| 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
|
|
|
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
|
|
|
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
- 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).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Clinical Study Report
- 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.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - through mail
- 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.
- 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.
|