UP-TIP: Tolerance of Teeth Brushing During Prolonged Aplasia

Sponsor

University Hospital, Angers (Other)

Overall Status

Unknown status

CT.gov ID

NCT03879252

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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

Study Type:

Interventional

Anticipated 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

Anticipated Study Start Date :

Jun 1, 2019

Anticipated Primary Completion Date :

Jan 1, 2022

Anticipated Study Completion Date :

Jan 1, 2022

Arms and Interventions

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.

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

Primary Outcome Measures

Highest score obtained at the OAG (Oral Assessment Guide) scale during the observation period [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

Number of septicemia [1 month]
Estimate the effect of the strategy in terms of Infectious risks
Incidence of intra-oral hemorrhage [1 month]
Estimate the effect of the strategy in terms of Hemorrhagic risk
Number of days with intra-oral hemorrhage [1 month]
Estimate the effect of the strategy in terms of Hemorrhagic risk
Number of days with fever [1 month]
Estimate the effect of the strategy in terms of Infectious risks
Incidence of bacterial infections during hospitalization [1 month]
Estimate the effect of the strategy in terms of Infectious risks
Incidence of fungal infections during hospitalization [1 month]
Estimate the effect of the strategy in terms of appearance of mucite
Percentage of patients receiving morphinics during hospitalization [1 month]
Estimate the effect of the strategy in terms of pain
Number of days with morphinic treatment [1 month]
Estimate the effect of the strategy in terms of pain
Percentage of patients receiving parenteral nutrition during hospitalization [1 month]
Estimate the effect of the strategy in terms of patient's tolerance to oral care
Number of days with parenteral nutrition [1 month]
Estimate the effect of the strategy in terms of patient's tolerance to oral care
Percentage of patients who had to discontinue treatment on medical advice [1 month]
Estimate the effect of the strategy in terms of patient's tolerance to oral care

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

No locations specified.

Sponsors and Collaborators

University Hospital, Angers

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Angers

ClinicalTrials.gov Identifier:

NCT03879252

Other Study ID Numbers:

49RC18_0147

First Posted:

Mar 18, 2019

Last Update Posted:

Mar 18, 2019

Last Verified:

Mar 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Mar 18, 2019