Tolerance of Teeth Brushing During Prolonged Aplasia
- Conditions
- Aplasia
- Interventions
- Drug: MouthwashesDevice: Toothbrush
- Registration Number
- NCT03879252
- Lead Sponsor
- University Hospital, Angers
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 80
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mouthwash Mouthwashes - Tooth brushing Toothbrush -
- Primary Outcome Measures
Name Time Method Highest score obtained at the OAG (Oral Assessment Guide) scale during the observation period 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
- Secondary Outcome Measures
Name Time Method Number of days with intra-oral hemorrhage 1 month Estimate the effect of the strategy in terms of Hemorrhagic risk
Number of days with fever 1 month Estimate the effect of the strategy in terms of Infectious risks
Incidence of bacterial infections during hospitalization 1 month Estimate the effect of the strategy in terms of Infectious risks
Number of septicemia 1 month Estimate the effect of the strategy in terms of Infectious risks
Incidence of intra-oral hemorrhage 1 month Estimate the effect of the strategy in terms of Hemorrhagic risk
Incidence of fungal infections during hospitalization 1 month Estimate the effect of the strategy in terms of appearance of mucite
Percentage of patients receiving morphinics during hospitalization 1 month Estimate the effect of the strategy in terms of pain
Number of days with morphinic treatment 1 month Estimate the effect of the strategy in terms of pain
Percentage of patients receiving parenteral nutrition during hospitalization 1 month Estimate the effect of the strategy in terms of patient's tolerance to oral care
Number of days with parenteral nutrition 1 month Estimate the effect of the strategy in terms of patient's tolerance to oral care
Percentage of patients who had to discontinue treatment on medical advice 1 month Estimate the effect of the strategy in terms of patient's tolerance to oral care