Effectiveness of Low Frequency Vibration on the Rate of Canine Retraction

NCT05818527 | Completed Results DMC FDA Device

• 1 other identifier: tooth acceleration
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this Randomized controlled clinical trial is To investigate the effectiveness of AcceleDent Aura vibrating device on rate of canine retraction in orthodontic treatment.. The main question\[s\] it aims to answer are: • 1st question In Patients with class II requiring canine retraction it possible to accelerate canine retraction safely using AcceleDent? 2nd question: is accelerating teeth movement effect root condition ? the study will be done on Orthodontic patients with class II requiring canine retraction Excluding Any dental or medical disease affecting tooth movement.

Conditions

Orthodontic Appliance Complication

Outcome Measures

Primary Outcomes (1)

• Rate of Canine Retraction in mm Per Month

  . 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

  6 month

Study Arms (2)

vibrating device arm

EXPERIMENTAL

the patients will use vibrating device 20 mins per day

Device: Acceledent vibrating device

control group

NO INTERVENTION

control group using no devices

Interventions

Acceledent vibrating device DEVICE

used to accelerated the movement of teeth during orthodontic treatment

vibrating device arm

Eligibility Criteria

• Age: 15 Years - 21 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Full permanent dentition. Good general and oral health. Severe crowding or protrusion requiring first premolars extractions

You may not qualify if:

• Systemic disease or syndrome.
• Abnormalities in teeth size and/or shape.
• Vertical, transverse or antero-posterior skeletal discrepancies.
• History of previous orthodontic treatment.
• Anti-inflammatory medication

Sponsors & Collaborators

• mohamed abdelmotaleb: lead
• Cairo University: collaborator

Related Publications (2)

• Kalajzic Z, Peluso EB, Utreja A, Dyment N, Nihara J, Xu M, Chen J, Uribe F, Wadhwa S. Effect of cyclical forces on the periodontal ligament and alveolar bone remodeling during orthodontic tooth movement. Angle Orthod. 2014 Mar;84(2):297-303. doi: 10.2319/032213-234.1. Epub 2013 Aug 12.

  PMID: 23937517 BACKGROUND

• Miles P, Smith H, Weyant R, Rinchuse DJ. The effects of a vibrational appliance on tooth movement and patient discomfort: a prospective randomised clinical trial. Aust Orthod J. 2012 Nov;28(2):213-8.

  PMID: 23304970 BACKGROUND

Results Point of Contact

• Title: mohamed atfy abdelmotaleb ( PhD student )
• Organization: Cairo university

atfy2002@yahoo.com

01222798922

Study Officials

• Amr R Elbialy, professor

  Cairo University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: February 28, 2023
• First Posted: April 19, 2023
• Study Start: September 1, 2015
• Primary Completion: April 1, 2017
• Study Completion: September 1, 2017
• Last Updated: August 1, 2023
• Results First Posted: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share