Fluoride varnish application for the control of radiation induced dental caries in head and neck cancer patients

Phase 4

Not yet recruiting

Registration Number: CTRI/2023/03/050724

Lead Sponsor: Hitesh kumar sahoo

Brief Summary: This is a one year prospective two arm parallel randomised controlled trial design.Patientâ€™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*â‰¤0.05 will be considered significant for all statistical inferences.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 72

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
DMFS	Baseline(pre-rt),3 months,6 months,9 months and 12 months

Secondary Outcome Measures

Name	Time	Method
Schiff score , Patient compliance	Baseline(pre-rt),3 months,6 months,9 months and 12 months

Trial Locations

Locations (1): ACHARYA HARIHAR POST GRADUATE INSTITUTE OF CANCER
🇮🇳
Cuttack, ORISSA, India
ACHARYA HARIHAR POST GRADUATE INSTITUTE OF CANCER
🇮🇳Cuttack, ORISSA, India
Hitesh Kumar Sahoo
Principal investigator
7325905241
hitesh6175@gmail.com