Clinical trial NCT03879252: Tolerance of Teeth Brushing During Prolonged Aplasia
Official title: Tolerance of Teeth Brushing During Prolonged Aplasia In Protected Unit
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Aplasia
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2019-03-18
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Highest score obtained at the OAG (Oral Assessment Guide) scale during the observation period
timeFrame: 1 month
Secondary outcomes:
measure: Number of septicemia
timeFrame: 1 month
measure: Incidence of intra-oral hemorrhage
timeFrame: 1 month
measure: Number of days with intra-oral hemorrhage
timeFrame: 1 month
measure: Number of days with fever
timeFrame: 1 month
measure: Incidence of bacterial infections during hospitalization
timeFrame: 1 month
measure: Incidence of fungal infections during hospitalization
timeFrame: 1 month
measure: Percentage of patients receiving morphinics during hospitalization
timeFrame: 1 month
measure: Number of days with morphinic treatment
timeFrame: 1 month
measure: Percentage of patients receiving parenteral nutrition during hospitalization
timeFrame: 1 month
measure: Number of days with parenteral nutrition
timeFrame: 1 month
measure: Percentage of patients who had to discontinue treatment on medical advice
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
References: