
|---|---|---|---|
|
Little's Irregularity Index (LI) at Baseline
|
6.11 mm
Standard Deviation 1.24
|
6.31 mm
Standard Deviation 2.71
|
6.89 mm
Standard Deviation 2.24
|
PRIMARY outcome
Timeframe: End of Study (a total of approximately 12 weeks)Little's Irregularity Index is the sum of contact displacement in mm between the anterior teeth from mesial of one canine to the mesial of the contralateral canine.
Outcome measures
| Measure |
Standard Invisalign Therapy
n=7 Participants
Patients receiving standard Invisalign therapy will be instructed to wear each aligner 24 hours day. Patients will be permitted to progress to the subsequent aligner after 14 days of compliant aligner wear.
|
Accelerated Invisalign
n=12 Participants
Patients receiving accelerated Invisalign therapy will be instructed to wear each aligner 24 hours day. Patients will be permitted to progress to the subsequent aligner after 4 days of compliant aligner wear.
Accelerated Invisalign therapy: Patients receiving accelerated Invisalign therapy will be instructed to wear each aligner 24 hours day. Patients will be permitted to progress to the subsequent aligner after 4 days of compliant aligner wear.
|
Accelerated Invisalign and Vibration
n=11 Participants
In addition to the accelerated Invisalign protocol described in Arm #2, patients will undergo intraoral vibration therapy using an AcceleDent Aura device for a duration of 20 minutes per day.
AcceleDent Aura: Patients receiving vibration therapy will be instructed to bite down on the AcceleDent mouthpiece, which vibrates at a .25 Newtons (25 grams) force level with a 30 Hertz frequency for 20 minutes per day.
Accelerated Invisalign therapy: Patients receiving accelerated Invisalign therapy will be instructed to wear each aligner 24 hours day. Patients will be permitted to progress to the subsequent aligner after 4 days of compliant aligner wear.
|
|---|---|---|---|
|
Little's Irregularity Index at Final Stage
|
4.97 mm
Standard Deviation 1.21
|
3.07 mm
Standard Deviation 2.59
|
4.52 mm
Standard Deviation 1.61
|
PRIMARY outcome
Timeframe: Baseline, 12 weeksThe rate of orthodontic tooth movement (Little's Irregularity Index mm/day) will be evaluated. Little's Irregularity Index is the sum of contact displacement in mm between the anterior teeth from mesial of one canine to the mesial of the contralateral canine.
Outcome measures
| Measure |
Standard Invisalign Therapy
n=7 Participants
Patients receiving standard Invisalign therapy will be instructed to wear each aligner 24 hours day. Patients will be permitted to progress to the subsequent aligner after 14 days of compliant aligner wear.
|
Accelerated Invisalign
n=12 Participants
Patients receiving accelerated Invisalign therapy will be instructed to wear each aligner 24 hours day. Patients will be permitted to progress to the subsequent aligner after 4 days of compliant aligner wear.
Accelerated Invisalign therapy: Patients receiving accelerated Invisalign therapy will be instructed to wear each aligner 24 hours day. Patients will be permitted to progress to the subsequent aligner after 4 days of compliant aligner wear.
|
Accelerated Invisalign and Vibration
n=11 Participants
In addition to the accelerated Invisalign protocol described in Arm #2, patients will undergo intraoral vibration therapy using an AcceleDent Aura device for a duration of 20 minutes per day.
AcceleDent Aura: Patients receiving vibration therapy will be instructed to bite down on the AcceleDent mouthpiece, which vibrates at a .25 Newtons (25 grams) force level with a 30 Hertz frequency for 20 minutes per day.
Accelerated Invisalign therapy: Patients receiving accelerated Invisalign therapy will be instructed to wear each aligner 24 hours day. Patients will be permitted to progress to the subsequent aligner after 4 days of compliant aligner wear.
|
|---|---|---|---|
|
Rate of Orthodontic Tooth Movement [Difference in Little's Irregularity Index, mm/Day]
|
0.0136 mm/day
Standard Deviation 0.0057
|
0.0202 mm/day
Standard Deviation 0.0135
|
0.0243 mm/day
Standard Deviation 0.0163
|
PRIMARY outcome
Timeframe: Baseline, 12 weeksThe percent change in the irregularity index between the baseline and the final will be evaluated. Little's Irregularity Index is the sum of contact displacement in mm between the anterior teeth from mesial of one canine to the mesial of the contralateral canine.
