A Comparative Assessment of Post Extraction Pain in Orthodontic Patients to Evaluate the Effects of Early Engagement of Tooth with Orthodontic Wires. a Single Center Randomized Clinical Trial (RCT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- A comparative assessment of post extraction pain in orthodontic patients to evaluate the effects of early engagement of tooth with orthodontic wires.
研究概览
简要总结
The goal of this clinical trial is to determine if the timing of tooth extractions (before or after initial orthodontic treatment) affects pain levels in patients who need bilateral extractions of first premolars in the upper jaw. The participants in this study are patients who require these extractions as part of their orthodontic treatment.
The main questions it aims to answer are:
- Does extracting teeth before starting orthodontic treatment result in different pain levels compared to extracting teeth after alignment?
- How do pain levels change over time after the extractions in each group?
Researchers will compare Group A (patients who have extractions before orthodontic treatment) to Group B (patients who have extractions after initial alignment) to see if the timing of the extractions affects pain levels.
Participants will:
Undergo tooth extractions either before or after initial alignment based on their group.
Rate their pain on an 11-point numerical rating scale at various times (2, 4, 8, 12, and 24 hours after extraction, and then daily for a week).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •12 to 18-year-old orthodontic patients needing bilaterally symmetrical extractions of first premolars as a part of orthodontic treatment. Angles class I with moderate to severe crowding cases, bimaxillary proclination, and Angles class II division 1 were included.
排除标准
- •Patients with poor oral hygiene, carious or missing premolars, multiple missing teeth, systemic diseases, periodontitis or patients on analgesics (NSAIDs, and corticosteroids) were excluded from the study.
结局指标
主要结局
A comparative assessment of post extraction pain in orthodontic patients to evaluate the effects of early engagement of tooth with orthodontic wires.
时间窗: 2.6 years
In this randomized clinical trial, 44 patients were recruited who needed bilateral extractions of first premolars in upper arches. Patients were divided into two groups based on the timing of extractions. Group A needed extractions before alignment while Group B needed extractions for retraction of anterior teeth. Group A was sent for extractions first while Group B went for orthodontic bonding and banding procedures for orthodontic treatment. After series of aligning wires (0.014, 0.016, 17x25, 19x25 Heat activated NiTi and 19x25 SS) patients from group B were sent for extractions. For pain assessment, an 11-point numerical rating scale (NRS) were given to record pain intensity at 2, 4, 8, 12 and then 24 hours after extraction for the next 7 days.
次要结局
未报告次要终点
研究者
Meenaz Karim
Dr.
Universiti Sains Malaysia