AplasiaPhase 3UP-TIPNCT03879252
Tolerance of Teeth Brushing During Prolonged Aplasia
A Phase 3 study testing Toothbrush and Mouthwashes in people with Aplasia, run by University Hospital, Angers at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aplasia
- What is being tested?
- Toothbrush and Mouthwashes
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteFrance
- Study dates
- 22 Jul 2019to 1 Feb 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Aplasia
- Being tested
- Toothbrush, Mouthwashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ToothbrushDevice
Brushing teeth three times a day (extra-soft toothbrush) with a 1.4% baking mouthwash solution.
MouthwashesDrug
Mouthwashes three times a day with a 1.4% baking mouthwash solution.
| Study group | Role | What they receive |
|---|---|---|
| Tooth brushing | Experimental | Not described Receives: Device: Toothbrush |
| Mouthwash | Active comparator | Not described Receives: Drug: Mouthwashes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 month
Secondary outcomes (11)
Number of septicemia
Estimate the effect of the strategy in terms of Infectious risks
Measured: 1 month
Incidence of intra-oral hemorrhage
Estimate the effect of the strategy in terms of Hemorrhagic risk
Measured: 1 month
Number of days with intra-oral hemorrhage
Estimate the effect of the strategy in terms of Hemorrhagic risk
Measured: 1 month
Number of days with fever
Estimate the effect of the strategy in terms of Infectious risks
Measured: 1 month
Incidence of bacterial infections during hospitalization
Estimate the effect of the strategy in terms of Infectious risks
Measured: 1 month
Incidence of fungal infections during hospitalization
Estimate the effect of the strategy in terms of appearance of mucite
Measured: 1 month
Percentage of patients receiving morphinics during hospitalization
Estimate the effect of the strategy in terms of pain
Measured: 1 month
Number of days with morphinic treatment
Estimate the effect of the strategy in terms of pain
Measured: 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
Measured: 1 month
Number of days with parenteral nutrition
Estimate the effect of the strategy in terms of patient's tolerance to oral care
Measured: 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
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2019
- Study start22 Jul 2019
- Primary completion1 Feb 2023
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AplasiaStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03879252
- Sponsor's protocol ID
- 49RC18_0147
- Acronym
- UP-TIP
- Status last verified
- Dec 2025
- First submitted
- 14 Mar 2019
- Last updated
- 30 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerance of Teeth Brushing During Prolonged Aplasia In Protected Unit
- ClinicalTrials.gov ID
- NCT03879252
- Acronym / sponsor ID
- UP-TIP / 49RC18_0147
- Conditions
- Aplasia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 22 Jul 2019 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 18 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tooth brushing | Experimental | Device: Toothbrush |
| Mouthwash | Active comparator | Drug: Mouthwashes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ToothbrushBrushing teeth three times a day (extra-soft toothbrush) with a 1.4% baking mouthwash solution. | Device | Tooth brushing |
| MouthwashesMouthwashes three times a day with a 1.4% baking mouthwash solution. | Drug | Mouthwash |
Primary outcome
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
11 secondary outcomes
Number of septicemia
Time frame: 1 month
Incidence of intra-oral hemorrhage
Time frame: 1 month
Number of days with intra-oral hemorrhage
Time frame: 1 month
Number of days with fever
Time frame: 1 month
Incidence of bacterial infections during hospitalization
Time frame: 1 month
Incidence of fungal infections during hospitalization
Time frame: 1 month
Percentage of patients receiving morphinics during hospitalization
Time frame: 1 month
Number of days with morphinic treatment
Time frame: 1 month
Percentage of patients receiving parenteral nutrition during hospitalization
Time frame: 1 month
Number of days with parenteral nutrition
Time frame: 1 month
Percentage of patients who had to discontinue treatment on medical advice
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Toothbrush and Mouthwashes in people with Aplasia, run by University Hospital, Angers at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Highest score obtained at the OAG (Oral Assessment Guide) scale during the observation period (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.