Tolerance of Teeth Brushing During Prolonged Aplasia

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.

Official Title
-----------------
Tolerance of Teeth Brushing During Prolonged Aplasia In Protected Unit

Conditions
-----------------
Aplasia

Intervention / Treatment
-----------------
* Device: Toothbrush
* Drug: Mouthwashes


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tooth brushing<br> | Device: Toothbrush<br>* Brushing teeth three times a day (extra-soft toothbrush) with a 1.4% baking mouthwash solution.<br>|
| Active Comparator: Mouthwash<br> | Drug: Mouthwashes<br>* Mouthwashes three times a day with a 1.4% baking mouthwash solution.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Highest score obtained at the OAG (Oral Assessment Guide) scale during the observation period | 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 | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of septicemia | Estimate the effect of the strategy in terms of Infectious risks | 1 month | 
| Incidence of intra-oral hemorrhage | Estimate the effect of the strategy in terms of Hemorrhagic risk | 1 month | 
| Number of days with intra-oral hemorrhage | Estimate the effect of the strategy in terms of Hemorrhagic risk | 1 month | 
| Number of days with fever | Estimate the effect of the strategy in terms of Infectious risks | 1 month | 
| Incidence of bacterial infections during hospitalization | Estimate the effect of the strategy in terms of Infectious risks | 1 month | 
| Incidence of fungal infections during hospitalization | Estimate the effect of the strategy in terms of appearance of mucite | 1 month | 
| Percentage of patients receiving morphinics during hospitalization | Estimate the effect of the strategy in terms of pain | 1 month | 
| Number of days with morphinic treatment | Estimate the effect of the strategy in terms of pain | 1 month | 
| Percentage of patients receiving parenteral nutrition during hospitalization | Estimate the effect of the strategy in terms of patient's tolerance to oral care | 1 month | 
| Number of days with parenteral nutrition | Estimate the effect of the strategy in terms of patient's tolerance to oral care | 1 month | 
| Percentage of patients who had to discontinue treatment on medical advice | Estimate the effect of the strategy in terms of patient's tolerance to oral care | 1 month |