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CTRI Number  CTRI/2024/11/077167 [Registered on: 21/11/2024] Trial Registered Prospectively
Last Modified On: 20/11/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry
Behavioral 
Study Design  Other 
Public Title of Study   Empowering Rural and Remote Communities: The Role of Dental Students in Advancing Tobacco Cessation 
Scientific Title of Study   Enhancing Tobacco Cessation in Rural and Remote Areas: The Impact of Dental Students-Led Community Based Approach 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrK Sri Chaitanya Ram 
Designation  Assistant professor 
Affiliation  Vishnu dental college 
Address  Vishnu dental college Vishnupur Bhimavaram Kovvada Andhra Pradesh 534202

West Godavari
ANDHRA PRADESH
534202
India 
Phone  7337040624  
Fax    
Email  ram.kadiyala24@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrMV Ramesh 
Designation  Associate professor 
Affiliation  Vishnu dental college 
Address  Vishnu dental college Vishnupur Bhimavaram Kovvada Andhra Pradesh 534202

West Godavari
ANDHRA PRADESH
534202
India 
Phone  9949430131  
Fax    
Email  rameshmv@vdc.edu.in  
 
Details of Contact Person
Public Query
 
Name  DrK Sreekar  
Designation  Assistant professor 
Affiliation  Vishnu dental college 
Address  Vishnu dental college Vishnupur Bhimavaram Kovvada Andhra Pradesh 534202

West Godavari
ANDHRA PRADESH
534202
India 
Phone  9959170013  
Fax    
Email  sreekarbds@gmail.com  
 
Source of Monetary or Material Support  
Department of public health dentistry , Vishnu dental college  
 
Primary Sponsor  
Name  Vishnu dental college  
Address  Vishnupur Bhimavaram Kovvada Andhra Pradesh 534202 
Type of Sponsor  Other [Affiliated dental college ] 
 
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 
Ksri chaitanya ram   Vishnu dental college   Department of public health dentistry , 3rd block , Vishnupur, Bhimavaram, Kovvada, Andhra Pradesh 534202
West Godavari
ANDHRA PRADESH 
7337040624

ram.kadiyala24@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Vishnu Dental College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K137||Other and unspecified lesions of oral mucosa,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  placebo  no education  
Intervention  tobacco cessation  intervention group, which will receive oral screening, targeted tobacco cessation education through pamphlets and interactive components, motivational interviewing and cessation techniques  
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  The inclusion criteria for this study involve identifying villages with a high prevalence of smoking and a demonstrated willingness to participate in the research. 
 
ExclusionCriteria 
Details  Non smokers and a demonstrated unwillingness to participate in the research. 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Reduction in tobacco usage
 
12 days  
 
Secondary Outcome  
Outcome  TimePoints 
It enhance the skills of the dental students by incorporating practical, real-world experiences that prepare dental students for broader roles in public health.
 
1 month 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   01/12/2025 
Date of Study Completion (India) Date Missing 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

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

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  through mail

  6. For how long will this data be available start date provided 01-03-2025 and end date provided 01-03-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

The prevalence of cigarette smoking is higher in urban areas but the prevalence of all other smoking products is higher in rural areas. The prevalence of each of the smokeless tobacco product is higher in rural than urban areas. Cessation by tobacco users is the only way to avoid substantial proportion of tobacco-related deaths. Hence, there is an urgent need to bring tobacco cessation to their doorstep and break the social norms which enhance tobacco consumption.

The study will employ a quasi-experimental design with pre- and post-intervention assessments to evaluate the effectiveness of tobacco cessation education provided by dental students in rural and remote villages. The selection criteria for this study involve identifying villages with a high prevalence of smoking and a demonstrated willingness to participate in the research. To ensure robust results, the sample size will include at least 3 villages, with each village contributing 30 participants. This sample size is determined based on power calculations designed to detect significant changes effectively. Then Participants will be divided into an intervention group, which will receive oral screening, targeted tobacco cessation education through pamphlets and interactive components, motivational interviewing and cessation techniques and a control group, which will receive oral screening and standard oral health education. Data collection will involve pre- and post-intervention surveys using pre-designed tested validated questionnaire to assess changes in tobacco use.Additionally,qualitative feedback from participants will provide insights into the intervention’s effectiveness and feasibility.


 
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