Efficacy of Locally Applied Nano-Curcumin and Nano-Hyaluronic Acid as an Adjunct to Scaling and Root Planing in the Treatment of Periodontitis Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Probing pocket depth reduction
研究概览
简要总结
to evaluate Efficacy of Locally Applied Nano-Curcumin and Nano-Hyaluronic Acid as an Adjunct to Scaling and Root Planing in the Treatment of Periodontitis patients
Materials and methods: forty patients (n=40) were selected from the Department of Oral Medicine and Periodontology, Faculty of Dentistry, Mansoura University, The participants forty patients are classified into four groups:
- Group1 : (-ve control group): SRP alone
- Group2: (+ve control group): SRP+ chitosan Nano-particles
- Group3: SRP + Curcumin-coated chitosan Nano-particles
- Group4: SRP+ hyaluronic acid -coated chitosan Nano-particle
All Patients will undergo Phase I therapy, which includes scaling and root planing using ultrasonic tips and gracey curettes. Additionally, mechanical oral hygiene instructions will be provided, and participants will be advised to refrain from using any mouthwash throughout the duration of the study.
Furthermore, patients within groups 2 to 4 will be subjected to an extra measure involving the application of the respective gel associated with their designated group. The gel will be administered on a weekly basis for duration of five weeks.
Clinical indices (plaque index (PI), gingival index (GI), clinical attachment level (CAL), and probing depth (PD)). Laboratory assessment will be done at baseline and final assessment( after 3 months) . tess will be for antioxdiant levels and TNF alpha
- Total anti-oxidant capacity(T-AOC) using Assay kit50T
- TNF alpha using ELISA Kit (96T)
详细描述
Inclusion criteria:
Patients who are systemically healthy Patient exhibiting periodontal pocket depths (PD) ≤5mm presence of clinical attachment loss (CAL) between 1-4mm cooperative individuals capable of adhering to mechanical oral hygiene instructions Patients who agreed on both written and verbal consent to participate in the study.
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o Exclusion criteria: patients with recent history of periodontal treatment (within the last 3 months) patients with recent use of antibiotic (within the past 3 months, pregnant or lactating women, individuals who are malnourished and taking vitamin supplements, Patients who regularly use mouthwashes.
Method of gel application: a blunt 2ml syringe will be used to administer the gel sub-gingivally until the pocket is filled
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are systemically healthy
- •Patient exhibiting periodontal pocket depths (PD) ≤5mm
- •presence of clinical attachment loss (CAL) between 1-4mm
- •cooperative individuals capable of adhering to mechanical oral hygiene instructions
- •Patients who agreed on both written and verbal consent to participate in the study.
排除标准
- •patients with recent history of periodontal treatment (within the last 3 months)
- •patients with recent use of antibiotic (within the past 3 months)
- •pregnant or lactating women,
- •individuals who are malnourished and taking vitamin supplements,
- •Patients who regularly use mouthwashes.
研究组 & 干预措施
group 1 (-ve control group) SRP alone
are treated with scaling and root planning alone
干预措施: scaling and root planning (Procedure)
group 2 ( +ve control group) SRP + chitosan nano-particles LDD
patients are treated with SRP in addition to chitosan nano-particles as an adjunct local drug delivery.
干预措施: chitosan nano-particles (Drug)
group 3 ( experimental group 1) SRP + curcumin loaded on chitosan nano-particles
patients are treated with SRP in addition to curcumin loaded on chitosan nano-particles as an adjunct local drug delivery.
干预措施: curcurmin loaded on chitosan nano-particles (Drug)
group 4 ( experimental group 2) SRP + hyaluronic acid loaded on chitosan nano-particles
patients are treated with SRP in addition to hyaluronic-acid loaded on chitosan nano-particles as an adjunct local drug delivery.
干预措施: hyaluronic acid loaded on chitosan nano-particles (Drug)
结局指标
主要结局
Probing pocket depth reduction
时间窗: 12 weeks
pocket depth is calculated using a UNC 15 perio probe to calculate the distance between the base of the pocket to the free gingival margin
次要结局
- plaque index(12 weeks)
- clinical attachment gain(12 weeks)
- Gingival Bleeding Index(12 weeks)
- o Total anti-oxidant capacity(T-AOC)(12 weeks)
- tumor necrosis factor alpha (TNF alpha)(12 weeks)