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临床试验/NCT02891499
NCT02891499已完成不适用

Effect of Low-level Laser Therapy on Stability and Displacement of Orthodontic Miniscrew Implants With Mediate and Immediate Force Application

University of Sao Paulo0 个研究点目标入组 29 人开始时间: 2016年3月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
29
主要终点
Change from baseline miniscrew implant stability at 1 and 3 months of force application.

研究概览

简要总结

The purpose of this study is to evaluate the effect of Low level laser therapy on stability and displacement of orthodontic miniscrew implants using two different force application protocols.

详细描述

The aim of this study is to evaluate the effect of Low level laser therapy (LLLT) on stability and displacement of orthodontic miniscrew implants with mediate and immediate force application. They will be assessed 48 miniscrew implants placed in patients in orthodontic treatment at the postgraduate clinical in Orthodontics, at School of Dentistry of Ribeirão Preto, University of São Paulo. They will be randomly divided into 4 groups: 1- LLLT and immediate force application; 2- LLLT and force application 4 weeks after implantation; 3- immediate force application without LLLT and 4- force application 4 weeks after implantation without LLLT. Orthodontic force of 150 gF will be applied for 3 months. A low power laser device Therapy XT with a wavelength of 660 nm and output of 100 mW immediately after implantation (energy density: 4J/cm2), and 808 nm with 100 mW (energy density: 8J/cm2), every 48 hours for two weeks in the following applications will be used. The stability will be assessed using Resonance Frequency Analysis (RFA) at three times: the implantation day (T1), one month (T2) and after 3 months of force application (T3). Stability measures will be evaluated in Implant Stability Quotient (ISQ). To assess the amount of miniscrew implant displacement, it will be used Cone Beam Computed Tomography (CBCT) at the beginning (CT1) and final of the application of orthodontic force (CT2). Three-dimensional models will be created in specific programs and superimpositions of CT1 and CT2 will be used to measure the distance in millimeters between inicial and final position. The evaluation will be carried out in three points: head of miniscrew implant (point C), thread (point R) and apex of miniscrew implant (point A). The results will be statistically analyzed according to nature of the data and the significance level to be adopted will be 5%.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
11 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient with permanent teeth.
  • Use of miniscrews in orthodontic planning.
  • Miniscrews placed in the labial upper and lower posterior regions.
  • Patient who agree to participate (Informed consent)

排除标准

  • Patient with systemic disease.
  • Patient with periodontal disease and/or inadequate oral hygiene.
  • Use of drugs chronically.
  • Patients that consume alcohol or tobacco.
  • Use of fixed palatal or lingual orthodontic devices.

研究组 & 干预措施

LLLT + immediate force

Experimental

Use of Low-level laser therapy and not mediate orthodontic force application (150 gF the day of the implantation).

干预措施: Low-level laser therapy (Procedure)

LLLT + mediate force

Experimental

Use of Low-level laser therapy and mediate orthodontic force application (150 gF 4 weeks after the day of the implantation).

干预措施: Low-level laser therapy (Procedure)

LLLT + mediate force

Experimental

Use of Low-level laser therapy and mediate orthodontic force application (150 gF 4 weeks after the day of the implantation).

干预措施: Mediate force application (Procedure)

Immediate force application

No Intervention

Not mediate orthodontic force application (150 gF the day of the implantation), without use of Low-level laser therapy.

Mediate force application

Experimental

Mediate orthodontic force application (150 gF 4 weeks after the day of the implantation), without use of Low-level laser therapy.

干预措施: Mediate force application (Procedure)

结局指标

主要结局

Change from baseline miniscrew implant stability at 1 and 3 months of force application.

时间窗: T1: Implantation day; T2: after 1 month; and, T3: after 3 months of force application.

It will be used a Resonance frequency analysis (RFA) equipment. Stability measures will be evaluated using a unique unit of measure: Implant stability quotient (ISQ). All groups will be evaluated the day of the implantation (T1) and after 1 month (T2).The last stability measure (T3) will be done 3 months after the implantation day in the groups without mediate force application, and 4 months after the implantation day in the groups with mediate force application.

Change from baseline miniscrew implant position at 3 months of force application.

时间窗: CT1: Implantation day; and, CT2: 3 months of orthodontic force application.

It will be used Cone Beam Computed tomography (CBCT). Three-dimensional models will be created in specific programs and superimpositions of CT1 and CT2 will be used to measure the distance in millimeters between initial and final position.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Guido Artemio Marañón Vásquez

Master of science student

University of Sao Paulo

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