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Trial Outcomes & Findings for Accelerated Tooth Movement With AcceleDent® and Aligners - a Pilot Project (NCT NCT02438280)

NCT ID: NCT02438280

Last Updated: 2018-10-30

Results Overview

The outcome was the ability to complete the initial set of aligners using either an active vibration device or a placebo vibration device. Regardless of the group assignment, patients were asked to change their aligners each week, and we tracked the percentage that were able to complete their series of aligners.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

27 participants

Primary outcome timeframe

6 months

Results posted on

2018-10-30

Participant Flow

Participant milestones

Participant milestones
Measure
A (Active Device)
20 minutes daily usage in conjunction with orthodontic treatment with clear aligners AcceleDent, Vibrational Device: Participants will receive one of two vibrational units This groups received Active Devices with frequency of 30Hz ( revealed after study completion )
B (Control Device)
20 minutes daily usage in conjunction with orthodontic treatment with clear aligners AcceleDent, Vibrational Device: Participants will receive one of two vibrational units This group received control devices with frequency of 0 Hz ( revealed after study completion )
Overall Study
STARTED
14
13
Overall Study
COMPLETED
13
13
Overall Study
NOT COMPLETED
1
0

Reasons for withdrawal

Reasons for withdrawal
Measure
A (Active Device)
20 minutes daily usage in conjunction with orthodontic treatment with clear aligners AcceleDent, Vibrational Device: Participants will receive one of two vibrational units This groups received Active Devices with frequency of 30Hz ( revealed after study completion )
B (Control Device)
20 minutes daily usage in conjunction with orthodontic treatment with clear aligners AcceleDent, Vibrational Device: Participants will receive one of two vibrational units This group received control devices with frequency of 0 Hz ( revealed after study completion )
Overall Study
Physician Decision
1
0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
A (Active Device)
n=14 Participants
20 minutes daily usage in conjunction with orthodontic treatment with clear aligners AcceleDent, Vibrational Device: Participants will receive one of two vibrational units
B (Control Device)
n=13 Participants
20 minutes daily usage in conjunction with orthodontic treatment with clear aligners AcceleDent, Vibrational Device: Participants will receive one of two vibrational units
Total
n=27 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=14 Participants
0 Participants
n=13 Participants
0 Participants
n=27 Participants
Age, Categorical
Between 18 and 65 years
14 Participants
n=14 Participants
13 Participants
n=13 Participants
27 Participants
n=27 Participants
Age, Categorical
>=65 years
0 Participants
n=14 Participants
0 Participants
n=13 Participants
0 Participants
n=27 Participants
Sex: Female, Male
Female
8 Participants
n=14 Participants
7 Participants
n=13 Participants
15 Participants
n=27 Participants
Sex: Female, Male
Male
6 Participants
n=14 Participants
6 Participants
n=13 Participants
12 Participants
n=27 Participants
Race and Ethnicity Not Collected
—
—
0 Participants
Race and Ethnicity were not collected from any participant.
Region of Enrollment
Canada
8 participants
n=14 Participants
3 participants
n=13 Participants
11 participants
n=27 Participants
Region of Enrollment
United States
6 participants
n=14 Participants
10 participants
n=13 Participants
16 participants
n=27 Participants

PRIMARY outcome

Timeframe: 6 months

Population: The outcome was the ability to complete the initial set of aligners

The outcome was the ability to complete the initial set of aligners using either an active vibration device or a placebo vibration device. Regardless of the group assignment, patients were asked to change their aligners each week, and we tracked the percentage that were able to complete their series of aligners.

Outcome measures

Outcome measures
Measure
A (Active Device)
n=13 Participants
20 minutes daily usage of an active vibration device
B (Control Device)
n=13 Participants
20 minutes daily usage of a placebo vibration device
Ability to Complete Treatment Aligners in Conjunction With an Active and Placebo Vibration Device (AcceleDent® Aura)
10 Participants
11 Participants

SECONDARY outcome

Timeframe: 6 months

Population: Final incisor irregularity, measured in millimeters

Final alignment was measured using Little's incisor irregularity index. This index sums the displacement of the contact points of the anterior teeth, to produce a millimetric number. The lower the score, the more perfect the alignment.

Outcome measures

Outcome measures
Measure
A (Active Device)
n=13 Participants
20 minutes daily usage of an active vibration device
B (Control Device)
n=13 Participants
20 minutes daily usage of a placebo vibration device
Final Alignment Scores of the Upper and Lower Incisors
2.2 Little's irregularity index (mm)
Standard Deviation .92
2.1 Little's irregularity index (mm)
Standard Deviation .54

Adverse Events

A (Active Device)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

B (Control Device)

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

Dr. Greg Huang, Professor and Chair of Orthodontics

University of Washington

Phone: (206) 616-6996

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place