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

Tolerance of Teeth Brushing During Prolonged Aplasia In Protected Unit

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 Overview

• Status: Completed
• Conditions: Aplasia
• Intervention / Treatment: Device: Toothbrush; Drug: Mouthwashes

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Angers, France
    • CHU Angers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: University Hospital, Angers

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2019
• Primary Completion (Actual): February 1, 2023
• Study Completion (Actual): February 1, 2023

Study Registration Dates

• First Submitted: March 14, 2019
• First Submitted That Met QC Criteria: March 15, 2019
• First Posted (Actual): March 18, 2019

Study Record Updates

• Last Update Posted (Actual): December 30, 2025
• Last Update Submitted That Met QC Criteria: December 23, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemical Actions and Uses; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Specialty Uses of Chemicals; Cosmetics; Mouthwashes
• Other Study ID Numbers: 49RC18_0147

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No