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临床试验/NCT05814185
NCT05814185已完成不适用

The Effect of Two and Four Activations Per Day of the Periodontal Distractor on Pain Intensity and Pulp Vitality of Maxillary Canine: Randomized Clinical Trial

Al-Azhar University2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2021年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
16
试验地点
2
主要终点
pain intensity

研究概览

简要总结

The aim of the present study was to evaluate the effect of two and four activations /day of periodontal distractor on pain intensity and pulp vitality of maxillary canine.

详细描述

Orthodontic therapy is generally referred to as a lengthy process because a good orthodontic treatment normally takes 18 to 24 months to finish.

Long-term orthodontic treatment has a number of disadvantages, including as poor psychosocial effects on patients, white spots, long-term enamel damage, gingival recession, and root resorption.

The rate of tooth movement that can be achieved is a major determinant of orthodontic treatment time. Many studies have been conducted to determine the pace of orthodontic tooth movement. The majority of these studies demonstrate about 1mm of tooth movement per month.

As a result, finding treatment options that reduce treatment time without compromising results is a main focus of orthodontic research.

The approaches for hastening tooth movement rely on inducing a biological tissue reaction. These procedures are classified into two types based on their level of intrusion: conservative (biological, physical, and biomechanical measures) and surgical techniques Prostaglandins are the most often used biological agents , interleukins , leukotriene , vitamin D platelet rich plasma .Mechanical or physical approach include direct electrical current , pulsed electromagnetic field , low-energy laser , and Vibration Oral surgical procedures quicken orthodontic treatment by affecting the continuity of the alveolar bone resulting in a decrease in bone density and a corresponding reduction in the bone's resistance to orthodontic tooth movement . Surgical approach depends on Regional Acceleratory Phenomenon (RAP) which is a method to speed up orthodontic treatment by accelerating bone remodeling rates and bone density. The RAP is a series of tissue reactions that occur as a damaged bone heals . These surgical methods including corticotomy , bone perforation , Distraction osteogenesis is also one of surgical methods that allow rapid canine retraction .

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
16 Years 至 22 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Orthodontic Patients need extraction of first permanent premolar for orthodontic reasons (dentoalveolar maxillary protrusion, Class II div 1 malocclusion)
  • No history of previous orthodontic treatment
  • Absence of any systemic disease
  • Good oral hygiene and healthy gums look, with no signs of redness, edema, or bleeding during brushing (periodontal inflammation)
  • Highly motivation and cooperation

排除标准

  • Medically compromised patients
  • Use of medication that may affect tooth movement during the period of the study

结局指标

主要结局

pain intensity

时间窗: up to 6 hours on the four activations group and up to 12 hours on two activations group.

evaluation of pain intensity by Visual Analogue scale. minimum 0 and maximum value 10

pulp vitality

时间窗: before and after canine retraction (up to one month)

vitality by Electric pulp tester.positive reading is better

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

Alaa Mossad

Assistant lecturer of orthodontics

Al-Azhar University

研究点 (2)

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