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临床试验/CTRI/2022/06/043279
CTRI/2022/06/043279已完成不适用

Assessment of common risk factors of Non-communicable diseases and Periodontal disease and development of Medical Dental Integration Model

Lakshmi P1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2022年6月24日最近更新:
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试验速览

阶段
不适用
状态
已完成
发起方
入组人数
600
试验地点
1
主要终点
Proportion of risk factors more likely to be shared between periodontal disease and other major non-communicable diseases (NCDs-Diabetes Mellitus type 2, cardiovascular disease) in adults

研究概览

简要总结

Non-communicablediseases (NCDs) are chronic diseases that are not directly transmissible fromone person to another and depict the true meaning of the word insidious as itresults in over 71% of all deaths globally and often remain undetected untilthe condition has reached a nearly fatal stage especially in low and middle incomecountries. (1) Cardiovascular diseases (like heart attacks and stroke),cancers, chronic respiratory diseases and diabetes are the major NCDs.(1)Dementias are also on the rise with Deaths due to Dementias becoming the 5thleading cause of global deaths.(2)In 2016, Ischemic heart disease and strokewere recorded as the world’s biggest killers, and these conditions continue tomaintain their lead role in global deaths. COPD, Cancers, Diabetes are not farbehind the Cardiovascular conditions in being the major causes of deathsworldwide.(2) Tobacco use, physical inactivity, unhealthy diet and the harmfuluse of alcohol are modifiable risk factors that can lead to an increase in therisk of NCDs. Elevated blood pressure, overweight/obesity, hyperglycaemia (highblood glucose levels) and hyperlipidaemia (high levels of fat in the blood) arethe metabolic risk factors that can bring about metabolic changes that in turncontribute towards an increase in the risk for NCDS.(3) Stress and socialdeterminants of health such as a person’s economic and social conditions canalso increase the risk for NCDs.(4) The burden of NCDs on National economies istremendous with an estimated loss of 9 billion international dollars innational income in India in 2005 due to death or inability to work due to heartdisease, stroke and diabetes.(5)

Periodontitis,as an inflammatory, non-communicable disease with a multifactorial aetiology isan extremely prevalent condition. More than 10% of the adult populationworldwide are affected by severe periodontitis and the condition may even bemore prevalent than cardiovascular diseases. Periodontal disease is estimatedto be the 11th most prevalent disease globally with an overall prevalence of7.4% and around 538 million people are affected.(6) According to the GlobalBurden of Disease Study, periodontal diseases are responsible for 3.5 millionyears lived with disability. (3)Periodontitis also compromises speech, reducesquality of life, and is an escalating burden to the healthcare economy(6) andit shares numerous risk factors like smoking, obesity, nutrition, lowsocioeconomic status and stress with other Non-Communicable Diseases (NCDs)like Diabetes, Cancer, Cardiovascular and Cerebrovasculardiseases.(7)(8)(9)(10) Patients with periodontitis are at risk of multipletooth loss, edentulism and masticatory dysfunction and this in turn can affecttheir food habits and level of nutrient rich food intake. The quality of lifeand self-esteem of an individual also will be affected in addition to imposinghuge socio-economic impact and healthcare costs. (6)(11)The global cost of lostproductivity from severe periodontitis alone has been estimated to be 54billion USD/year. The total economic impact of periodontal diseases has beenestimated at 440 billion USD (direct and indirect costs) in 2010. In the UK,managing periodontal disease cost the National Health Service over £2.8 billionin 2017.(12)

Clusteringof risk factors has been observed especially in relation to the NCDs. (13) Theco-occurrence of several characteristics in one individual is termed asclustering.(13) The concept of clustering of risk factors revolves aroundmultiple factors. For example, socioeconomic position in childhood has strongeffects on distributions of risk factors in adult life leading to thehypothesis that socioeconomic position might be associated with clustering ofrisk factors for Cardiovascular diseases, Diabetes mellitus and other NCDs.Clustering occurs when the observed prevalence of a combination of factorsexceeds the expected prevalence for this combination.(14) Behavioural anddemographic characteristics that predisposes towards major chronic diseasesfrequently cluster in the same individuals. Drinking and smoking; smoking andconsumption of food high in fats and sugars and low in fibre, polyunsaturatedfatty acids, fruit and nutrient rich foods containing Vit A, C and E; Unhealthydiet, sedentary lifestyle and deleterious life habits are often seen groupedtogether in people. (14)(15)

