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CTRI Number  CTRI/2025/03/081620 [Registered on: 04/03/2025] Trial Registered Prospectively
Last Modified On: 27/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Public views on Oral health and Dental care. 
Scientific Title of Study   Public Perception of Oral Health and Dental Care: A Cross-Sectional Study on Knowledge, Awareness, Attitudes, Behavioral Practices, Barriers, and Utilization. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prerana Tripathy 
Designation  Student 
Affiliation  Prasanna School Of Public Health. 
Address  Department of Healthcare and Hospital Management, Tiger Circle Road, Madhav Nagar, Manipal, Karnataka, India Udupi, Karnataka, 576104

Udupi
KARNATAKA
576104
India 
Phone  7205091736  
Fax    
Email  prerana.psphmpl2023@learner.manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Swathi KS 
Designation  Associate Professor 
Affiliation  Prasanna School Of Public Health. 
Address  Department of Healthcare and Hospital Management, Tiger Circle Road, Madhav Nagar, Manipal, Karnataka, India Udupi, Karnataka, 576104

Udupi
KARNATAKA
576104
India 
Phone  9535102124  
Fax    
Email  swathi.ks@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Prerana Tripathy 
Designation  Student 
Affiliation  Prasanna School Of Public Health. 
Address  Department of Healthcare and Hospital Management, Tiger Circle Road, Madhav Nagar, Manipal, Karnataka, India Udupi, Karnataka, 576104

Udupi
KARNATAKA
576104
India 
Phone  07205091736  
Fax    
Email  prerana.psphmpl2023@learner.manipal.edu  
 
Source of Monetary or Material Support  
Prasanna School Of Public health Department of Healthcare and Hospital Management, Tiger Circle Road, Madhav Nagar, Manipal, Karnataka, India Udupi, Karnataka, 576104  
 
Primary Sponsor  
Name  Prerana Tripathy 
Address  Tiger Circle,Madhav Nagar,Manipal,Karnataka,India,576104 
Type of Sponsor  Other [[Self]] 
 
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 
Dr Prerana Tripathy  PRASANNA SCHOOL OF PUBLIC HEALTH  Department of Healthcare and Hospital Management, Tiger Circle Road, Madhav Nagar, Manipal, Karnataka, India Udupi, Karnataka, 576104
Udupi
KARNATAKA 
07205091736

prerana.psphmpl2023@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
kasturba medical college and kasturba hospital institutional ethics committee-2  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  PERCEPTION OF HEALTHY HUMAN VOLUNTEERS ON ORAL HEALTH AND DENTAL CARE. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  The study included individuals aged 18 years and above, Adults who are mentally sound and capable of comprehending the survey questions and Participants with the ability to understand and respond to the survey in the English language. 
 
ExclusionCriteria 
Details  The study excluded individuals unwilling to participate in the survey, Illiterate individuals and Individuals under the age of 18 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
34 questions related to knowledge, awareness, attitudes, behaviours and utilization of dental care and oral health will be given to each participant, and the outcome will be determined using the data gathered from the questionnaire.  4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
There are no specific intervention or endpoint criteria as this is an observational study focused on public perception on oral health and dental care. The proposed study procedures are non-invasive and do not involve additional tests or interventions beyond the standard practices of the participating healthcare facilities.  4 weeks 
 
Target Sample Size   Total Sample Size="424"
Sample Size from India="424" 
Final Enrollment numbers achieved (Total)= "434"
Final Enrollment numbers achieved (India)="434" 
Phase of Trial   N/A 
Date of First Enrollment (India)   14/03/2025 
Date of Study Completion (India) 30/03/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

AIM: This study aims to investigate the factors influencing individual perceptions of oral health and dental care and how these perceptions impact oral hygiene behaviours.

OBJECTIVES:

To examine the factors that affect attitude towards oral health and dental care.

To analyze the effect of attitude on utilization of oral care services.

SCOPE OF THE STUDY:

This study investigates the key factors that influence individual perceptions of oral health and dental care, focusing on knowledge, awareness, attitudes, behavioral practices, perceived barriers, and utilisation. It examines how these perceptions shape oral hygiene behaviors, including the frequency and quality of dental care utilization, across diverse demographic groups. The study further explores disparities in knowledge and access to dental care, aiming to identify gaps and propose strategies to enhance public awareness, improve attitudes, and promote equitable access to oral health services. The insights gained will be valuable for healthcare providers, policymakers, and educators in designing targeted interventions to improve oral health outcomes. The prospective cross-sectional study was conducted over a four-months period, from October 2024 to January 2025.

Sampling method: The study population consists of individuals aged 18 years and above, who are residents of  India, and can understand the language English. Sample selection will be made using non-random, convenience sampling.

Sample Size Calculation

The required sample size for this study was calculated using the following formula:

Formula, n = Z2P (1-P)/ d2

 

 N

Required sample size.

 Z

Z-score.

95% confidence level, Z ~1.96.

 

 P

p=0.5

 D

Desired margin of error. In this case, it is 5%. 0.05 in decimal form.

 

 n= 1.96*1.96*0.5*0.5/0.05*0.05

Substituting values in the formula, n=384.16,

The round off will make number of participants to be 385 for a 95% confidence interval and 5% margin of error.

Considering a 10% non-response rate, the adjusted number of participants needed would be 424.

The calculated sample size is approximately 384.16, which was rounded up to 385 participants to maintain precision. Accounting for a 10% non-response rate, the final adjusted sample size was determined to be 424 participants.

Inclusion Criteria: The study included individuals aged 18 years and above, Adults who are mentally sound and capable of comprehending the survey questions and Participants with the ability to understand and respond to the survey in the English language.        

Exclusion Criteria: The study excluded individuals unwilling to participate in the survey, Illiterate individuals and Individuals under the age of 18.

Justification for study: Maintaining a healthy smile is only one aspect of oral health; other systemic health concerns such as diabetes, respiratory infections, and cardiovascular disease are closely linked to oral health. In spite of this, a lot of people do not prioritize or fully understand their oral health, which can result in avoidable health problems that can be controlled with routine dental care and early intervention. This study can lower the incidence of associated systemic disorders and advance knowledge of public health by examining how people view oral health. Only 2% of Indians visit their dentist regularly,60% of Indians never visit a dentist in their life. 24% of consumers suffered from toothache in the past year, but only 35% sought treatment from a dentist.1The need to address discrepancies in dental care utilization and attitudes is a significant additional motivation for this research. Diverse demographic groups frequently have different views regarding and degrees of access to dental care depending on their location, social status, or cultural background are also different. Through an analysis of these discrepancies, the research can pinpoint the root causes and provide focused tactics to enhance dental care accessibility and education in marginalized areas.

Tool Used: The study will use a structured questionnaire in the form of a Google Form for data collection. The questionnaire will be developed based on various models available in the existing literature. 

Administration of the Tool: Participants will be selected using contacts from personal and professional networks based on their availability and willingness to take part. Informed consent from the individuals participating in the study will be obtained by providing them with all necessary information, including the study’s purpose and procedures. The questionnaire will be administered in the form of a Google Form to individuals who agree to participate in the study, assessing their perceptions of oral health and dental care. The form will be distributed via direct messages and emails to primary and secondary contacts. The collected data will then be analyzed.

Statistical Analysis: The study will use statistical methods such as descriptive statistics to analyze the demographic details of the respondents. Smart PLS 3.0 and the structural equation modeling (SEM) method will be used to examine the factors affecting attitudes toward oral health and dental care, as well as to analyze the effect of attitude on the utilization of oral care services.

 


 
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