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CTRI Number  CTRI/2024/05/067984 [Registered on: 28/05/2024] Trial Registered Prospectively
Last Modified On: 24/12/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   A study to evaluate oral and dental needs in treated head and neck cancer survivor participants 
Scientific Title of Study   A cross-sectional observational study to evaluate oral and dental needs in treated head and neck cancer survivors 
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 Madhura Sharma 
Designation  Assistant Professor 
Affiliation  Advanced Centre for Treatment Research and Education in Cancer ACTREC 
Address  Dental Services, RRS Ground Floor, Room No 31, ACTREC, Sector 22, Utsav Chowk - CISF Rd, Owe Camp, Kharghar, Navi Mumbai, Maharashtra 410210
Sector 22, Utsav Chowk - CISF Rd, Owe Camp, Kharghar, Navi Mumbai, Maharashtra 410210
Raigarh
MAHARASHTRA
410210
India 
Phone  09096046257  
Fax    
Email  sharmamadhura10@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Madhura Sharma 
Designation  Assistant Professor 
Affiliation  Advanced Centre for Treatment Research and Education in Cancer ACTREC 
Address  Dental Services, RRS Ground Floor, Room No 31, ACTREC, Sector 22, Utsav Chowk - CISF Rd, Owe Camp, Kharghar, Navi Mumbai, Maharashtra 410210
Sector 22, Utsav Chowk - CISF Rd, Owe Camp, Kharghar, Navi Mumbai, Maharashtra 410210
Raigarh
MAHARASHTRA
410210
India 
Phone  09096046257  
Fax    
Email  sharmamadhura10@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Madhura Sharma 
Designation  Assistant Professor 
Affiliation  Advanced Centre for Treatment Research and Education in Cancer ACTREC 
Address  Dental Services, RRS Ground Floor, Room No-31, ACTREC, Sector 22, Utsav Chowk - CISF Rd, Owe Camp, Kharghar, Navi Mumbai, Maharashtra 410210
Sector 22, Utsav Chowk - CISF Rd, Owe Camp, Kharghar, Navi Mumbai, Maharashtra 410210
Raigarh
MAHARASHTRA
410210
India 
Phone  09096046257  
Fax    
Email  sharmamadhura10@gmail.com  
 
Source of Monetary or Material Support  
Advanced Centre for Treatment, Research and Education in Cancer (ACTREC) Tata Memorial Centre 
Tata Memorial Hospital (TMH) Tata Memorial Centre 
 
Primary Sponsor  
Name  Advanced Center for Cancer Treatment Research and Education in Cancer ACTREC Tata Memorial Center 
Address  Plot No. 1& 2, Sector 22 Kharghar, Navi Mumbai - 410210. Maharashtra, India. 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Madhura Sharma  Advance Centre for Treatment Research and Education in Cancer (ACTREC) Tata Memorial Center  Dental Services, RRS Ground Floor,Room No 31, ACTREC, Sector 22, Utsav Chowk - CISF Rd, Owe Camp, Kharghar, Navi Mumbai, Maharashtra 410210
Raigarh
MAHARASHTRA 
09096046257

sharmamadhura10@gmail.com 
Dr Madhura Sharma  Tata Memorial Hospital (TMH) Tata Memorial Center  Dental and Prosthetic Surgery Department, HBB Room No 217, TMH , Dr. E Borges Road, Parel, Mumbai - 400 012 India
Mumbai
MAHARASHTRA 
09096046257

sharmamadhura10@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee III , TMC-ACTREC   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C00-D49||Neoplasms,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  All consenting patients, 18 or more than 18 years of age, reporting in the Dental and Prosthetic Surgery Department at TMH and ACTREC for post-treatment follow-up check-ups will be enrolled in this study. The patients should have completed at least 1 year since the last dose of radiotherapy.  
 
ExclusionCriteria 
Details  The patients refusing to provide consent for the study. Patients who have not completed one year of the HNC treatment. Patients reporting with recurrence and/or secondary malignancies. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Recording dental and oral dental treatment needs  Single Time point
Post head and neck cancer treatment 
 
Secondary Outcome  
Outcome  TimePoints 
Quality of Life  Single time point
Post head and neck cancer treatment 
 
Target Sample Size   Total Sample Size="360"
Sample Size from India="360" 
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)   15/06/2024 
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)
Modification(s)  
Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

The head and neck cancer burden in India has increased substantially in recent times. The recent advances in treatment of cancer have led to increase in the survivorship. However, oral complications resulting from cancer and cancer therapies cause acute and late toxicities that may be underreported, underrecognized, and undertreated. With the increase in the life expectancy; the patient’s desire to have a optimal long-term oral health and general well-being. have also increased substantially. The oral and dental health status plays a very important role for maintaining a good quality of life assisting in mastication and swallowing of food. Although some of the acute oral toxicities of cancer therapies may be reduced, they remain essentially unavoidable. The complications associated with HNC treatment many a times lead to patients being dental cripples with inability to have a normal diet. Prevention and management are best provided via multidisciplinary health care teams, which must be integrated and communicate effectively in order to provide the best patient care in a coordinated manner at the appropriate time. This study plans to evaluate the probable long-term effects of HNC treatment on oral and dental health status in a tertiary health care center.  The resultant conclusions will help in maintaining, treating and rehabilitating HNC patients for dental professionals.

 
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