Tolerance of Teeth Brushing During Prolonged Aplasia In Protected Unit
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Highest score obtained at the OAG (Oral Assessment Guide) scale during the observation period
研究概览
简要总结
It is currently not allowed for patients with prolonged aplasia, following intensive chemotherapy, to brush teeth due to the risk of damaging the oral mucosa with risk of haemorrhage and infectious entrance door. Mouthwash is currently prescribed to prevent these complications. Many patients, however, ask to brush their teeth for greater comfort and a feeling of well-being.
Some haematology services allow tooth brushing while others prohibit tooth brushing without study.
Investigators wanted to conduct a study to assess the feasibility, the safety of tooth brushing for aplastic patient comfort, hemopathy and/or chemotherapies causing mucous membrane alteration that increases infectious risk and the risk of gingivorragia.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- 否
入选标准
- •Hospitalized Patients in protected area of the Blood Disease Service with predictable prolonged aplasia and risk of mucite
- •Acute myeloblastic leukemia undergoing induction or consolidation treatment
- •Acute lymphoblastic leukemia under induction treatment
- •Patients affiliated or beneficiaries of a social security
- •Written inform consent
排除标准
- •Patients with removable complete dentures
- •Constitutional disorder of coagulation
- •Hematopoietic stem cell allogreffe
- •Therapeutic intensification with autograft of haematopoietic stem cells
- •Patient unable to provide oral care alone (brushing teeth or mouthwash)
- •Already included in the study
- •Pregnant women, lactating mothers
- •Persons deprived of liberty by an administrative or judicial decision
- •Persons undergoing psychiatric care under duress
- •Adults who are subject to a legal or non-state protection measure to express their consent
研究组 & 干预措施
Tooth brushing
干预措施: Toothbrush (Device)
Mouthwash
干预措施: Mouthwashes (Drug)
结局指标
主要结局
Highest score obtained at the OAG (Oral Assessment Guide) scale during the observation period
时间窗: 1 month
Assess the effect of the "teeth brushing" versus "mouth bath" strategy on the oral condition of patients hospitalized in the protected area of the Blood Disease Service with predictable prolonged aplasia and risk of mucite
次要结局
- Number of days with intra-oral hemorrhage(1 month)
- Percentage of patients receiving parenteral nutrition during hospitalization(1 month)
- Percentage of patients receiving morphinics during hospitalization(1 month)
- Number of days with morphinic treatment(1 month)
- Number of days with parenteral nutrition(1 month)
- Percentage of patients who had to discontinue treatment on medical advice(1 month)
- Number of days with fever(1 month)
- Incidence of bacterial infections during hospitalization(1 month)
- Number of septicemia(1 month)
- Incidence of intra-oral hemorrhage(1 month)
- Incidence of fungal infections during hospitalization(1 month)