Tolerance of Teeth Brushing During Prolonged Aplasia

Aplasia Clinical Trial

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Official title:

Tolerance of Teeth Brushing During Prolonged Aplasia In Protected Unit

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03879252
• Other study ID #: 49RC18_0147
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: June 2019
• Est. completion date: January 2022

Study information

• Verified date: March 2019
• Source: University Hospital, Angers
• Contact: Amandine Valette
• Phone: 0241353637
• Email: Amandine.Valette[@]chu-angers.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: January 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aplasia

Intervention

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

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 month
Secondary	Number of septicemia	Estimate the effect of the strategy in terms of Infectious risks	1 month
Secondary	Incidence of intra-oral hemorrhage	Estimate the effect of the strategy in terms of Hemorrhagic risk	1 month
Secondary	Number of days with intra-oral hemorrhage	Estimate the effect of the strategy in terms of Hemorrhagic risk	1 month
Secondary	Number of days with fever	Estimate the effect of the strategy in terms of Infectious risks	1 month
Secondary	Incidence of bacterial infections during hospitalization	Estimate the effect of the strategy in terms of Infectious risks	1 month
Secondary	Incidence of fungal infections during hospitalization	Estimate the effect of the strategy in terms of appearance of mucite	1 month
Secondary	Percentage of patients receiving morphinics during hospitalization	Estimate the effect of the strategy in terms of pain	1 month
Secondary	Number of days with morphinic treatment	Estimate the effect of the strategy in terms of pain	1 month
Secondary	Percentage of patients receiving parenteral nutrition during hospitalization	Estimate the effect of the strategy in terms of patient's tolerance to oral care	1 month
Secondary	Number of days with parenteral nutrition	Estimate the effect of the strategy in terms of patient's tolerance to oral care	1 month
Secondary	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	1 month