Tolerance of Teeth Brushing During Prolonged Aplasia In Protected Unit
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 76
- Locations
- 1
- Primary Endpoint
- Highest score obtained at the OAG (Oral Assessment Guide) scale during the observation period
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Tooth brushing
Intervention: Toothbrush (Device)
Mouthwash
Intervention: Mouthwashes (Drug)
Outcomes
Primary Outcomes
Highest score obtained at the OAG (Oral Assessment Guide) scale during the observation period
Time Frame: 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 Outcomes
- Number of days with intra-oral hemorrhage(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)
- 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)