Accompaniment of Patients by Dental Assistants in the Evaluation of Oral Hygiene During and After Radiotherapy Treatment: a Feasibility Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Rate of patients with improved oral hygiene between the inclusion visit and 3 months post-radiotherapy.
研究概览
简要总结
Feasibility, prospective, monocentric study aiming to evaluate the interest of a written information guide, given and explained by the dental assistant, on the improvement of the oral hygiene of patients with ORL cancer at 3 months post-radiotherapy.
The study will be conducted on a population of 44 patients with ORL cancer requiring radiation treatment.
Each patient will be followed during 3 months post-radiotherapy (follow-up for up to 12 months post-inclusion).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Age ≥ 18 years at study entry.
- •Patient with ORL cancer requiring radiotherapy (+/- associated chemotherapy).
- •Patient with a plaque index > or = 30%.
- •Patient affiliated to a social security system in France.
- •Patient having signed informed consent prior to inclusion in the study and prior to any specific procedure for the study.
排除标准
- •Pregnant or lactating women.
- •Any psychological, familial, geographic or sociological condition that does not allow for compliance with the medical follow-up and/or procedures outlined in the study protocol.
- •Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).
研究组 & 干预措施
Patients with ORL cancer for which radiotherapy treatment is required.
干预措施: Accompaniment by the dental assistant. (Other)
结局指标
主要结局
Rate of patients with improved oral hygiene between the inclusion visit and 3 months post-radiotherapy.
时间窗: 3 months per patient
Improvement is defined as a gross decrease of at least 30% in the plaque index between the inclusion visit and 3 months post-radiotherapy. The plaque index will be evaluated using the O'Leary method.
次要结局
- Patient satisfaction with the oral hygiene information guide and the consultations performed by the dental assistant.(3 months per patient)
- The motivation of the patients towards their oral health.(3 months per patient)