| CTRI Number |
CTRI/2022/06/043279 [Registered on: 15/06/2022] Trial Registered Prospectively |
| Last Modified On: |
30/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
UNDERSTANDING THE SHARED RISK FACTORS OF NON-COMMUNICABLE DISEASES(NCDS) AND PERIODONTAL DISEASE IN INDIAN ADULTS AND TO DEVELOP MEDICAL DENTAL INTEGRATION MODEL BASED ON COMMON RISK FACTOR APPROACH |
|
Scientific Title of Study
|
Assessment of common risk factors of Non-communicable diseases
and Periodontal disease and development of Medical Dental Integration Model
|
| Trial Acronym |
CRF-NCD/PD |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Lakshmi P |
| Designation |
Reader |
| Affiliation |
MCODS, Manipal |
| Address |
Manipal Academy of Higher Education
Udupi KARNATAKA 576104 India |
| Phone |
09895318015 |
| Fax |
|
| Email |
lakshmi.puzhankara@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Lakshmi P |
| Designation |
Reader |
| Affiliation |
MCODS, Manipal |
| Address |
Manipal Academy of Higher Education
Udupi KARNATAKA 576104 India |
| Phone |
09895318015 |
| Fax |
|
| Email |
lakshmi.puzhankara@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Lakshmi P |
| Designation |
Reader |
| Affiliation |
MCODS, Manipal |
| Address |
Manipal Academy of Higher Education
Udupi KARNATAKA 576104 India |
| Phone |
09895318015 |
| Fax |
|
| Email |
lakshmi.puzhankara@gmail.com |
|
|
Source of Monetary or Material Support
|
| KMC, Manipal |
| MCODS, Manipal |
|
|
Primary Sponsor
|
| Name |
Lakshmi P |
| Address |
Room No 3, Department of Periodontology, MCODS, Manipal |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Lakshmi P |
Manipal College of Dental Sciences Manipal |
Room No 3, Department of Periodontology, MCODS, Manipal Udupi KARNATAKA |
9895318015
lakshmi.puzhankara@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I60-I69||Cerebrovascular diseases, (2) ICD-10 Condition: I10-I16||Hypertensive diseases, (3) ICD-10 Condition: E08-E13||Diabetes mellitus, (4) ICD-10 Condition: I70-I79||Diseases of arteries, arterioles and capillaries, (5) ICD-10 Condition: K05||Gingivitis and periodontal diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
The subject will be selected based on the presence or absence of the conditions (NCDs and/or Periodontal Disease) and divided into three groups
1. Patients with either one or more NCDs with Periodontal Disease-Group A
2. Patients with either one or more NCDs with no Periodontal Disease-Group B
3. Patients with Periodontal Disease with no NCDs-Group C
|
|
| ExclusionCriteria |
| Details |
1. Subjects with no NCD or Periodontal disease
2. Subjects not willing to participate in the study
3. Moribund patients
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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 |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="600" Sample Size from India="600"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="600" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
24/06/2022 |
| Date of Study Completion (India) |
03/04/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Protocol has been published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Non-communicable
diseases (NCDs) are chronic diseases that are not directly transmissible from
one person to another and depict the true meaning of the word insidious as it
results in over 71% of all deaths globally and often remain undetected until
the condition has reached a nearly fatal stage especially in low and middle income
countries. (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 5th
leading cause of global deaths.(2)In 2016, Ischemic heart disease and stroke
were recorded as the world’s biggest killers, and these conditions continue to
maintain their lead role in global deaths. COPD, Cancers, Diabetes are not far
behind the Cardiovascular conditions in being the major causes of deaths
worldwide.(2) Tobacco use, physical inactivity, unhealthy diet and the harmful
use of alcohol are modifiable risk factors that can lead to an increase in the
risk of NCDs. Elevated blood pressure, overweight/obesity, hyperglycaemia (high
blood glucose levels) and hyperlipidaemia (high levels of fat in the blood) are
the metabolic risk factors that can bring about metabolic changes that in turn
contribute towards an increase in the risk for NCDS.(3) Stress and social
determinants of health such as a person’s economic and social conditions can
also increase the risk for NCDs.(4) The burden of NCDs on National economies is
tremendous with an estimated loss of 9 billion international dollars in
national income in India in 2005 due to death or inability to work due to heart
disease, stroke and diabetes.(5)
Periodontitis,
as an inflammatory, non-communicable disease with a multifactorial aetiology is
an extremely prevalent condition. More than 10% of the adult population
worldwide are affected by severe periodontitis and the condition may even be
more prevalent than cardiovascular diseases. Periodontal disease is estimated
to be the 11th most prevalent disease globally with an overall prevalence of
7.4% and around 538 million people are affected.(6) According to the Global
Burden of Disease Study, periodontal diseases are responsible for 3.5 million
years lived with disability. (3)Periodontitis also compromises speech, reduces
quality of life, and is an escalating burden to the healthcare economy(6) and
