Nigella Sativa Oil Extract and Xenograft Bone Graft in Treatment of Infra-bony Defects: a Combined Clinical and Histological Study
试验速览
- 阶段
- 2 期
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- clinical attachment level
研究概览
简要总结
The aim of this study will be to evaluate, clinically, and radiographically the effect of Nigella Sativa oil extract Mixed with xenograft versus xenograft alone in the treatment of intra-bony defects in patients with aggressive periodontitis.
详细描述
in 10 patients, twenty sites in subjects with, localized aggressive periodontitis, with CAL ≥ 5 will be included in the present study. Sites will be allocated randomly to be surgically treated with, Nigella Sativa oil extract Mixed with xenograft or xenograft alone. At baseline, 3, 6 after surgery, the following clinical parameters (PD, CAL, BOP) and CBCT at baseline and 6 months x-ray will be recorded.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •systemically healthy patients were selected
- •patients who had not received any medications for the previous six months that may interfere with periodontal tissue health or healing.
- •Patients should demonstrate their ability to maintain good oral hygiene
排除标准
- •• Smokers and pregnant patients.
- •Medically compromised patients and systemic conditions precluding periodontal surgery.
- •Subjects who do not comply with oral hygiene measures as evidenced in recall visits.
- •Restoration or caries in the site to be treated or non-vital tooth
- •Restoration or caries in the site to be treated or non-vital tooth
结局指标
主要结局
clinical attachment level
时间窗: 6 months
clinical attachment level will be recorded at baseline, 3, and 6 months at the site to be treated
probing pocket depth
时间窗: 6 months
probing pocket depth probing pocket depth will be recorded at baseline, 3, and 6 months at the site to be treated
bleeding on probing
时间窗: 6 months
bleeding on probing will be recorded at baseline, 3, and 6 months at the site to be treated
cone beam x ray measuring bone fill
时间窗: 6 months
bone fill will be recorded at baseline, and 6 months at the site to be treated
次要结局
未报告次要终点
研究者
Doaa Ahmed Yousef
lecturer
Tanta University