Prevention of Caries in Head and Neck Cancer Survivors Who Underwent Radiotherapy: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Number of new cavitated caries per each patient (incidence of caries)
研究概览
简要总结
One of the long-term side effects of head and neck radiotherapy (RT) is radiation-induced tooth decay. Hyposalivation, associated with radiation therapy, further increases caries susceptibility and caries progression, due to the lack of salivary protective effects and of tooth minerals useful for remineralization processes, especially calcium phosphate (CaP). Dental extractions that could be required in case of severe tooth decay expose the patient to the risk of osteoradionecrosis of the jaws (i.e. the necrosis of the bone tissue following a local trauma, including surgical trauma). This protocol aims at verifying the effectiveness of CaP mousse in the prevention of carious lesions, added to topical fluoride. A randomized controlled clinical trial will be performed comparing CaP + fluoride treatment versus no treatment in head and neck cancer patients, who received radiotherapy. The hypothesis is that CaP, which is lacking in the mouth of these patients due to hyposalivation, can combine with fluoride to promote remineralization, reducing the risk of carious lesions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- 否
入选标准
- •previous head and neck radiotherapy for oncological treatment
排除标准
- •complete edentulism
- •pregnancy or breastfeeding
研究组 & 干预措施
CaP + Fluoride
Irradiated head and neck cancer patients receiving topical CaP mousse to be applied at home (once a day for the first 3 months, then once a day for one week per month as maintenance), besides topical fluoride (F) in form of professional varnishes (every 6 months) and home products (once a day oral rinse with F mouthwash; three times a day toothpaste with brushing).
干预措施: Application of CaP dental mousse (Other)
Only fluoride
Irradiated head and neck cancer patients receiving only topical fluoride (F) in form of professional varnishes (every 6 months) and home products (once a day oral rinse with F mouthwash; three times a day toothpaste with brushing). Topical fluoride is included in the standard of care, according to national and international guidelines.
结局指标
主要结局
Number of new cavitated caries per each patient (incidence of caries)
时间窗: Assessment every 3 months up to 2 years
Identification of new carious lesion using International Caries Detection and Assessment System from score 0 initial lesions to 6 large cavitated lesions (ICDAS; 4-6)
次要结局
- Number of patients with a diagnosis of osteoradionecrosis (incidence of osteoradionecrosis)(Assessment every 3 months up to 2 years)
- Rate of dentinal hypersensitivity per patient(Assessment every 12 months up to 2 years)
- Rate of bleeding gingival sites per patient(Assessment every 3 months up to 2 years)
- Number of extracted teeth per patient (incidence of extracted teeth)(Assessment every 3 months up to 2 years)
- Number of dental surfaces with caries or filling, and missed teeth(Assessment every 3 months up to 2 years)
- Rate of dental surface with plaque per patient(Assessment every 3 months up to 2 years)
研究者
Elena Varoni
Associate Professor
University of Milan