Clinical evaluation of nigella sativa gel application as an adjunctive to periodontal flap surgery in stage three periodontitis patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Measurement of Clinical Attachment level
研究概览
简要总结
This study is a randomized, parallel group clinical trial comparing the- clinical evaluation of nigella sativa gel application as an adjunctive to periodontal flap surgery in stage iii periodontitis patients . In 2023, The study tested the antibacterial effect of Nigella sativa (black seed) extract against Porphyromonas gingivalis, a major bacteria in gum disease. Six periodontitis patients (ages 30–50) were included. Laboratory tests showed that at 12.5 mg/ml, the extract had no effect, but at 25 mg/ml, it produced a 6.2 mm zone of inhibition, indicating antibacterial activity. The results suggest that Nigella sativa may be useful as a natural adjunct to scaling in periodontitis treatment.
Group 1: Periodontal flap surgery + application of nigella sativa
Group 2: Periodontal flap surgery alone
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 30.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Age group 30-55 years of both the gender Subjects who are apparently healthy.
- •Subjects with maximum probing depth greater than 5mm, Clinical Attachment loss of greater 4mm in any quadrant Subjects who are willing to give informed consent.
排除标准
- •Subjects using any form of tobacco.
- •Patients with crowding of teeth.
- •Patients who had underwent any kind of periodontal surgery History of previous antibiotic therapy within the past 3 months.
- •Subjects who have history of drug allergy.
- •Pregnant woman and Lactating mothers.
结局指标
主要结局
Measurement of Clinical Attachment level
时间窗: At baseline and 3 months
Probing Pocket Depth
时间窗: At baseline and 3 months
次要结局
- Gingival index(wound healing Index)
研究者
Upputuri Venga Urekha
SIBAR INSTITUTE OF DENTAL SCIENCES