A Phase 3 interventional study of Toothbrush and Mouthwashes in Aplasia, sponsored by University Hospital, Angers. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-30.
Sponsored by University Hospital, Angers · Phase 3, Interventional, and Treatment
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.
University Hospital, Angers is the lead sponsor of 464 studies on the registry; 116 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: Toothbrush
Drug: Mouthwashes
Brushing teeth three times a day (extra-soft toothbrush) with a 1.4% baking mouthwash solution.
Mouthwashes three times a day with a 1.4% baking mouthwash solution.
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
Time frame: 1 month
Number of septicemia
Estimate the effect of the strategy in terms of Infectious risks
Time frame: 1 month
Incidence of intra-oral hemorrhage
Estimate the effect of the strategy in terms of Hemorrhagic risk
Time frame: 1 month
Number of days with intra-oral hemorrhage
Estimate the effect of the strategy in terms of Hemorrhagic risk
Time frame: 1 month
Number of days with fever
Estimate the effect of the strategy in terms of Infectious risks
Time frame: 1 month
Incidence of bacterial infections during hospitalization
Estimate the effect of the strategy in terms of Infectious risks
Time frame: 1 month
Incidence of fungal infections during hospitalization
Estimate the effect of the strategy in terms of appearance of mucite
Time frame: 1 month
Percentage of patients receiving morphinics during hospitalization
Estimate the effect of the strategy in terms of pain
Time frame: 1 month
Number of days with morphinic treatment
Estimate the effect of the strategy in terms of pain
Time frame: 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
Time frame: 1 month
Number of days with parenteral nutrition
Estimate the effect of the strategy in terms of patient's tolerance to oral care
Time frame: 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
Time frame: 1 month
Plan to share: No
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This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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University Hospital, Angers