| CTRI Number |
CTRI/2026/04/109234 [Registered on: 23/04/2026] Trial Registered Prospectively |
| Last Modified On: |
22/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Can Telephone Support Help People Who Use Chewing Tobacco to Quit? Evidence from Odisha |
|
Scientific Title of Study
|
Effectiveness of National Tobacco Quitline Services (NTQLS) in cessation among smokeless tobacco (SLT) users: A randomised controlled trial in Tertiary care Hospital, Odisha |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr SATYAPRABHA ROUT |
| Designation |
MDS 1ST YEAR |
| Affiliation |
SCB DENTAL COLLEGE AND HOSPITAL,CUTTACK,ODISHA, Odisha |
| Address |
PUBLIC HEALTH DENTISTRY,SCB DENTAL COLLEGE AND HOSPITAL,MANGALABAG, CUTTACK, ODISHA, 753007,INDIA
Cuttack
ORISSA
753007
India |
| Phone |
8144644868 |
| Fax |
|
| Email |
satyaprabha2016@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr UTKAL KESHARI MOHANTY |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
SCB DENTAL COLLEGE AND HOSPITAL,CUTTACK,ODISHA, Odisha |
| Address |
DEPT OF PUBLIC HEALTH DENTISTRY, SCB DENTAL COLLEGE AND HOSPITAL, MANGALABAG, CUTTACK, ODISHA, 753007, INDIA
Cuttack
ORISSA
753007
India |
| Phone |
9437953285 |
| Fax |
|
| Email |
utkalcommunity@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr HEMAMALINI RATH |
| Designation |
HEAD OF THE DEPARTMENT AND PROFESSOR |
| Affiliation |
SCB DENTAL COLLEGE AND HOSPITAL,CUTTACK,ODISHA, Odisha |
| Address |
DEPT OF PUBLIC HEALTH DENTISTRY, SCB DENTAL COLLEGE AND HOSPITAL, MANGALABAG, CUTTACK,ODISHA,753007, INDIA
Cuttack
ORISSA
753007
India |
| Phone |
9437225245 |
| Fax |
|
| Email |
hema_hr@rediffmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr SATYAPRABHA ROUT |
| Address |
SCB DENTAL COLLEGE AND HOSPITAL, MANGALABAG,CUTTACK,ODISHA,753007 |
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| Dr SATYAPRABHA ROUT |
SCB DENTAL COLLEGE AND HOSPITAL |
TOBACCO CESSATION CENTER ,SCB DENTAL COLLEGE AND HOSPITAL
MANGALABAG, CUTTACK, ODISHA, 753007, INDIA
Cuttack
ORISSA |
08144644868
satyaprabha2016@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE SCB DENTAL COLLEGE AND HOSPITAL CUTTACK,ODISHA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
SMOKELESS TOBACCO USERS |
| Patients |
(1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
BEHAVIOURAL COUNSELLING |
At baseline, participants will receive behavioural counselling delivered by principal investigator and will be followed up at 4, 8, 12, and 24 weeks, with additional self help information brochures to reinforce cessation efforts. |
| Intervention |
BEHAVIOURAL COUNSELLING |
Participants will be given a brief advice on harmful effect of tobacco and enrolled in the National Tobacco Quitline Services (NTQLS) through the designated toll-free number 1800-11-2356 with supplementary information brochure. Follow-up assessments will be conducted at 4, 8, 12, and 24 weeks to evaluate their utilization of the service. During each follow-up, participants will be asked to report whether they received proactive and reactive calls from the NTQLS. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of all age groups referred to TCC of SCB Dental College and Hospital, Cuttack will be included in the study.
2.Individuals who are current users of smokeless tobacco products (such as gutkha, khaini, pan masala with tobacco, snuff, or other forms).
3.Individuals who are willing to quit smokeless tobacco.
4.Individuals willing to participate in the cessation intervention.
|
|
| ExclusionCriteria |
| Details |
1.Individuals who consume or use smoked tobacco products only (cigarettes/bidis) without smokeless tobacco use.
2.Individuals who are currently enrolled in any other tobacco cessation program or clinical trial.
3.Individuals receiving pharmacotherapy for tobacco cessation (nicotine replacement therapy, bupropion, varenicline, or other medications) at the time of recruitment.
4.Individuals with serious medical illnesses or unstable systemic conditions that may interfere with participation or follow-up (e.g., severe cardiac disease, uncontrolled diabetes, or malignancy).
5.Individuals with psychiatric disorders or cognitive impairment that limit their ability to provide reliable information or informed consent.
6.Individuals who are not willing to provide informed consent or unable to comply with the study protocol and scheduled follow-up visits.
7.Participants who plan to relocate or are unlikely to be available for the 24-week follow-up period
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Point prevalence abstinence from smokeless tobacco use at 4,8,12,24 weeks |
4,8,12,24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Prolonged abstinence (continuous cessation) over a period of 24 weeks
2.Number and frequency of quit attempts
3.Proportion of participants with relapse
4.Salivary cotinine level assessment at the end of 24 weeks.
|
6 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="264"
Sample Size from India="264"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/07/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
This study evaluates the effectiveness of National Tobacco Quitline Services (NTQLS) in helping smokeless tobacco users quit. It is a randomized controlled trial conducted among 264 participants at a tertiary care hospital in Odisha, comparing behavioural counselling alone with counselling plus quitline support. Participants will be followed for 24 weeks to assess abstinence, quit attempts, and relapse. The findings aim to determine whether NTQLS improves cessation outcomes and can serve as an effective, accessible public health strategy for tobacco control.
|