the Role of Vitamin E in Reducing Incidence of Dry Socket in Female Patients. A Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Decrease of incidence of dry socket and pain
研究概览
简要总结
90 female patients seeking extraction of a single tooth in the lower posterior region were divided randomly into 45 patients received vitamin E inside the socket after extraction (study group) and 45 patients didn't receive vitamin E after extraction (control group).
详细描述
I. Patient Selection and Grouping:
This study was conducted on a total number of 90 female patients seeking extraction of a single tooth in the lower posterior region, selected from those attending the outpatient clinic of the oral and maxillofacial surgery department in the faculty of dentistry, Ain Shams University and Misr University for Science & Technology, Egypt as divided randomly into 45 patients received vitamin E inside the socket after extraction (study group) and 45 patients didn't receive vitamin E after extraction (control group).
II. Sample Size Calculation:
In the prior assessment of the article by Haraji et al. (Effects of Intra-alveolar Placement of 0.2% Chlorhexidine Bioadhesive Gel on Dry Socket Incidence and Postsurgical Pain: A Double-Blind Split-Mouth Randomized Controlled Clinical Trial) and setting alpha at 0.05 and Beta at 0.8 the data showed that the minimum number of patients to be included in each group was 18.
III. Blinding\Masking:
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double blinded
入排标准
- 年龄范围
- 30 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female patients 30-50 years of age.
- •Patients with single tooth in the lower posterior region need simple extraction.
- •Compliance with all requirements in the study and signing the informed consent.
排除标准
- •Patients with any medical condition that may influence the outcome (uncontrolled diabetes, Hyperparathyroidism, Hyperthyroidism, Cushing's disease, Paget's disease, Glucocorticoids).
- •Vulnerable groups (children, pregnant women, elderly people, malnourished people, prisoners, migrants, and refugees).
- •Patients with systemic disease affecting bone healing (osteoporosis, Rickets, and osteomalacia).
- •Chronic Patients on medications known to affect the periodontal status (calcium antagonists, anticonvulsive, immunosuppressive, anti-inflammatory medications).
- •Patients with a history of bisphosphonate use.
- •Pathologic lesions in the site of extraction.
- •Lactating mothers.
- •Smoking patients.
- •Patients currently on radiotherapy and or chemotherapy treatment.
研究组 & 干预措施
study group
patients received vitamin E inside the socket after extraction (study group)
干预措施: Vitamin E application (Drug)
结局指标
主要结局
Decrease of incidence of dry socket and pain
时间窗: one week
Evaluation of patient satisfaction and pain was done and recorded according to VAS which is a scale from 1-10. patient mention degree of pain on this scale
次要结局
未报告次要终点