Clinical Evaluation of Local Calcitriol Delivery on Maxillary Canine Retraction
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 22
- 主要终点
- Amount of maxillary canine retraction (mm) assessed on CBCT scans
研究概览
简要总结
This study will evaluate the effect of locally applied Calcitriol on dental and skeletal changes during upper canine retraction. It is a split-mouth randomized clinical trial, where Calcitriol will be locally applied on one side of the maxilla, and the other side will serve as control.
详细描述
Orthodontic tooth movement depends on bone remodeling. This study investigates if Calcitriol, the active form of vitamin D3, can affect this process when applied locally during upper canine retraction. The study is designed as a split-mouth randomized clinical trial. Patients needing maxillary first premolar extraction will be included. Calcitriol will be locally applied on one side, and the other will serve as a control. The study will evaluate dental and skeletal changes to see if Calcitriol improves treatment outcomes.
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
- None
入排标准
- 年龄范围
- 13 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Presence of class I malocclusion requiring bilateral extraction of the maxillary first premolars and subsequent canine retraction.
- •Presence of class II malocclusion requiring bilateral extraction of the maxillary first premolars and subsequent canine retraction.
- •Age range between 13 and 35 years to include both adolescent and adult patients suitable for orthodontic treatment.
- •Presence of permanent dentition.
- •Good oral hygiene.
排除标准
- •History of chronic systemic disease.
- •Presence of active gingival or periodontal disease.
- •Known allergy or hypersensitivity to vitamin D.
- •Pregnancy or lactation.
- •History of previous orthodontic treatment.
- •Presence of craniofacial anomalies affecting bone physiology.
研究组 & 干预措施
Vitamin D Sufficient Group
Patients with normal serum vitamin D levels. Each patient receives a local Calcitriol delivery on one side of the maxilla, and the other side serves as control (split-mouth).
干预措施: Calcitriol Delivery (Drug)
Vitamin D Deficient Group
Patients with normal serum vitamin D levels. Each patient receives a local Calcitriol delivery on one side of the maxilla, and the other side serves as control (split-mouth).
干预措施: Calcitriol Delivery (Drug)
结局指标
主要结局
Amount of maxillary canine retraction (mm) assessed on CBCT scans
时间窗: T0: immediately before maxillary canine retraction. T1: after completion of canine retraction (approximately 4 months - 6 months)
The amount of maxillary canine movement will be assessed using cone-beam computed tomography (CBCT). Measurements will be expressed in millimeters
次要结局
未报告次要终点
研究者
Ahmed Taha Ahmed Hassan
Postgraduate Researcher (Master's Candidate)
Al-Azhar University