| 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
|
|
|
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
|
|
|
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
|
|
|
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. |