To test saliva and compare anti-caries agents for prevention of radiation caries among Head and Neck cancer patients undergoing radiotherapy.

Phase 1

Not yet recruiting

Conditions: Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx,

Registration Number: CTRI/2019/03/017977

Lead Sponsor: Nitte Deemed to be University

Brief Summary: Every year an increase of head and neck malignancy patients arediagnosed all over the world.Radiotherapy (RT) is the most preferred treatment choice howeverit is associated with many undesired side effects.RT effects the salivaryglands resulting in changes in the oral flora favouring cariogenic organismsand an increased susceptibility to caries.Irradiated patients are at increased risk for development of arapid, rampant carious process known as radiation caries.Dentalcaries in patients undergoing radiotherapy may develop fast, as early as 3monthâ€™s post radiation. Lesions typically in the cervical third of tooth.Preventionis far more important than its treatment due to the complex anatomy of thedentin on root surfaces which is far more soluble than enamel, as a result rootcaries lesions may progress at rapid rate compared to coronal caries.However,the precise incidence and prevalence of radiotherapy induced side effects androot caries sequelae are still to be obtained as it is one of the most commonoccurrence post radiation.

Hence the aim of this study is t*o assess the nature of salivafor subjects undergoing radiation therapy bydetermining the quantity and quality of saliva before beginning radiation,during and post therapy in each study group.*

We also want to evaluatethe effect of three anti-caries agents like a fluoride containing toothpaste,virgin coconut oil rinse and a Calcium Phosphopeptide - AmorphousCalcium Phosphate (CPP-ACP) containing tooth cream to be used on a daily basisamong *subjects* undergoing radiotherapy forhead and neck cancers.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 150

Inclusion Criteria

Patients diagnosed with head and neck cancer.
Patients undergoing radiotherapy with IMRT -older than 12 years old age.

Exclusion Criteria

Patients not undergoing radiotherapy -stage III and stage IV patients with trismus having restricted mouth opening -patients undergoing surgery -patients undergoing chemotherapy -patients suffering from other systemic conditions -Subjects those who have history of allergy to oil use.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
root caries index (RCI) for each subject will be calculated	To compare the changes in root caries index between the study groups at the 1st week, 6th ,12th and 24th week. (before and after radiotherapy)

Secondary Outcome Measures

Name	Time	Method
To compare the quantity and quality of saliva between the study groups using saliva kits.	To compare the quantity and quality of saliva between the study groups at the 1st week, 6th ,12th and 24th week.

Trial Locations

Locations (1): A.B.Shetty Memorial Institute of Dental Sciences
🇮🇳
Kannada, KARNATAKA, India
A.B.Shetty Memorial Institute of Dental Sciences
🇮🇳Kannada, KARNATAKA, India
UPASANA REDDY
Principal investigator
9845827259
upasana.reddy.88@gmail.com