| CTRI Number |
CTRI/2026/02/103068 [Registered on: 05/02/2026] Trial Registered Prospectively |
| Last Modified On: |
04/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
After effect of Chemotherapy in Oral Cavity of Children |
|
Scientific Title of Study
|
Changes of Oral Mucosa in children after Chemotherapy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shweta Shubham |
| Designation |
Post Graduate Trainee |
| Affiliation |
Buddha Institute of Dental Sciences and Hospital |
| Address |
Department of Pediatric and Preventive Dentistry, Buddha Institute of Dental Sciences and Hospital, West of TV Tower, Gandhinagar, Kanti Factory Road, Kankarbagh
Patna
BIHAR
800020
India |
| Phone |
7667966720 |
| Fax |
|
| Email |
shwetaraman2018@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shweta Shubham |
| Designation |
Post Graduate Trainee |
| Affiliation |
Buddha Institute of Dental Sciences and Hospital |
| Address |
Department of Pediatric and Preventive Dentistry, Buddha Institute of Dental Sciences and Hospital, West of TV Tower, Gandhinagar, Kanti Factory Road, Kankarbagh
Patna
BIHAR
800020
India |
| Phone |
7667966720 |
| Fax |
|
| Email |
shwetaraman2018@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shweta Shubham |
| Designation |
Post Graduate Trainee |
| Affiliation |
Buddha Institute of Dental Sciences and Hospital |
| Address |
Department of Pediatric and Preventive Dentistry, Buddha Institute of Dental Sciences and Hospital, West of TV Tower, Gandhinagar, Kanti Factory Road, Kankarbagh
Patna
BIHAR
800020
India |
| Phone |
7667966720 |
| Fax |
|
| Email |
shwetaraman2018@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Buddha Institute of Dental Sciences and Hospital |
| Address |
West of TV Tower, Gandhinagar, Kanti Factory Rd, Kankarbagh, Patna, Bihar 800026 |
| Type of Sponsor |
Other [Private Dental Institute] |
|
|
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 |
| Shweta Subham |
Indira Gandhi Institute of Medical Sciences |
Sheikhpura, Patna, Bihar - 800 014
Patna
BIHAR |
76679 66720
shwetaraman2018@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, IGIMS, Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
All pediatric cancer patients receiving chemotherapy from the department of medical oncology in the state cancer institute, Indira Gandhi Institute of Medical Sciences, Patna.
Frankel behaviour rating 3 or 4 |
|
| ExclusionCriteria |
| Details |
Patients older than 14 years.
Oral cancer patients.
Uncooperative children.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Type of Malignancy
Prevalence of Oral Complications
Scoring of Oral Mucositis Grades
Scoring of Gingival Index scales |
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Scoring of Oral Mucositis Grades
Scoring of Gingival Index scales |
12 months |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
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)
|
15/02/2026 |
| 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="0"
Months="11"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Want to access The changes of oral mucosa which
includes oral mucositis , intra oral infections, dry mouth, salivary gland inflammation
and mucosal bleeding.
|