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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03879252
Recruitment Status : Unknown
Verified March 2019 by University Hospital, Angers.
Recruitment status was:  Not yet recruiting
First Posted : March 18, 2019
Last Update Posted : March 18, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers

Study Description
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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.


Condition or disease Intervention/treatment Phase
Aplasia Device: Toothbrush Drug: Mouthwashes Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tolerance of Teeth Brushing During Prolonged Aplasia In Protected Unit
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03879252


Contacts
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Contact: Amandine Valette 0241353637 ext +33 Amandine.Valette@chu-angers.fr
Contact: Béatrice GABLE 0241356825 ext +33 begable@chu-angers.fr

Sponsors and Collaborators
University Hospital, Angers
More Information
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Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT03879252    
Other Study ID Numbers: 49RC18_0147
First Posted: March 18, 2019    Key Record Dates
Last Update Posted: March 18, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No