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CTRI Number  CTRI/2023/03/050724 [Registered on: 15/03/2023] Trial Registered Prospectively
Last Modified On: 28/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive
Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Fluoride varnish application for the control of radiation induced dental caries in head and neck cancer patients 
Scientific Title of Study   Comparative evaluation of fluoride varnish versus fluoride varnish with cpp-acp to control the radiation caries among irradiated head & neck cancer patients - a one year randomised controlled trial  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Hitesh kumar sahoo 
Designation  2nd year post-graduate student  
Affiliation  S.C.B. Dental College & Hospital 
Address  At-Thatarisahi,Chauliaganj,Cuttack,P.O.-Nayabazar,P.S.-Chauliaganj
Department of Public Health Dentistry,S.C.B.Dental College and Hospital,P.O./P.S.-Mangalabag,PIN-753001.
Cuttack
ORISSA
753004
India 
Phone  7325905241  
Fax    
Email  hitesh6175@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrUtkal Keshari Mohanty 
Designation  Associate Professor 
Affiliation  S.C.B.Dental College and Hospital,Cuttack 
Address  Department of Public Health Dentistry,S.C.B.Dental College and Hospital,P.O./P.S.-Mangalabag

Cuttack
ORISSA
753001
India 
Phone  9437953285  
Fax    
Email  utkalcommunity@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrUtkal Keshari Mohanty 
Designation  Associate Professor 
Affiliation  S.C.B.Dental College and Hospital,Cuttack 
Address  Department of Public Health Dentistry,S.C.B.Dental College and Hospital,P.O./P.S.-Mangalabag

Cuttack
ORISSA
753001
India 
Phone  9437953285  
Fax    
Email  utkalcommunity@gmail.com  
 
Source of Monetary or Material Support  
Self 
 
Primary Sponsor  
Name  Hitesh kumar sahoo 
Address  Department of public health dentistry,S.C.B. Dental College and Hospital,Mangalabag 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Hitesh Kumar Sahoo  ACHARYA HARIHAR POST GRADUATE INSTITUTE OF CANCER  AT-Department of Radiation Oncology and Department of Dentistry,Acharya Harihar Post Graduate Institute of Cancer,Mangalabag,cuttack,P.O./P.S.-Mangalabag,PIN-753001
Cuttack
ORISSA 
7325905241

hitesh6175@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE SCB DENTAL COLLEGE & HOSPITAL,CUTTACK  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C021||Malignant neoplasm of border of tongue, (2) ICD-10 Condition: C020||Malignant neoplasm of dorsal surface of tongue, (3) ICD-10 Condition: C022||Malignant neoplasm of ventral surface of tongue, (4) ICD-10 Condition: C01||Malignant neoplasm of base of tongue, (5) ICD-10 Condition: C060||Malignant neoplasm of cheek mucosa, (6) ICD-10 Condition: C061||Malignant neoplasm of vestibule ofmouth, (7) ICD-10 Condition: C062||Malignant neoplasm of retromolar area, (8) ICD-10 Condition: C100||Malignant neoplasm of vallecula, (9) ICD-10 Condition: C102||Malignant neoplasm of lateral wallof oropharynx, (10) ICD-10 Condition: C103||Malignant neoplasm of posterior wall of oropharynx, (11) ICD-10 Condition: C101||Malignant neoplasm of anterior surface of epiglottis, (12) ICD-10 Condition: C050||Malignant neoplasm of hard palate, (13) ICD-10 Condition: C051||Malignant neoplasm of soft palate, (14) ICD-10 Condition: C052||Malignant neoplasm of uvula, (15) ICD-10 Condition: C090||Malignant neoplasm of tonsillar fossa, (16) ICD-10 Condition: C091||Malignant neoplasm of tonsillar pillar (anterior) (posterior), (17) ICD-10 Condition: C00||Malignant neoplasm of lip, (18) ICD-10 Condition: C04||Malignant neoplasm of floor of mouth, (19) ICD-10 Condition: C07||Malignant neoplasm of parotid gland, (20) ICD-10 Condition: C08||Malignant neoplasm of other and unspecified major salivary glands, (21) ICD-10 Condition: C03||Malignant neoplasm of gum, (22) ICD-10 Condition: C11||Malignant neoplasm of nasopharynx, (23) ICD-10 Condition: C12||Malignant neoplasm of pyriform sinus, (24) ICD-10 Condition: C13||Malignant neoplasm of hypopharynx, (25) ICD-10 Condition: C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx, (26) ICD-10 Condition: C32||Malignant neoplasm of larynx,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Fluoride varnish  Fluoride varnish will be applied pre-radiotherapy and at 3 months interval till 1 year. 
Intervention  Fluoride varnish with cpp-acp  Fluoride varnish with cpp-acp will be applied pre-radiotherapy and at 3 months interval till 1 year. 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Patients with head and neck cancer who are planning for/undergoing RT with more than 50Gy of radiation, with or without chemotherapy,Patients whose oral cavity lies within the RT field during treatment,Patients of 21 years of age or older,Patients having at least two remaining teeth after oral health clearance,Patients having no known milk allergy,Patients who are able to give informed consent.
 
 
ExclusionCriteria 
Details  Patients who have received RT previously,Patients who are receiving RT for palliative care,Patients with edentulous upper and lower jaws,Patients with a habit of mouth breathing.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
DMFS  Baseline(pre-rt),3 months,6 months,9 months and 12 months 
 
Secondary Outcome  
Outcome  TimePoints 
Schiff score , Patient compliance  Baseline(pre-rt),3 months,6 months,9 months and 12 months 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
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   Phase 4 
Date of First Enrollment (India)   15/03/2023 
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)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details
Modification(s)  
None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

This is a one year prospective two arm parallel randomised controlled trial design.Patient’ll be recruited from the OPD (Out Patient Department) of department of Radiation oncology of Acharya Harihar Post Graduate Institute of Cancer (AHPGIC),Cuttack.Patients with head and neck cancer who are planning for/undergoing RT with more than 50Gy of radiation, with or without chemotherapy, those whose oral cavity lies within the RT field during treatment, 21 years of age or older, having at least two remaining teeth after oral health clearance, having no known milk allergy and who are able to give informed consent will be included in the study.Patients who have received RT previously or receiving RT for palliative care,  those with edentulous upper and lower jaws and those with a habit of mouth breathing will be excluded from the study. Information regarding the socio demographic profile, tumor location, staging, histopathology, radiation dosage, and surgery, oral hygiene habits, relevant medical history, dental history, baseline recordings and follow up recordings of parameters will be collected using a validated patient intake and follow-up questionnaire proforma . Preradiotherapy, followup decayed-missing-filled-tooth Index (DMFT), dental sensitivity, and compliance to three-month FVA will be recorded till one year followup and oral health status of the participant will be recorded using WHO oral health survey proforma 2013.  After oral prophylaxis , slow release aqueous-based topical 5% NaF varnish (Fluoritop- SR, ICPA Health Products Ltd. Mumbai, India) will be applied to one group and  5% NaF varnish enhanced with 2% RECALDENT (CPP-ACP) [MI Varnish, GC India private Ltd. Maharastra, India] will be applied to another group. Statistical Analysis of the data recorded will be done using Statistical Package for the Social Sciences version 27.0 (IBM Corp. Released 2020. IBM SPSS Statistics for Windows, Version 27.0. Armonk, NY: IBM Corp). A p≤0.05 will be considered significant for all statistical inferences.

 
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