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CTRI Number  CTRI/2024/04/065506 [Registered on: 10/04/2024] Trial Registered Prospectively
Last Modified On: 10/04/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Single Arm Study 
Public Title of Study   An educational intervention study to check the knowledge and awareness about the link between diabetes and periodontitis in patients with Type 2 Diabetes Mellitus based on health belief model 
Scientific Title of Study   Evaluation of knowledge and awareness about the bi directional relationship between Diabetes and Periodontitis based on Health Belief Model in patient with Type II Diabetes Mellitus 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shalini Kumari 
Designation  Post graduate student 
Affiliation  KLE Academy of Higher Education and Research 
Address  Department of Periodontics, Department no- 9, Second floor, KAHERs KLE VK Institute of Dental Science, J.N.M.C Campus , Nehru Nagar

Belgaum
KARNATAKA
590010
India 
Phone  8073231684  
Fax    
Email  dr.shalini115@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Menaka Karalwad 
Designation  Professor 
Affiliation  KLE Academy of Higher Education and Research 
Address  Department of Periodontics, Department no- 9, Second floor,KAHERs KLE VK Institute of Dental Science, J.N.M.C Campus , Nehru Nagar

Belgaum
KARNATAKA
590010
India 
Phone  9448268812  
Fax    
Email  menakakaralwad@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Menaka Karalwad 
Designation  Professor 
Affiliation  KLE Academy of Higher Education and Research 
Address  Department of Periodontics, Department no- 9,Second floor, KAHERs KLE VK Institute of Dental Science, J.N.M.C Campus , Nehru Nagar

Belgaum
KARNATAKA
590010
India 
Phone  9448268812  
Fax    
Email  menakakaralwad@rediffmail.com  
 
Source of Monetary or Material Support  
Department of Endocrinology, Dept no- 1, Ground floor, KLEs Dr. Prabhakar Kore Hospital & Research Centre, Nehrunagar,Belagavi, Karnataka- 590010 
 
Primary Sponsor  
Name  Shalini Kumari 
Address  KAHERs KLE Vishwanath Katti Institute of Dental Sciences, Nehru nagar, Belagavi, Karnataka 
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 Vikrant B Ghatnatti  KLEs Dr. Prabhakar Kore Hospital & Medical Research Centre  Department of Endocrinology, Dept no- 1, Ground floor
Belgaum
KARNATAKA 		 9844445598

victorvikrant@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Research and Ethics Committee KLE VKIDS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Educational  Patients will be educated by the use of audio visual presentations of 10 minutes. Patients will be asked to fill questionnaire before and after intervention. 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Patients who are suffering from diabetes and is on medication for same.
Patients above 18 years age.
Patients who signed the informed consent form.
 
 
ExclusionCriteria 
Details  Patients with mental illnesses.
Pregnant and lactating mothers.
Patients with adverse habits.
Participants not willing to participate in the study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Knowledge and awareness in diabetic patients about the bi-directional link between diabetes and periodontitis  At baseline the questionnaire will be given to the patients, then educational intervention will be given in the form of audiovisual aid. Post intervention the questionnaire will be given to the patients immediately. 
 
Secondary Outcome  
Outcome  TimePoints 
Not applicable  not applicable 
 
Target Sample Size   Total Sample Size="125"
Sample Size from India="125" 
Final Enrollment numbers achieved (Total)= "125"
Final Enrollment numbers achieved (India)="125" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   22/04/2024 
Date of Study Completion (India) 31/08/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [dr.shalini115@gmail.com].

  6. For how long will this data be available start date provided 11-03-2024 and end date provided 30-03-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This is an educational interventional study which will be conducted on patients diagnosed with type 2 diabetes. The data collection is done using a valid and reliable questionnaire based on Health Belief Model (HBM) in which the patients fill up the questionnaire pre and post intervention. Educational intervention will be in the form of audio-visual presentation after pre-test assessment. 
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