跳至主要内容
临床试验/NCT05250921
NCT05250921已完成不适用

The Effect of Corticision on Perceived Pain and Discomfort for Patients With Crowded Lower Anterior Teeth in Young Adult Patients: Randomized Clinical Trial

Damascus University1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2019年3月9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
52
试验地点
1
主要终点
Change in the levels of swelling

研究概览

简要总结

The duration of orthodontic treatment is one of the exacerbation causes of orthodontic pain. Several methods have been suggested to reduce the duration of orthodontic treatment classified to surgical and non-surgical methods.

Researches used minimally invasive surgical methods like corticision, piezocesion, disicion, micro-osteoperforation, and piezopuncture indicated that most of these methods can accelerate dental movement by 20 - 40% without causing additional pain as a result of using those methods.

Applying corticision on the lower anterior teeth using a surgical blade and a hammer may accelerate tooth alignment during orthodontic treatment. This study consists of two groups, patients will be randomly assigned to one of these two groups.

详细描述

Pain is defined as an unpleasant emotional sensory experience associated with actual or potential harm. It was mentioned as one of the most common complaints related to orthodontic treatment, and around 65-95% of patients undergoing orthodontic treatment suffer from various degrees of pain.

Corticision is one of the minimally invasive surgical procedures that is not associated with flap lifting. It was used to accelerate tooth movement in animals and case report studies. Its application on humans may aggravate their fear and anxiety towards the pain that may accompany this technique.

No study in the literature has been searched in patient perception of pain, discomfort, levels of acceptance and satisfaction accompanied corticision application application, but in this study, these previous variables accompanied corticision technique have been studied on crowded lower anterior teeth cases which are one of the most common types of malocclusions.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 24 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age range between 18 and 24 years
  • Completion of permanent dentition (except third molars)
  • Mild to moderate crowding (2-6 mm according to Little's index)
  • Absence of medications intake that interferes with pain perception for at least one week before the beginning of the treatment

排除标准

  • Systematic diseases that could affect bone and tooth movement and no contraindication avoid oral surgery
  • Medical conditions that affect tooth movement (Corticosteroid, NSAIDs)
  • Patients had previous orthodontic treatments
  • Poor oral hygiene or concurrent periodontal disease

结局指标

主要结局

Change in the levels of swelling

时间窗: at 1, 7, 14 days following the onset of orthodontic treatment

swelling is assessed by asking the study participant to place a mark on a horizontal 100 mm line to indicate the level of swelling being experienced. The left end of the line refers to no swelling (VAS=0) where the right end refers to maximum swelling (VAS=100). The level of swelling is represented in the number of millimeters measured from the left end of the line to the mark pointed out by the patient. This is called the Visual Analogue Score (VAS) where the higher the number is the more intense the swelling.

Change in the levels of discomfort:

时间窗: at 1, 7, 14 days following the onset of orthodontic treatment

discomfort is assessed by asking the study participant to place a mark on a horizontal 100 mm line to indicate the level of discomfort being experienced. The left end of the line refers to no discomfort (VAS=0) where the right end refers to maximum discomfort (VAS=100). The level of discomfort is represented in the number of millimeters measured from the left end of the line to the mark pointed out by the patient. This is called the Visual Analogue Score (VAS) where the higher the number is the more intense the discomfort.

Change in the levels of pain

时间窗: at 1, 7, 14 days following the onset of orthodontic treatment

Pain is assessed by asking the study participant to place a mark on a horizontal 100 mm line to indicate the level of pain being experienced. The left end of the line refers to no pain (VAS=0) where the right end refers to maximum (unimaginable) pain (VAS=100). The level of pain is represented in the number of millimeters measured from the left end of the line to the mark pointed out by the patient. This is called the Visual Analogue Score (VAS) where the higher the number is the more intense the pain.

Change in the perception of mastication problems:

时间窗: at 1, 7, 14 days following the onset of orthodontic treatment

difficulties of mastication are assessed by asking the study participant to place a mark on a horizontal 100 mm line to indicate the level of difficulties in mastication being experienced. The left end of the line refers to no difficulties (VAS=0) where the right end refers to maximum difficulties (VAS=100). The level of difficulties in mastication are represented in the number of millimeters measured from the left end of the line to the mark pointed out by the patient. This is called the Visual Analogue Score (VAS) where the higher the number is the more intense the difficulties of mastication.

Number of analgesic tables taken

时间窗: at seven days following the onset of orthodontic treatment

The number of tablets used: Patients in both groups were asked about taking analgesics and their quantity (mg) They answered about taking analgesics using a two-point scale (1. Yes or 2. No), and their quantity by mentioning how many tablets they took.

次要结局

  • Satisfaction through recommending the procedure(At the end of leveling and alignment)
  • Satisfaction with the ease of the procedure(At the end of leveling and alignment)
  • Satisfaction through acceptability of the procedure(At the end of leveling and alignment)
  • Satisfaction using VAS:(At the end of leveling and alignment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验