THE EFFECT OF VITAMIN C ON POST-ORTHODONTIC TREATMENT RELAPSE: A RANDOMIZED CONTROLLED CLINICAL TRIAL
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Measurement of post-orthodontic relapse
研究概览
简要总结
The aim of this study is to evaluate and compare the effect of locally injected and orally administered (systemic) Vitamin C on post-orthodontic treatment relapse
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 (Investigator)
入排标准
- 年龄范围
- 19 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who were indicated for non-extraction orthodontic treatment.
- •Adult patients with finished orthodontic treatment, using fixed appliance therapy.
- •Patients with good oral hygiene, and a healthy periodontal condition.
排除标准
- •Patients who received sectional fixed appliance therapy.
- •Patients with hypodontia requiring tooth replacement in the retainer, as a temporary measure.
- •Patients requiring fixed bonded retainers.
- •Pregnant and lactating women.
- •Patients with hereditary hemochromatosis.
- •Cancer patients, receiving chemotherapy.
- •Patients with chronic diseases such as diabetes, or those receiving drugs such as corticosteroids, both of which that may affect tooth movement.
研究组 & 干预措施
Intra-epidermal Vitamin C injection
干预措施: Local Vitamin C injection (Biological)
Oral Vit-C supplement
干预措施: Oral Vitamin C supplement (Biological)
Control group
结局指标
主要结局
Measurement of post-orthodontic relapse
时间窗: up to 8 months
Alginate impressions will be taken, and dental models will then be scanned using Sirona inEos X5 CAD/CAM lab scanner, producing 3D digital images of the dental models in the form of stereolithographic (STL) files, which will be subsequently imported into a computer software. Little's Irregularity Index (LII) will be employed for the measurement and the quantitative evaluation of the lower anterior segment alignment. The horizontal linear displacement of the anatomic contact points of each mandibular incisor from the adjacent anatomic point is measured, and the 5 displacements are then summed together. The summed value represents the degree of anterior irregularity as follows: 0 = Perfect alignment. 1-3 = Minimal irregularity. 4-6 = Moderate irregularity. 7-9 = Severe irregularity. 10 = Very severe irregularity.
Analysis of salivary alkaline phosphatase levels
时间窗: up to 8 months
Salivary samples will be collected and measured using chemical analysis. Rise in salivary alkaline phosphatase levels reflects inflammation and destruction of healthy tissues suggesting it as a clinical biomarker. The normal level of alkaline phosphatase is 20-140IU/L (international unit per liter) in adults.
次要结局
未报告次要终点
研究者
Nourhan M.Aly
Assistant Lecturer of Dental Public Health
University of Alexandria