Efficacy of Quercetin Nanoemulgel as Adjunct Local Delivery Drug in Non-surgical Treatment of Periodontitis
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- reactive oxygen species (ROS)
研究概览
简要总结
Periodontitis is an immune-inflammatory disease affecting the supporting structures of the teeth. It is a disease of multifactorial etiology, with microbial, genetic, environmental and host factors involved, with the release of oxygen-free radicals by the inflammatory cells. Quercetin, have shown potential antimicrobial activity, lowering of inflammatory markers, cholesterol reduction and inhibiting bone loss. However, this data has largely been obtained from in vitro and animal studies, but data from human studies are limited.
详细描述
Quercetin has been found to decrease the extracellular matrix degradation, promote wound healing when tested in gingival fibroblasts, and showed excellent antibacterial properties. It also possesses antioxidant effect which can be explored to restrict the inflammation in periodontitis. Despite the beneficial effects of Quercetin, its poor aqueous solubility and poor bioavailability result in limited absorption, so scientists have worked on improving the bioavailability of Quercetin using various approaches, such as nanosuspension , self-nano emulsifying systems , microemulsion , solid lipid nanoparticles and cyclodextrin complexes. The combination of oils and emulsifiers enhances the absorption of Quercetin. Hence, nanoemulsion could be a suitable drug delivery vehicle for the loading of Quercetin. Nanoemulsions are more beneficial than microemulsions, as they have high kinetic stability and a smaller droplet size. Therefore, the present study will investigate the efficacy of nanoemulgel of quercetin as adjunct to conventional therapy in treatment of periodontitis.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria:
- •Patients with periodontitis stage ( Ⅰ & Ⅱ ). Stage I have CAL 1 to 2mm with no tooth loss and probing depth ≤4 mm. Stage II have CAL 3 to 4mm with no tooth loss and probing depth ≤5 mm..
- •Patients who have teeth with both mesial and distal neighboring teeth .
- •Patient with more than 20 natural teeth .
- •Patient free from any systemic disease that may effect the periodontal status according to the criteria of Cornell Medical Index and its modification.
排除标准
- •Long-term therapy with medications within a month prior to enrollment that could affect periodontal status or healing.
- •Pregnant woman and lactating mothers .
- •Patients with a history of traumatic occlusion.
- •Teeth with both endo-perio lesion .
- •Patients with previous periodontal treatment including scaling and root planing and periodontal surgery in the last 3 and 6 months, respectively .
研究组 & 干预措施
Group(I):scaling and root planing only
10 sites will receive non-surgical periodontal therapy (scaling and root planing) .
干预措施: scaling and root planing (Device)
Group(Ⅱ):scaling and root planing with application of quercetin nanoemulgel
10 sites will receive non-surgical periodontal therapy followed by the application of quercetin nanoemulgel local delivery 2 times one at the day of non-surgical periodontal therapy and after 2 weeks.
干预措施: Quercetin (Drug)
Group(Ⅱ):scaling and root planing with application of quercetin nanoemulgel
10 sites will receive non-surgical periodontal therapy followed by the application of quercetin nanoemulgel local delivery 2 times one at the day of non-surgical periodontal therapy and after 2 weeks.
干预措施: scaling and root planing (Device)
结局指标
主要结局
reactive oxygen species (ROS)
时间窗: at base line, 1 month and 3 months after treatment
The samples were assayed for antioxidant effect of quercetin using commercially available reactive oxygen species( ROS) kit . Highly sensitive ROS kit was used according to the manufacturer's instruction
Evaluation of the changes in the clinical attachment loss
时间窗: at base line, 1 month and 3 months after treatment
Attachment level was measured using UNC15(University of North Carolina) periodontal probe. Clinical attachment loss was measured as the distance from the cemento-enamel junction to the base of the pocket.
Probing depth
时间窗: at base line, 1 month and 3 months after treatment
The measurement were recorded by UNC15(University of North Carolina) periodontal probe . Pocket depth was measured as the distances from the free gingival margin to the base of the periodontal pocket.
interferon IFN-γ analysis
时间窗: at base line, 1 month and 3 months after treatment
The samples were assayed for (IFN-γ) levels using commercially available enzyme-linked immune-sorbent assay (ELISA) . Highly sensitive ELISA kit was used to detect the (IFN-γ) level in pg/ml in the sample of GCF according to the manufacturer's instructions.
次要结局
- Gingival index (GI)(at base line, 1 month and 3 months after treatment)
- Plaque index (PI)(at base line, 1 month and 3 months after treatment)
研究者
Alzahraa Alghriany
Lecturer, Oral medicine, Periodontology and Oral diagnosis, Faculty of dentistry
Assiut University