Trial Outcomes & Findings for Effectiveness of Low Frequency Vibration on the Rate of Canine Retraction (NCT NCT05818527)

Last Updated: 2023-08-01

Results Overview

. Retraction of the canine was done using NiTi coil spring delivering a force of 150 gm per side calibrated using digital force gauge, attached between the hook of the canine bracket and the first molar tube on a of 16\*2 stainless steel basal archwire. The intervention group subjects were given AcceleDent devices which delivered gentle micropulses (0.25 N at 30 Hz) and were instructed to wear them every day for 20 mins according to the manufacturer instructions. The patient compliance to intervention instructions were monitored by asking the patient and writing every day on chart how long she used it and compare this with the data download from the appliance that recorded their daily usage during the period of space closure. Follow-up visits were scheduled every four weeks. At each follow up visit, recalibration of the NiTi retraction spring was done using the same force gauge when necessary to maintain 150 gm force delivery. TADs stability and occlusal interferences during canine

Recruitment status

COMPLETED

Study phase

Target enrollment

32 participants

Primary outcome timeframe

6 month

Results posted on

2023-08-01

Participant Flow

Participant milestones

Participant milestones
Measure	Vibrating Device Arm the patients will use vibrating device 20 mins per day Acceledent vibrating device: used to accelerated the movement of teeth during orthodontic treatment	Control Group control group using no devices
Overall Study STARTED	16	16
Overall Study COMPLETED	16	16
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effectiveness of Low Frequency Vibration on the Rate of Canine Retraction

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 6 month

Population: 32 female patients requiring extraction of upper first premolar

Outcome measures

Outcome measures
Measure	Vibrating Device Arm n=16 Participants the patients will use vibrating device 20 mins per day Acceledent vibrating device: used to accelerated the movement of teeth during orthodontic treatment	Control Group n=16 Participants control group using no devices
Rate of Canine Retraction in mm Per Month	5.38 millimeters Standard Deviation 1.2	5.1 millimeters Standard Deviation 1.4

Adverse Events

Vibrating Device Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

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

mohamed atfy abdelmotaleb ( PhD student )

Cairo university

Phone: 01222798922

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Vibrating Device Arm n=16 Participants the patients will use vibrating device 20 mins per day Acceledent vibrating device: used to accelerated the movement of teeth during orthodontic treatment	Control Group n=16 Participants control group using no devices	Total n=32 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants	16 Participants n=7 Participants	32 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	21 years STANDARD_DEVIATION 5.1 • n=5 Participants	17 years STANDARD_DEVIATION 4.1 • n=7 Participants	19 years STANDARD_DEVIATION 1.1 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	16 Participants n=7 Participants	32 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	16 Participants n=5 Participants	16 Participants n=7 Participants	32 Participants n=5 Participants
Region of Enrollment Egypt	16 participants n=5 Participants	16 participants n=7 Participants	32 participants n=5 Participants
canine retraction in millimeter	5.38 millimeters STANDARD_DEVIATION 1.2 • n=5 Participants	5.1 millimeters STANDARD_DEVIATION 1.1 • n=7 Participants	5.28 millimeters STANDARD_DEVIATION 1 • n=5 Participants