Outcome measures
| Measure |
Standard Invisalign Therapy
n=7 Participants
Patients receiving standard Invisalign therapy will be instructed to wear each aligner 24 hours day. Patients will be permitted to progress to the subsequent aligner after 14 days of compliant aligner wear.
|
Accelerated Invisalign
n=12 Participants
Patients receiving accelerated Invisalign therapy will be instructed to wear each aligner 24 hours day. Patients will be permitted to progress to the subsequent aligner after 4 days of compliant aligner wear.
Accelerated Invisalign therapy: Patients receiving accelerated Invisalign therapy will be instructed to wear each aligner 24 hours day. Patients will be permitted to progress to the subsequent aligner after 4 days of compliant aligner wear.
|
Accelerated Invisalign and Vibration
n=11 Participants
In addition to the accelerated Invisalign protocol described in Arm #2, patients will undergo intraoral vibration therapy using an AcceleDent Aura device for a duration of 20 minutes per day.
AcceleDent Aura: Patients receiving vibration therapy will be instructed to bite down on the AcceleDent mouthpiece, which vibrates at a .25 Newtons (25 grams) force level with a 30 Hertz frequency for 20 minutes per day.
Accelerated Invisalign therapy: Patients receiving accelerated Invisalign therapy will be instructed to wear each aligner 24 hours day. Patients will be permitted to progress to the subsequent aligner after 4 days of compliant aligner wear.
|
|---|---|---|---|
|
Rate of Orthodontic Tooth Movement [Total % Change of Little's Irregularity Index]
|
18.90 percent change in LI
Standard Deviation 7.65
|
23.71 percent change in LI
Standard Deviation 11.02
|
29.12 percent change in LI
Standard Deviation 10.77
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Due to loss of key study personnel these data were not collected
Gingival crevicular fluid will be sampled to determine if vibratory stimulation during orthodontic tooth movement increases the activity of the Receptor Activator of Nuclear Factor-KappaB (RANK), Receptor Activator of Nuclear Factor-KappaB Ligand (RANKL) and Osteoprotegerin (OPG) cell signaling pathway.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 12Research subjects asked to complete questionaire at Week 12 in order to determine what effect vibratory stimulation has on discomfort during orthodontic treatment. The FACES Pain Visual Analog Pain Scale was used to assess pain. Pain was assessed on a 0 (no pain) to 10 (worst pain) grading scale. Lower scores reflect lower pain levels.
Outcome measures
| Measure |
Standard Invisalign Therapy
n=7 Participants
Patients receiving standard Invisalign therapy will be instructed to wear each aligner 24 hours day. Patients will be permitted to progress to the subsequent aligner after 14 days of compliant aligner wear.
|
Accelerated Invisalign
n=12 Participants
Patients receiving accelerated Invisalign therapy will be instructed to wear each aligner 24 hours day. Patients will be permitted to progress to the subsequent aligner after 4 days of compliant aligner wear.
Accelerated Invisalign therapy: Patients receiving accelerated Invisalign therapy will be instructed to wear each aligner 24 hours day. Patients will be permitted to progress to the subsequent aligner after 4 days of compliant aligner wear.
|
Accelerated Invisalign and Vibration
n=11 Participants
In addition to the accelerated Invisalign protocol described in Arm #2, patients will undergo intraoral vibration therapy using an AcceleDent Aura device for a duration of 20 minutes per day.
AcceleDent Aura: Patients receiving vibration therapy will be instructed to bite down on the AcceleDent mouthpiece, which vibrates at a .25 Newtons (25 grams) force level with a 30 Hertz frequency for 20 minutes per day.
Accelerated Invisalign therapy: Patients receiving accelerated Invisalign therapy will be instructed to wear each aligner 24 hours day. Patients will be permitted to progress to the subsequent aligner after 4 days of compliant aligner wear.
|
|---|---|---|---|
|
Mean Patient Discomfort Score
|
0.643 score on a scale
Standard Deviation 0.945
|
1.583 score on a scale
Standard Deviation 1.379
|
0.682 score on a scale
Standard Deviation 1.230
|
Adverse Events
Standard Invisalign Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Accelerated Invisalign
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Accelerated Invisalign and Vibration
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Ching-Chang Ko, DDS, PhD
University of North Carolina at Chapel Hill
Phone: 919-537-3763
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place