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
- 1
- 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).
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)