Comparison of two fluoride application regime on teeth of oral cancer patients, in terms of dental decay prevention and control.
- Conditions
- Malignant neoplasms of lip, oral cavity and pharynx,
- Registration Number
- CTRI/2019/08/020794
- Lead Sponsor
- Cancer Research Institute Swami Rama Himalayan University
- Brief Summary
The present study is a randomized clinical trial comprisingof two groups. The study will be conducted at Cancer Research Institute , SwamiRama Himalayan University Dehradun. Studyaims to access the effect of two different frequency of fluoride application onteeth 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 receiveone monthly fluoride application on teeth or 4 monthly fluoride application. Each group is further divided into 2 equal subgroupwhich will either receive fluoride gel or fluoride varnish randomly. Data willbe collected at baseline , 6 months and one year.
The primary aim of the study is to assess which frequency offluoride application is better in reduction and prevention of dental caries in patientswho have received radiotherapy for oral cancer.
We also aim to standardize our oral care protocol for ourpopulation at our center. We will also be accessing quality of life by collectingdata by form such as; EORTC QL C 30 , EORTCH&N 35, OHIP-14, HADS . Complete Dental examination will be done which willinclude index such as, OHI, DMFT, GI, CAL.
As there is no Indian standard guidelines for oral care incancer patients this study will provide data for formulation of such guidelines.Standardization of our protocol of oral care will provide data for formulationof standardized narional oral care protocol.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 172
- Inclusion criteria: 1.
- Patient with histopathological diagnosis of carcinoma of oral cavity.
- Patient aged 18 years and above 3.
- Gives consent.
- Exclusion criteria: 1.
- Patients with distant metastasis.
- Previously received any kind cancer treatment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method 1. standardisation of oral care protocol for cancer patients. 6 months .
Trial Locations
- Locations (1)
Cancer research institute
🇮🇳Dehradun, UTTARANCHAL, India
Cancer research institute🇮🇳Dehradun, UTTARANCHAL, Indiaabhishek kandwalPrincipal investigator7500600066hod.dental@srhu.edu.in