跳至主要内容
临床试验/NCT05818527
NCT05818527已完成不适用

Effectiveness of Low Frequency Vibration on the Rate of Canine Retraction : A Randomized Controlled Clinical Trial

mohamed abdelmotaleb0 个研究点目标入组 32 人开始时间: 2015年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
32
主要终点
Rate of Canine Retraction in mm Per Month

研究概览

简要总结

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.

详细描述

Introduction:

orthodontic tooth movement(OTM) is a process of mechanically-induced bone modeling where new bone is formed on the tension side and resorbation on the compression side of the periodontal ligament.

One of negative points of orthodontic treatment is long time treatment (24 month ).

Accelerating the speed of orthodontic tooth movement should contribute to the shortening of the treatment period Many approaches was used such as approaches with low-energy laser irradiation and magnetic fields as well as pharmacological approaches with the injection of prostaglandin E2 (PGE2) and However, many side effects, such as local pain, severe root resorption and drug-induced side effects have been reported.

A new device called AcceleDent(OrthoAccel technologies,Inc, USA) has been introduced to the market and aims to achieve an increased rate of tooth movement by enhancing bone remodelling using pulsating forces. Invented by Dr. Jeremy Mao, it is intended to be used by a patient in conjunction with fixed orthodontic appliances or removable sequential aligner treatment for 20 mins per day. It vibrates at a frequency of 30Hz and has force amplitude of 20 grams.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
15 Years 至 21 Years(Child, Adult)
性别
Female
接受健康志愿者
是

入选标准

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

排除标准

  • •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

研究组 & 干预措施

vibrating device arm

Experimental

the patients will use vibrating device 20 mins per day

干预措施: Acceledent vibrating device (Device)

control group

No Intervention

control group using no devices

结局指标

主要结局

Rate of Canine Retraction in mm Per Month

时间窗: 6 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

次要结局

未报告次要终点

研究者

发起方
mohamed abdelmotaleb
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

mohamed abdelmotaleb

principle investigator

Cairo University

相似试验