Skip to main content
OpenTrials
Completed

NCT Number: NCT03879252

Tolerance of Teeth Brushing During Prolonged Aplasia

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Aplasia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU Angers

Angers, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Toothbrush

Device

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

Mouthwashes

Drug

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

Primary outcomes

  1. Highest score obtained at the OAG (Oral Assessment Guide) scale during the observation period

    Time frame: 1 month

    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

Secondary outcomes

  1. Number of septicemia

    Time frame: 1 month

    Estimate the effect of the strategy in terms of Infectious risks

  2. Incidence of intra-oral hemorrhage

    Time frame: 1 month

    Estimate the effect of the strategy in terms of Hemorrhagic risk

  3. Number of days with intra-oral hemorrhage

    Time frame: 1 month

    Estimate the effect of the strategy in terms of Hemorrhagic risk

  4. Number of days with fever

    Time frame: 1 month

    Estimate the effect of the strategy in terms of Infectious risks

  5. Incidence of bacterial infections during hospitalization

    Time frame: 1 month

    Estimate the effect of the strategy in terms of Infectious risks

  6. Incidence of fungal infections during hospitalization

    Time frame: 1 month

    Estimate the effect of the strategy in terms of appearance of mucite

  7. Percentage of patients receiving morphinics during hospitalization

    Time frame: 1 month

    Estimate the effect of the strategy in terms of pain

  8. Number of days with morphinic treatment

    Time frame: 1 month

    Estimate the effect of the strategy in terms of pain

  9. Percentage of patients receiving parenteral nutrition during hospitalization

    Time frame: 1 month

    Estimate the effect of the strategy in terms of patient's tolerance to oral care

  10. Number of days with parenteral nutrition

    Time frame: 1 month

    Estimate the effect of the strategy in terms of patient's tolerance to oral care

  11. Percentage of patients who had to discontinue treatment on medical advice

    Time frame: 1 month

    Estimate the effect of the strategy in terms of patient's tolerance to oral care

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Official study title

Tolerance of Teeth Brushing During Prolonged Aplasia In Protected Unit

Acronym: UP-TIP

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Mar 18, 2019
Registry last updated
Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.