跳至主要内容
临床试验/CTRI/2025/02/080183
CTRI/2025/02/080183尚未招募4 期

A COMPARISON OF EFFICACY OF SUB-GINGIVAL DELIVERY OF NANOPARTICLE PROPOLIS GEL AND NANOCATECHIN GEL AS ADJUNCTS TO NON SURGICAL PERIODONTAL THERAPY ON INTERLEUKIN 1-BETA LEVELS IN CHRONIC PERIODONTITIS PATIENTS-A CLINICAL AND IMMUNOLOGICAL ASSAY

Panineeya Mahavidyalaya Institute of Dental Sciences and Research Centre1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2025年2月10日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
42
试验地点
1
主要终点
Clinical improvement with both the gels.

研究概览

简要总结

Periodontal pockets present an ideal site for treatment using localized drug delivery systems. Within the field of periodontics, there are established approaches for delivering drugs directly to subgingival sites or periodontal pockets. There are a range of local drug delivery systems including  fibers, gels, strips, films, irrigating systems, microparticles and nanoparticles. 

LOCAL DRUG DELIVERYLocal drug delivery system is the application of anti- microbial or anti-infective agent that would target pathogenic microorganisms by delivering it at the base of the pocket yielding a stable and good clinical outcome along with mechanical debridement.

PROPOLISPropolis is a natural, non-toxic, resinous, yellow–brown to dark    brown substance collected through honey bees from trees, and other plant sources.  Due to its beneficial properties like antimicrobial, anticancer, antifungal, antiviral, and anti-inflammatory effects, Propolis has been used extensively for  for the management of periodontal pocket in patients with periodontitis in various forms such as paste, tablet, ointment, oil, mouthwash, etc.

CATECHIN Catechin  is the active substance of the green tea plant known for its very useful and prominent biological functions such as antimicrobial, anti-cancer, antioxidant, and anti-inflammatory activity. Its strong antimicrobial effects  reduces gingival inflammation.

INTERLEUKIN beta 1A pro-inflammatory-cytokine, that participates in immune regulation and bone resorption in periodontitis. It is mainly expressed in gingival fibroblasts, periodontal ligament cells, and osteoblasts. IL-1beta increases the expression of collagenolytic enzymes, matrix metalloproteinases MMPs,  which contribute to extracellular matrix degradation and in turn lead to bone resorption and tissue destruction, an important indicator of the severity and progression of periodontitis.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
25.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • Patients aged between 25 to 55 years.
  • Probing Pocket Depth PPD greater than 5mm.
  • Patients who have not received periodontal therapy, within preceding 6 months of the study.

排除标准

  • Patients who were on antibiotics/anti inflammatory drugs in the last 3 months.
  • Pregnant and lactating females.
  • Medically compromised patients.
  • Smokers, tobacco chewers and alcoholics.
  • Patients who are allergic to drugs.

结局指标

主要结局

Clinical improvement with both the gels.

时间窗: Baseline 6 weeks 3 months

Which gel is superior to the other?

时间窗: Baseline 6 weeks 3 months

次要结局

  • Clinical improvement with both the gels.(Which gel is superior to the other?)

研究者

发起方
Panineeya Mahavidyalaya Institute of Dental Sciences and Research Centre
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

GHIMA BINDU

Panineeya Mahavidyalaya institute of dental sciences and research centre

研究点 (1)

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