Cross-Sectional Study of Oral Health in Patients After Parotid-Sparing Radiation Therapy for Head and Neck Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- prevalence of dental caries in patients after PS-IMRT
研究概览
简要总结
The investigators are conducting research about oral health and saliva to find out more about the impact of radiation therapy on the oral health of patients.
In order to better understand the role of saliva in maintaining oral health in these patients, the investigators will be collecting, storing, and analyzing the quality of saliva, including the protein content, collected from patients following radiation therapy as well as saliva collected from normal healthy adults.
详细描述
Radiation-induced xerostomia is the most common long term complication of head and neck radiation, is usually permanent and is the most frequent reason for reduced quality of life in these patients. The loss of antimicrobial, buffering, cleansing and remineralizing effects of saliva markedly increases the risk for dental caries. Extractions of diseased teeth located in irradiated bone and dental infection involving the bone can trigger osteoradionecrosis (ORN), another serious complication of high dose radiation of the jaws. Therefore, current dental treatment guidelines recommend the extraction of diseased teeth and any teeth that might require extraction in the future, before radiation therapy. (NCI, 1990; Rankin et al, 2003; NIDCR, 2005) As a result, patients with head and neck cancer often have many or all teeth extracted, especially those patients who are judged unlikely to comply with lifelong, daily topical fluoride, oral hygiene practices and frequent professional dental care. (Bruins et al, 1999)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All subjects who have been enrolled in a parotid-sparing IMRT protocol for head and neck cancer at University of Michigan.
- •At least 6 months has elapsed since the completion of RT, at the time of assessment for this study.
- •All subjects must sign a University of Michigan Health System- IRB approved informed consent.
- •Documented Karnofsky performance status > 60
- •These subjects will all have American Joint Committee on Cancer (AJCC) Stage III or Stage IV disease. (Green et al, 2001) (Appendix 2); non-metastatic, curable disease
排除标准
- •History of surgical removal of major salivary gland(s).
- •Patients edentulous prior to radiation therapy.
- •Pregnancy or lactation
- •Patients residing in prison.
- •Age< 18 years.
结局指标
主要结局
prevalence of dental caries in patients after PS-IMRT
时间窗: 24 Months
Various surveys and questionnaires administered for data collection as well as potential risk indicators for dental caries. Oral examination and saliva specimins collected will determine acid, plaque and exposure to tobacco products
prevalence of tooth loss in patients after PS-IMRT
时间窗: 24 months
Various surveys and questionnaires administered for data collection as well as potential risk indicators for dental caries. Oral examination and saliva specimins collected will determine acid, plaque and exposure to tobacco products
次要结局
- prevalence of periodontal disease after PS-IMRT(24 Months)
研究者
Avraham Eisbruch
Newman Family Professor of Radiation Oncology and Professor of Radiation
University of Michigan Rogel Cancer Center