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CTRI Number  CTRI/2020/03/023772 [Registered on: 05/03/2020] Trial Registered Prospectively
Last Modified On: 20/05/2020
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   To understand the barriers and factors that may influence the oral health status of elderly population who are living in slums of Udupi taluk Karnataka. 
Scientific Title of Study   To assess the Oral Health status of Elderly people living in the slums of Udupi Taluk. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mohammad Abdullah 
Designation  PG Student 
Affiliation  Manipal University 
Address  Department of Health Policy, prasanna School Of Public Health, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka, 576104, India

Udupi
KARNATAKA
576104
India 
Phone  7587522515  
Fax    
Email  abdullak13@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sanjay Pattanshetty 
Designation  Associate Professor 
Affiliation  Manipal University 
Address  Department of Health Policy, prasanna School Of Public Health, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka, 576104, India

Udupi
KARNATAKA
576104
India 
Phone  09964381100  
Fax    
Email  sanjay.pattanshetty@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Mohammad Abdullah 
Designation  PG Student 
Affiliation  Manipal University 
Address  Department of Health Policy, prasanna School Of Public Health, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka, 576104, India

Udupi
KARNATAKA
576104
India 
Phone  7587522515  
Fax    
Email  abdullak13@gmail.com  
 
Source of Monetary or Material Support  
Mohammad Abdullah 
 
Primary Sponsor  
Name  Mohammad Abdullah 
Address  Department of Health Policy, Prasanna School Of public Health, Manipal Academy of Higher Education, Manipal, India 
Type of Sponsor  Other [Self funded] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Mohammad Abdullah  Slums of Udupi Taluk  Udupi city urban slums, Kodankur, Balram Nagar, Kodavoor Palekatte, and Indira Nagar.
Udupi
KARNATAKA 
7587522515

abdullak13@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba medical College and Kasturba Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Elderly people from 65 year of age and above  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  65.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Elderly people 65 years of age and above. 
 
ExclusionCriteria 
Details  Elderly people who have signs of Mental retardation and those who will refuse to give their consent. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
The current barriers in accessing the Oral health
Care services among the Elderly living in slums of Udupi taluk. 
8 weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
Factors that affecting the oral health status of Elderly populations in slums such live living conditions, food habits, tobacco usage etc.  12 weeks. 
 
Target Sample Size   Total Sample Size="350"
Sample Size from India="350" 
Final Enrollment numbers achieved (Total)= "185"
Final Enrollment numbers achieved (India)="185" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/03/2020 
Date of Study Completion (India) 20/03/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

With the rapid development of medicine, the number of elderly people, and consequently, elderly patients in dental practice, is constantly increasing. Despite the efforts of dentists to educate patients on oral hygiene (to prevent oral health diseases) there are an increased number of people closely related to the physical- and mental-related quality of life, oral disorders such as tooth loss, interpersonal relationships and daily activities and therefore the “well-being” or “quality of life” the goal of contemporary dentistry is to improve oral health, thus improving the overall quality of patients’ life.

Health is a state of complete physical, mental, and social well-being and not merely the absence of disease and infirmity. From this point of view, the ultimate goal in public health is not only the absence of oral diseases but also the mental and social well-being of patients. Oral health has always been considered an important part of the patient’s general health due to the fact that oral diseases can interfere with daily life activities, thus affecting the general quality of life.

According to the World Health Organization, Oral diseases are the most common noncommunicable diseases (NCDs) and affect people throughout their lifetime, causing pain, discomfort, disfigurement and even death and The oral health care demands are beyond the capacities of the health care systems in most low-and middle-income countries (LMICs) and Social determinants have a strong impact on oral health. The population living in slums belong to the low socioeconomic status. According to Hobdell et al., a strong association exists between dental caries prevalence and poor oral hygiene in people Low socioeconomic status. Another study was done by Kothia et al, says that the two most common oral diseases which are very high in India are the  Prevalence of oral cancer with dental caries in the age group of 35 to 44, and 65 to 74-year- old and respectively periodontal diseases in the age group of 35 to 44, and 65 to 74-year-old. The Global Burden of Disease Study 2016 estimated that oral diseases affected half of the world’s population (3.58 billion people) with dental caries (tooth decay) in permanent teeth being the most prevalent condition assessed. (WHO). Most of the Elderly population in slums are non-working and a study was done by Mishra et al., in 2010 also found caries experiences are more in those who are not having any occupation. Behavioural risk factors for oral diseases are shared with other major NCDs, such as an an unhealthy diet high in free sugars, tobacco use and harmful use of alcohol. (WHO).

In this study most common questionnaire will be used to study and evaluate the oral health-related factors as one of the most comprehensive subjective oral health statuses is to measures the self-reported dysfunction, discomfort, and disability attributed to oral conditions. The questionnaire consists of 20 questions which are related to the barriers and factors related to oral health care. All the participants must fill the questionnaire and their response will be recorded for the purpose to obtain and analyze the results of the study.

 
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