Tolerance of Teeth Brushing During Prolonged Aplasia (NCT03879252) | Clinical Trial Compass
CompletedPhase 3
Tolerance of Teeth Brushing During Prolonged Aplasia
France76 participantsStarted 2019-07-22
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Highest score obtained at the OAG (Oral Assessment Guide) scale during the observation period