| 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 |
|
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Source of Monetary or Material Support
|
|
|
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
|
|
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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 |
|
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Regulatory Clearance Status from DCGI
|
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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.
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| DMFS |
Baseline(pre-rt),3 months,6 months,9 months and 12 months |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Schiff score , Patient compliance |
Baseline(pre-rt),3 months,6 months,9 months and 12 months |
|
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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. |