it shares numerous risk factors like smoking, obesity, nutrition, low
socioeconomic status and stress with other Non-Communicable Diseases (NCDs)
like Diabetes, Cancer, Cardiovascular and Cerebrovascular
diseases.(7)(8)(9)(10) Patients with periodontitis are at risk of multiple
tooth loss, edentulism and masticatory dysfunction and this in turn can affect
their food habits and level of nutrient rich food intake. The quality of life
and self-esteem of an individual also will be affected in addition to imposing
huge socio-economic impact and healthcare costs. (6)(11)The global cost of lost
productivity from severe periodontitis alone has been estimated to be 54
billion USD/year. The total economic impact of periodontal diseases has been
estimated at 440 billion USD (direct and indirect costs) in 2010. In the UK,
managing periodontal disease cost the National Health Service over £2.8 billion
in 2017.(12)
Clustering
of risk factors has been observed especially in relation to the NCDs. (13) The
co-occurrence of several characteristics in one individual is termed as
clustering.(13) The concept of clustering of risk factors revolves around
multiple factors. For example, socioeconomic position in childhood has strong
effects on distributions of risk factors in adult life leading to the
hypothesis that socioeconomic position might be associated with clustering of
risk factors for Cardiovascular diseases, Diabetes mellitus and other NCDs.
Clustering occurs when the observed prevalence of a combination of factors
exceeds the expected prevalence for this combination.(14) Behavioural and
demographic characteristics that predisposes towards major chronic diseases
frequently cluster in the same individuals. Drinking and smoking; smoking and
consumption of food high in fats and sugars and low in fibre, polyunsaturated
fatty acids, fruit and nutrient rich foods containing Vit A, C and E; Unhealthy
diet, sedentary lifestyle and deleterious life habits are often seen grouped
together in people. (14)(15)
Interventions
addressing multiple behavioural, environmental and other risk factors have
greater impact than those aimed at isolated behaviors.(16) The concept of
Common Risk Factor Approach (CRFA) is based on the scientific concept that if
disease A is caused by C and disease B is caused by C, then reduction of C
should facilitate the reduction of both A and B, that is, controlling a small
number of risk factors can have tremendous impact on controlling a large number
of chronic conditions. Impetus for Common Risk Factor Approach (CRFA) for
tackling the common risk factors associated with the NCDs has been cresting for
a while in the world of healthcare. (17) Several programs have been initiated
in which CRFA has been implemented to achieve better general health.(18)(19)A few
advocacy initiatives focusing on CRFA in relation to oral health and general
health have attempted to forge the relation between NCDs and oral health
through the commonality of risk factors and thus initiate an active reduction
of the conditions through the CRFA.(20)(21)(22)(23)
Public
health approach for prevention of periodontal disease as a component of an
integrated approach with systemic health, particularly with non-communicable
disease prevention activities, focusing on common risk factors, can pave the
way towards better overall health with a concomitant reduction in health care
costs. Consequently, the model of a common risk factor approach (CRFA) has been
conceptualized for the public health approach to prevent periodontal disease.
The
limited availability of numerical data on the influence of the various risk
factors on the NCDs and on periodontal disease makes it difficult to bring out
a fool-proof plan to create a convincing argument favoring Common Risk Factor
Approach. This research has been designed to overcome the deficiency in
literature in relation to the quantification of the common risk factors between
periodontal disease and NCDs. Policies are based on evidence and evidence is
based on statistics. The quantification of percentage overlap of risk factors
between NCDs and Periodontal disease would result in the development of
advocacy initiatives which would help in reduction of risk factors associated
with periodontal disease and NCDs.The capacity building demonstration model of
Integration of Periodontal health (oral health) in primary health care will be
aimed to facilitate the development of avenues for effective integration of
medical and dental care administration.This research
has been planned to answer the question on what is the attributable risk for
factors that are common between periodontal disease and other major
non-communicable diseases (Diabetes Mellitus type 2, Cardiovascular disease) in
adults?
This study is based on the rationale that periodontal disease shares a
wide range of risk factors and risk indicators such as tobacco use and alcohol,
dietary factors, stress, plaque microbiota, oral hygiene, social determinants
of health(SDH) with other systemic diseases conditions particularly the other
major NCDs such as cardiovascular disease, chronic respiratory disease, cancer,
and diabetes. Quantification of these risk factors would enable the
implementation of Common Risk Factor Approach for the integration of
periodontal disease prevention into public health approaches for NCD prevention
and control activities |