Interventionsaddressing multiple behavioural, environmental and other risk factors havegreater impact than those aimed at isolated behaviors.(16) The concept ofCommon Risk Factor Approach (CRFA) is based on the scientific concept that ifdisease A is caused by C and disease B is caused by C, then reduction of Cshould facilitate the reduction of both A and B, that is, controlling a smallnumber of risk factors can have tremendous impact on controlling a large numberof chronic conditions. Impetus for Common Risk Factor Approach (CRFA) fortackling the common risk factors associated with the NCDs has been cresting fora while in the world of healthcare. (17) Several programs have been initiatedin which CRFA has been implemented to achieve better general health.(18)(19)A fewadvocacy initiatives focusing on CRFA in relation to oral health and generalhealth have attempted to forge the relation between NCDs and oral healththrough the commonality of risk factors and thus initiate an active reductionof the conditions through the CRFA.(20)(21)(22)(23)

Publichealth approach for prevention of periodontal disease as a component of anintegrated approach with systemic health, particularly with non-communicabledisease prevention activities, focusing on common risk factors, can pave theway towards better overall health with a concomitant reduction in health carecosts. Consequently, the model of a common risk factor approach (CRFA) has beenconceptualized for the public health approach to prevent periodontal disease.

Thelimited availability of numerical data on the influence of the various riskfactors on the NCDs and on periodontal disease makes it difficult to bring outa fool-proof plan to create a convincing argument favoring Common Risk FactorApproach. This research has been designed to overcome the deficiency inliterature in relation to the quantification of the common risk factors betweenperiodontal disease and NCDs. Policies are based on evidence and evidence isbased on statistics. The quantification of percentage overlap of risk factorsbetween NCDs and Periodontal disease would result in the development ofadvocacy initiatives which would help in reduction of risk factors associatedwith periodontal disease and NCDs.The capacity building demonstration model ofIntegration of Periodontal health (oral health) in primary health care will beaimed to facilitate the development of avenues for effective integration ofmedical and dental care administration.This researchhas been planned to answer the question on what is the attributable risk forfactors that are common between periodontal disease and other majornon-communicable diseases (Diabetes Mellitus type 2, Cardiovascular disease) inadults?

This study is based on the rationale that periodontal disease shares awide range of risk factors and risk indicators such as tobacco use and alcohol,dietary factors, stress, plaque microbiota, oral hygiene, social determinantsof health(SDH) with other systemic diseases conditions particularly the othermajor NCDs such as cardiovascular disease, chronic respiratory disease, cancer,and diabetes. Quantification of these risk factors would enable theimplementation of Common Risk Factor Approach for the integration ofperiodontal disease prevention into public health approaches for NCD preventionand control activities

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • •The subject will be selected based on the presence or absence of the conditions (NCDs and/or Periodontal Disease) and divided into three groups
  • •Patients with either one or more NCDs with Periodontal Disease-Group A
  • •Patients with either one or more NCDs with no Periodontal Disease-Group B
  • •Patients with Periodontal Disease with no NCDs-Group C.

排除标准

  • •Subjects with no NCD or Periodontal disease
  • •Subjects not willing to participate in the study
  • •Moribund patients.

结局指标

主要结局

Proportion of risk factors more likely to be shared between periodontal disease and other major non-communicable diseases (NCDs-Diabetes Mellitus type 2, cardiovascular disease) in adults

时间窗: Baseline

次要结局

未报告次要终点

研究者

发起方
Lakshmi P
申办方类型
Other [self]

研究点 (1)

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