Trial Outcomes & Findings for Effect of Cyclic Loading (Vibration) on Orthodontic Tooth Movement (NCT NCT00830947)

Last Updated: 2013-12-23

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

45 participants

Primary outcome timeframe

Time to Space Closure, an average of 22 weeks

Results posted on

2013-12-23

Participant milestones
Measure	OrthoAccel Device OrthoAccel Device : The OA device provides a light vibration at 0.2 Newtons and 30 Hz. frequency for 20 minutes daily.	Sham (Inactive Device) Sham Device : Inactive sham device that is held in the mouth for 20 minutes.
Overall Study STARTED	23	22
Overall Study COMPLETED	19	18
Overall Study NOT COMPLETED	4	4

Reasons for withdrawal
Measure	OrthoAccel Device OrthoAccel Device : The OA device provides a light vibration at 0.2 Newtons and 30 Hz. frequency for 20 minutes daily.	Sham (Inactive Device) Sham Device : Inactive sham device that is held in the mouth for 20 minutes.
Overall Study Lost to Follow-up	4	4

Effect of Cyclic Loading (Vibration) on Orthodontic Tooth Movement

Baseline characteristics by cohort
Measure	OrthoAccel Device n=23 Participants OrthoAccel Device : The OA device provides a light vibration at 0.2 Newtons and 30 Hz. frequency for 20 minutes daily.	Sham (Inactive Device) n=22 Participants Sham Device : Inactive sham device that is held in the mouth for 20 minutes.	Total n=45 Participants Total of all reporting groups
Age Continuous	21.8 years STANDARD_DEVIATION 8.7 • n=5 Participants	21.4 years STANDARD_DEVIATION 7.8 • n=7 Participants	21.6 years STANDARD_DEVIATION 8.2 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	11 Participants n=7 Participants	28 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	11 Participants n=7 Participants	17 Participants n=5 Participants

Timeframe: Time to Space Closure, an average of 22 weeks

Outcome measures
Measure	OrthoAccel Device n=23 Participants OrthoAccel Device : The OA device provides a light vibration at 0.2 Newtons and 30 Hz. frequency for 20 minutes daily.	Sham (Inactive Device) n=22 Participants Sham Device : Inactive sham device that is held in the mouth for 20 minutes.
The Rate of Orthodontic Movement of a Maxillary Canine Tooth Being Distalized to Close an Extraction Space.	0.27 mm/week Standard Deviation 0.04	0.18 mm/week Standard Deviation 0.04

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	OrthoAccel Device n=23 participants at risk OrthoAccel Device : The OA device provides a light vibration at 0.2 Newtons and 30 Hz. frequency for 20 minutes daily.	Sham (Inactive Device) n=22 participants at risk Sham Device : Inactive sham device that is held in the mouth for 20 minutes.
Gastrointestinal disorders Hypoaestesia oral	0.00% 0/23	4.5% 1/22
Gastrointestinal disorders Nausea	4.3% 1/23	0.00% 0/22
Gastrointestinal disorders Retching	0.00% 0/23	4.5% 1/22
Gastrointestinal disorders Toothache	8.7% 2/23	0.00% 0/22
General disorders Malaise	4.3% 1/23	0.00% 0/22
General disorders Sensation of pressure	4.3% 1/23	0.00% 0/22
Injury, poisoning and procedural complications Medical device discomfort	0.00% 0/23	4.5% 1/22
Injury, poisoning and procedural complications Medical device pain	8.7% 2/23	4.5% 1/22
Injury, poisoning and procedural complications TAD Failure	4.3% 1/23	4.5% 1/22
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/23	4.5% 1/22
Nervous system disorders Headache	4.3% 1/23	9.1% 2/22
Nervous system disorders Hypoaesthesia	4.3% 1/23	0.00% 0/22
Respiratory, thoracic and mediastinal disorders Sneezing	4.3% 1/23	0.00% 0/22

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