Tolerance of Teeth Brushing During Prolonged Aplasia

NCT03879252 | Completed Phase 3

• 1 other identifier: 49RC18_0147
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Aplasia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Number of septicemia

  1 month

• Incidence of intra-oral hemorrhage

  1 month

• Number of days with intra-oral hemorrhage

  1 month

• Number of days with fever

  1 month

• Incidence of bacterial infections during hospitalization

  1 month

Study Arms (2)

Tooth brushing

EXPERIMENTAL

Device: Toothbrush

Mouthwash

ACTIVE COMPARATOR

Drug: Mouthwashes

Interventions

Toothbrush DEVICE

Brushing teeth three times a day (extra-soft toothbrush) with a 1.4% baking mouthwash solution.

Tooth brushing

Mouthwashes DRUG

Mouthwashes three times a day with a 1.4% baking mouthwash solution.

Mouthwash

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

CHU Angers

Angers, France

Location

MeSH Terms

Interventions

Mouthwashes

Intervention Hierarchy (Ancestors)

Biomedical and Dental Materials; Specialty Uses of Chemicals; Chemical Actions and Uses; Cosmetics; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2019
• First Posted: March 18, 2019
• Study Start: July 22, 2019
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)