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CTRI Number  CTRI/2019/08/020794 [Registered on: 20/08/2019] Trial Registered Prospectively
Last Modified On: 13/04/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Preventive
Dentistry
Process of Care Changes 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of two fluoride application regime on teeth of oral cancer patients, in terms of dental decay prevention and control. 
Scientific Title of Study   Comparison of two fluoride application regime in oral cancer patients. A Randomized 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  Abhishek Kandwal  
Designation  Associate Professor & Head Dental Surgery 
Affiliation  Cancer Research Institute, Swami Rama Himalayan University  
Address  Department of Dental surgery. Cancer Research Institute. Himalayan Institute of Medical Sciences. Swami Rama Himalayan University Swami Ram Nagar , Jolly grant

Dehradun
UTTARANCHAL
248016
India 
Phone  7500600066  
Fax    
Email  abhishekkandwal@srhu.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Abhishek Kandwal  
Designation  Associate Professor & Head Dental Surgery 
Affiliation  Cancer Research Institute, Swami Rama Himalayan University  
Address  Department of Dental surgery. Cancer Research Institute. Himalayan Institute of Medical Sciences. Swami Rama Himalayan University Swami Ram Nagar , Jolly grant

Dehradun
UTTARANCHAL
248016
India 
Phone  7500600066  
Fax    
Email  abhishekkandwal@srhu.edu.in  
 
Details of Contact Person
Public Query  
Name  Abhishek Kandwal  
Designation  Associate Professor & Head Dental Surgery 
Affiliation  Cancer Research Institute, Swami Rama Himalayan University  
Address  Department of Dental surgery. Cancer Research Institute. Himalayan Institute of Medical Sciences. Swami Rama Himalayan University Swami Ram Nagar , Jolly grant

Dehradun
UTTARANCHAL
248016
India 
Phone  7500600066  
Fax    
Email  abhishekkandwal@srhu.edu.in  
 
Source of Monetary or Material Support  
Cancer Research Institute, Swami Rama Himalayan University Dehradun. 
 
Primary Sponsor  
Name  Cancer Research Institute Swami Rama Himalayan University 
Address  Cancer Research Institute. Swami Rama Himalayan University Swami Ram Nagar , Jolly grant 248016  
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 = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
abhishek kandwal  Cancer research institute   cancer research institute , swami rama himalayan university , swami ram nagar, jolly grant., dehradun 248016
Dehradun
UTTARANCHAL 		 7500600066

hod.dental@srhu.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ETHICS COMMITEEE SWAMI RAMA HIMALAYAN UNIVERSITY   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Fluoride Gel/Varnish  1. Site : On clean dried tooth surfaces 2. Duration : 4 minutes. 3. Dose: a) Gel: 2-3 ml in disposable tray ( Fluocal Gel Septodent) b) Varnish: 1.5 ml by paint on method ( Fluoritop SR ICPA) 4. Frequency: Monthly. 
Comparator Agent  Fluoride Varnish/Gel.  1. Site : On clean dried tooth surfaces 2. Duration : 4 minutes. 3. Dose: a) Gel: 2-3 ml in disposable tray ( Fluocal Gel Septodent) b) Varnish: 1.5 ml by paint on method ( Fluoritop SR ICPA) 4. Frequency: Once in four months.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Inclusion criteria:
1. Patient with histopathological diagnosis of carcinoma of oral cavity.
2. Patient aged 18 years and above
3. Gives consent
 
 
ExclusionCriteria 
Details  Exclusion criteria:
1. Patients with distant metastasis.
2. Previously received any kind cancer treatment.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Comparison of the impact of two fluoride application regime on caries development in patients receiving radiation therapy for oral cancer.   1.baseline
2. after 6 months
3. after one year  
 
Secondary Outcome  
Outcome  TimePoints 
1. standardisation of oral care protocol for cancer patients.   6 months . 
 
Target Sample Size   Total Sample Size="172"
Sample Size from India="172" 
Final Enrollment numbers achieved (Total)= "111"
Final Enrollment numbers achieved (India)="111" 
Phase of Trial   N/A 
Date of First Enrollment (India)   26/08/2019 
Date of Study Completion (India) 27/04/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 27/04/2022 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 1. Kandwal A, Saini S, Ahmad M, Nautiyal V, Pattanayak M, Raj D, Takao U. Validation of a Novel ‘Supportive Oral Care Protocol’(SOCP), a Model for Care in Head and Neck Cancer Patients at Tertiary Cancer Centre in India. Indian Journal of Surgical Oncology. 2020 Dec;11(4):769-77. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

The present study is a randomized clinical trial comprising of two groups. The study will be conducted at Cancer Research Institute , Swami Rama Himalayan University  Dehradun. Study aims to access the effect of two different frequency of fluoride application on teeth of patients who have receive radiotherapy for oral cancer .

It is a single center study with total of 172 patients, which will be divided into two equal groups randomly. Each group will either receive one monthly fluoride application on teeth or 4 monthly fluoride application.  Each group is further divided into 2 equal subgroup which will either receive fluoride gel or fluoride varnish randomly. Data will be collected at baseline , 6 months and one year.

 

The primary aim of the study is to assess which frequency of fluoride application is better in reduction and prevention of dental caries in patients who have received radiotherapy for oral cancer.

 

We also aim to standardize our oral care protocol for our population at our center. We will also be accessing quality of life by collecting data  by form such as; EORTC QL C 30 , EORTC H&N 35, OHIP-14, HADS . Complete Dental examination will be done which will include index such as, OHI, DMFT, GI, CAL.

As there is no Indian standard guidelines for oral care in cancer patients this study will provide data for formulation of such guidelines. Standardization of our protocol of oral care will provide data for formulation of standardized narional oral care protocol.

 
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