Assessment the Efficacy of Curcumin Local Delivery Gel in Treatment of Periodontitis in Smokers. Randomized Controlled Clinical Trial
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- probing pocket depth
研究概览
简要总结
Smokers usually respond less favourably to non-surgical periodontal treatment compared to non-smokers. Numerous studies reported that smoker patients exhibited less reduction in probing depth and less gains in clinical attachment level values following scaling and root planing (Kanmaz et al., 2021, Alwithanani, 2023)
Several studies have proposed the use of adjunctive treatment approaches such as local/systemic antimicrobials and anti-inflammatory agents to improve the effects of basic periodontal therapy in smokers. However, no studies have been published evaluated the conventional management of topically delivered curcumin gel in conjunction with scaling and root planing demonstrating its ability to improve periodontal outcomes in smokers.
Meanwhile, some clinical trials indicate that local and systemic administration of curcumin can enhance the results of SRP in periodontal treatment. Local delivery allows higher concentrations of the active compounds in the diseased site and avoids possible adverse effects of systemic administration.
详细描述
Tobacco use increases the risk and progression of periodontitis by multiple factors including decreased gingival perfusion, which restricts nutrients and oxygen delivery as well as the removal of waste products. In addition, it affects the circulating levels of immune-inflammatory cells in gingival crevicular fluid, and affects the dysbiosis microbiota reducing the ability of the periodontium to repair.
Curcumin is an extract from the turmeric plant Curcuma longa L. It has been shown potent anti-microbial, anti-carcinogenic, antiviral, antioxidant, and anti-inflammatory properties.
In periodontitis, curcumin plays a pivotal role in anti-inflammatory properties, by inhibiting pro-inflammatory cytokines, reducing the prostaglandin biosynthesis, inhibiting the mRNA and protein expression of cyclo-oxygenase-2, through down-regulation of NF-kB activation.
Meanwhile, some clinical trials indicate that local and systemic administration of curcumin can enhance the results of SRP in periodontal treatment; local delivery allows higher concentrations of the active compounds in the diseased site and avoids possible adverse effects of systemic administration (Pérez-Pacheco et al., 2021, Borgohain et al., 2023, Chatzopoulos et al., 2023).
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
- Double (Participant, Outcomes Assessor)
盲法说明
Double blinded
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients diagnosed with generalized periodontitis with stage II
- •Nonsurgical or surgical periodontal therapy in the last 3 months were considered as eligible for the study.
- •Current smoker or smoker over the past 5 years.
排除标准
- •Presence of overhanging restorations,
- •antibiotics or any form of periodontal therapy in the previous 6 months.
- •History of systemic disease, cardiovascular diseases, diabetes mellitus, hypertension, bleeding disorders, hyperparathyroidism, and compromised medical conditions, pregnancy and lactation.
- •Teeth with both endo-perio lesions.
- •Patient on antibiotics within 3 months prior to the study.
研究组 & 干预措施
SRP with local delivery of Curcumin gel
Scaling and root planing in combination with local delivery of Curcumin gel
干预措施: local delivery of Curcumin gel (Drug)
SRP alone
Scaling and root plaing alone
干预措施: local delivery of Curcumin gel (Drug)
结局指标
主要结局
probing pocket depth
时间窗: 45 days
The depth of the pocket will be measured from the gingival margin to the base of the pocket.
clinical attachment level
时间窗: 45 days
The clinical attachment level will be measured from the CEJ to the base of pocket.
次要结局
- gingival index(45 days)
- Paque index(45 days)
研究者
Parryhan Mohamed Abdelsamie
Lecturer of periodontology
Cairo University