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临床试验/CTRI/2024/07/071735
CTRI/2024/07/071735尚未招募不适用

An Exploratory Comparative Study of the Efficacy of Locally Delivered 3 Percent Psidium Guajava Gel and Probiotic Gel as an Adjunct to Non Surgical Periodontal Therapy in Chronic Periodontitis- A Clinical and Microbiological Assay

Panieenya Mahavidyala Institute of dental sciences and research centre1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2024年8月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
45
试验地点
1
主要终点
To evaluate and compare the clinical outcome of locally delivered 3%Psidium guajava gel and probiotic gel.

研究概览

简要总结

·       Chronic periodontitis is an infectious disease resulting in inflammation within the supporting tissues of the teeth, leading to the progressive attachment loss and bone loss

·       Elevated levels of certain microbiological species are associated with the disease. It is essential to minimize the microbial load to combat the infection.

·       Non surgical therapy such as scaling and root planing along with certain chemical antibacterial strategies such as systemic antibiotics and oral rinses and irrigating agents are generally used.

·       But, none of these therapies have provided significant clinical benefit in reducing the clinical signs of chronic periodontal disease and also side effects are not uncommon with systemic antibiotics

·       To overcome this, a new strategy has emerged to deposit antimicrobials directly into pocket and maintain effective concentration of the drug  for an extended period. This is known as LOCAL DRUG DELIVERY

 Â·       In an attempt to overcome the limitations of mechanical debridement and ill effects of chemotherapeutic agents, research still continues to find new and better alternatives to conventional treatment protocols.One of the alternatives are the medicinal herbs which has been extensively used in ayurveda but lacks sufficient research in modern medicine.

 Â·       Psidium guajava , commonly known as guava, has been used in folk medicine as a therapeutic agent. The leaves of the plant P. guajava are reported to possess antimicrobial, anti-inflammatory and antioxidant properties. It has shown inhibitory effects against staphylococcus aureus,streptococcus mutans,pseudomonas aeruginosa,salmonella enteritidis,bacillus cereus,proteus spp.,shigella spp.and Escherichia coli which causes intestinal infections.

  ·       Probiotics are being used to help in the recolonization of beneficial bacteria as well as to modulate the immune response. These agents have been administered in the form of tablets, gums, lozenges, and mouthrinses to name a few..The most commonly used species of probiotics belong to the Lactobacillus, Bifidobacterium, Escherichia, Enterococcus, and Bacillus genera. These probiotic benefits oral health by defending the growth of harmful bacteria and by modulating mucosal immunity in the oral cavity.

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 guava and probiotics.

结局指标

主要结局

To evaluate and compare the clinical outcome of locally delivered 3%Psidium guajava gel and probiotic gel.

时间窗: 3 months

To evaluate efficacy of locally delivered 3%Psidium guajava gel and probiotic gel on Porphyromonas gingivalis, Treponema denticola, Tanerella forsythia, A. actinomycetemcomitans in chronic periodontitis patients.

时间窗: 3 months

次要结局

  • Variation in clinical parameters after periodontal therapy(Base line & 3 months)

研究者

发起方
Panieenya Mahavidyala 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

Dr Hima Bindu

Panineeya Mahavidyala institute of dental sciences and research centre

研究点 (1)

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