| CTRI Number |
CTRI/2025/05/087340 [Registered on: 22/05/2025] Trial Registered Prospectively |
| Last Modified On: |
21/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Assessment of Oral Lesions in Patients with Pulmonary
Tuberculosis at Tertiary Care Centres in Mumbai Region- A Cross
Sectional Study |
|
Scientific Title of Study
|
Prevalence of Oral Mucosal Lesions in Patients with Pulmonary
Tuberculosis at Tertiary Care Centres in Mumbai Region- A Cross
Sectional Study |
| 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 Yogita Bhujbal |
| Designation |
Post graduate student |
| Affiliation |
1st MDS |
| Address |
MGM dental college and hospital, navi mumbai
MGM dental college and hospital, navi mumbai
Mumbai
MAHARASHTRA
431122
India |
| Phone |
9421669138 |
| Fax |
|
| Email |
yogitabhujbal29@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yogita Bhujbal |
| Designation |
Post graduate student |
| Affiliation |
1st MDS |
| Address |
MGM dental college and hospital, navi mumbai.
Mumbai
MAHARASHTRA
410218
India |
| Phone |
9421669138 |
| Fax |
|
| Email |
yogitabhujbal29@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yogita Bhujbal |
| Designation |
Post graduate student |
| Affiliation |
1st MDS |
| Address |
MGM dental college and hospital, navi mumbai
Mumbai
MAHARASHTRA
410218
India |
| Phone |
9421669138 |
| Fax |
|
| Email |
yogitabhujbal29@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mgm dental college and hospital Navi Mumbai, Maharashtra, india 410218 |
|
|
Primary Sponsor
|
| Name |
No |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
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 Yogita Bhujbal |
Vikas nursing home |
Plot no 18/U/1/2, Baji Prabhu Deshpande Marg, Shivaji Nagar, Govandi East, near Ram Mandir, Govandi Slums, Govandi West, Phase 1, Shivaji Nagar, Mumbai, Maharashtra 400043
Mumbai
MAHARASHTRA |
9421669138
yogitabhujbal29@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional ethis committe mahatma gandhi missions dental college |
Approved |
| Institutional ethis committe mahatma gandhi missions dental college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J708||Respiratory conditions due to other specified external agents, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Newly diagnosed cases of pulmonary tuberculosis not undergone any
treatment for last 6 months.
Patients willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
Any chest diseases other than pulmonary tuberculosis
Past history of radiotherapy
Pregnancy or lactating mothers
Uncooperative/ non-compliant patients
Patients below the age of 18 years |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| 4 weeks |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="384"
Sample Size from India="384"
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)
|
02/06/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
open to recruitment |