Evaluation of saliva and comparison of anti-caries agents for prevention of radiation caries among Head and Neck cancer patients undergoing radiotherapy - an invivo study.
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- root caries index (RCI) for each subject will be calculated
研究概览
简要总结
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 3month’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 to 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Adaptive randomization, such as minimization
- 盲法
- Open Label
入排标准
- 年龄范围
- 12.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients diagnosed with head and neck cancer.
- •Patients undergoing radiotherapy with IMRT -older than 12 years old age.
排除标准
- •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.
结局指标
主要结局
root caries index (RCI) for each subject will be calculated
时间窗: 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)
次要结局
- 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.)