Tolerance of Teeth Brushing During Prolonged Aplasia | NCT03879252

Studies
Tolerance of Teeth Brushing During Prolonged Aplasia

NCT03879252

Sponsor

University Hospital, Angers

Status

Completed

Last Update Posted

Dec 30, 2025Actual

Enrollment

76Actual

Phase

Phase 3

Conditions

Aplasia

Interventions

Toothbrush
Mouthwashes

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 22, 2019Actual

Primary Completion Date

Feb 1, 2023Actual

Completion Date

Feb 1, 2023Actual

First Submitted Date

Mar 14, 2019

First Submission Date that Met QC Criteria

Mar 15, 2019

First Posted Date

Mar 18, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 23, 2025

Last Update Posted Date

Dec 30, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

76Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tooth brushing	Experimental		Device: Toothbrush
Mouthwash	Active Comparator		Drug: Mouthwashes

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Toothbrush	Device	Brushing teeth three times a day (extra-soft toothbrush) with a 1.4% baking mouthwash solution.	Tooth brushing

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
Number of septicemia	Estimate the effect of the strategy in terms of Infectious risks	1 month
Incidence of intra-oral hemorrhage	Estimate the effect of the strategy in terms of Hemorrhagic risk

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009067	Mouthwashes

Ancestor Terms

ID	Term
D001697	Biomedical and Dental Materials
D020313	Specialty Uses of Chemicals
D020164	Chemical Actions and Uses
D003358	Cosmetics

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Browse Branches

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