Tolerance of Teeth Brushing During Prolonged Aplasia (UP-TIP)

University Hospital, Angers

Status and phase: Completed; Phase 3

Conditions: Aplasia

Treatments: Drug: Mouthwashes; Device: Toothbrush

Study type: Interventional

Funder types: Other

Identifiers

NCT03879252

49RC18_0147

Details and patient eligibility

About

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.

Enrollment: 76 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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76 participants in 2 patient groups

Tooth brushing

Experimental group

Treatment:

Device: Toothbrush

Mouthwash

Active Comparator group

Treatment:

Drug: Mouthwashes