跳至主要内容
临床试验/CTRI/2025/05/086245
CTRI/2025/05/086245尚未招募不适用

Oral Health Status in patients with Head and Neck Cancer prior to Radiotherapy: A Cross-Sectional Study

Dr. Bhanu Priya3 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2025年5月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
64
试验地点
3
主要终点
assess the oral health status of patients diagnosed with head and neck cancers awaiting radiotherapy.

研究概览

简要总结

Head and neck cancers of the oral cavity, pharynx, and larynx are among the most common types of cancers reported in our country. Tobacco use, particularly smoking and smokeless tobacco consumption, is a significant risk factor. Consumption of tobacco in smokeless form is especially widespread in India and has been linked to oral cancers, which is a significant subset of head and neck  cancer. Radiotherapy, a common treatment for these cancers, is associated with severe oral and dental side effects, such as xerostomia and osteoradionecrosis, which can cause significant morbidity and impact a patient’s quality of life by affecting functions like chewing, swallowing, and speaking. This study aims to assess the oral health status of head and neck cancer patients before radiotherapy, investigate the prevalence of associated risk factors for poor oral health and to assess the treatment outcome on 6 months follow-up basis. The findings could help in developing targeted dental treatment plans to mitigate the adverse effects of radiotherapy, ultimately improving patient outcomes and quality of life. Participants aged 18+ with head and neck cancer, untreated or post-surgery and scheduled for radiotherapy, visiting the Department of Oral Medicine and Radiology, will be recruited after informed consent (English/Kannada). The study protocol will undergo Department, Institutional, and KH Ethics Committee review, with CTRI registration will be done Data collection will include case history, demographics, medical history, oral habits, and standardized oral examination following WHO guidelines. Data will be entered in Excel and analyzed using SPSS v23 with descriptive statistics and Chi-square tests.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • All dentate patients above 18 years of age, diagnosed with head and neck cancer who are untreated or surgically treated and are scheduled for radiotherapy and are willing to participate in the study shall be included.

排除标准

  • ) Patients below 18 years shall be excluded from the study 2) Patients who are not willing to participate in the study shall be excluded 3) Patients suffering from other systemic diseases, who are under long-term medications for systemic illnesses, diagnosed with psychiatric conditions that might affect the participation of the study shall be excluded from the study.

结局指标

主要结局

assess the oral health status of patients diagnosed with head and neck cancers awaiting radiotherapy.

时间窗: Baseline and 6 months

次要结局

  • highlights the risk factors contributing to oral health deterioration in head & neck cancer patients undergoing radiotherapy & evaluates the effectiveness of pre-radiotherapy dental treatment plans in maintaining oral health.(Baseline & 6 months)

研究者

发起方
Dr. Bhanu Priya
申办方类型
Other [Self funded]

研究点 (3)

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