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临床试验/CTRI/2025/03/081853
CTRI/2025/03/081853尚未招募1/2 期

An association between periodontal disease and metabolic syndrome a case control study

Dr Nisha Verlianey1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2025年4月17日最近更新:

试验速览

阶段
1/2 期
状态
尚未招募
发起方
入组人数
500
试验地点
1
主要终点
patient with metabolic syndrome have altered inflammatory and infectious biomarkers which leads to an increase in the incidence of periodontal infection adding to the systemic disease of the body

研究概览

简要总结

Periodontal Infection is a chronic inflammatory disease associated with dysbiotic plaque biofilms and characterized by progressive destruction of the tooth supporting structures. It has a multifactorial etiology with microbial ,environmental and host associated etiologic factors and leads to several elevated inflammatory mediators like C-Reactive Protein and interleukin -6 into the systemic circulation.

Metabolic Syndrome is a cluster of conditions that occur concomitantly and together they increase the risk of cardiovascular diseases and double the risk of type 2 diabetes.The National Cholesterol Education Program Adult Treatment Panel III defines it as an individual with at least three of the following risk factors ;(a) elevated glucose levels ,(b)low plasma levels of high density lipoprotein cholesterol, (c) increased values for plasma triglycerides,(d)elevated blood pressure, (e)increased abdominal circumference.

There has been a common factor of systemic inflammation and insulin resistance in both these diseases and hence they can potentially influence one another.Several studies have suggested that periodontitis can affect systemic conditions.

And successful periodontal treatment can decrease circulating levels of inflammatory mediators.

Aim :

The aim of this study is to evaluate the association between periodontal infection and metabolic syndrome**.**

Objectives

1 To establish the clinical significance of the association between patients having periodontal infection with the dysmetabolic systemic status.

2 To investigate the association of severity of inflammatory and metabolic markers with periodontal disease.

The data will be collected from the 500 patients visiting the OPD of the Department of Periodontology, Government Dental College and Hospital, Jamnagar, Gujarat. After informing the patient about the study and completing the formalities in the consent form, the patients will be enrolled and data collection in the proforma will be done.

The patient data sheet of the subjects will be filled with demographic data, chief complain, habit details and a comprehensive periodontal examination by a single examiner including Probing pocket depth (PPD), Clinical Attachment Levels(CAL) and Oral hygiene

Index-Simplified (OHI-S).

The current metabolic status will be evaluated by Complete Blood Count, Lipid Profile, Hba1c, for average blood sugar status and C-Reactive protein to assess the inflammatory status. The non-invasive data to be recorded will be the abdominal girth, height and weight to calculate the BMI and the waist to hip ratio.

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
20.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • a) Patients between age 20- 65 years b) Patients with at least 20 teeth present in the oral cavity.

排除标准

  • a) Patients with history of periodontal treatment in past 6 months.
  • b) Pregnant and Lactating females.
  • c) Patients with less than 20 teeth present in the oral cavity.
  • CASES will be defined as subjects with metabolic disorder having periodontal infection whereas CONTROLS will be subjects with no systemic condition.

结局指标

主要结局

patient with metabolic syndrome have altered inflammatory and infectious biomarkers which leads to an increase in the incidence of periodontal infection adding to the systemic disease of the body

时间窗: at baseline the assessment of the clinical significance between patients having periodontal infection and the dysmetabolic systemic status of an individual was compared with systemically healthy patient

次要结局

  • Periodontal infection and metaolic syndrome association can be highlighted to the medical professionals and general population.Periodontal therapy can reduce the inflammatory burden on the body and aid in management of systemic diseases.(3 years)

研究者

发起方
Dr Nisha Verlianey
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Nisha Verlianey

government dental college and hospital Jamnagar

研究点 (1)

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