NCT04530695

Brief Summary

This is a phase 2 randomized controlled trial of pre-chemotherapy periodontal deep cleaning in Acute Myelogenous Leukemia (AML) patients with asymptomatic periodontitis. Once eligibility is confirmed, participants with periodontitis will be randomized in a 1:1 ratio to undergo treatment by scaling and root planing (SRP, "deep cleaning") (arm A) or receive no periodontal treatment (arm B). We will compare the incidence of Blood Stream Infection (BSI) during chemotherapy between the two arms. Study participation will continue until day 28 of chemotherapy or discharge from hospital, whichever occurs first.

Trial Health

45
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
6mo left

Started May 2022

Longer than P75 for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress90%
May 2022Nov 2026

First Submitted

Initial submission to the registry

August 24, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 28, 2020

Completed
1.7 years until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

February 22, 2023

Status Verified

February 1, 2023

Enrollment Period

4.5 years

First QC Date

August 24, 2020

Last Update Submit

February 20, 2023

Conditions

AMLAcute Myelogenous Leukemia

Keywords

AMLPeriodontitisBlood stream infections

Outcome Measures

Primary Outcomes (1)

  • Incidence of neutropenic fever (NF) by day 28 of chemotherapy or discharge

    Day 28 or discharge date (whichever occurs first)

Secondary Outcomes (6)

  • Incidence of BSI by day 28 of chemotherapy or discharge

    Day 28 or discharge date (whichever occurs first)

  • Incidence of blood culture-negative NF by day 28 of chemotherapy or discharge, whichever occurs first

    Day 28 or discharge date (whichever occurs first)

  • Incidence of oral mucositis by day 28 of chemotherapy or discharge, whichever occurs first

    Day 28 or discharge date (whichever occurs first)

  • Incidence of death by day 28

    Day 28 or discharge date (whichever occurs first)

  • Number of days hospitalized

    Upto 8 weeks

  • +1 more secondary outcomes

Study Arms (2)

Arm A: Deep Cleaning

EXPERIMENTAL

participants with periodontitis will undergo treatment by scaling and root planing (SRP)

Other: Scaling and Root Planing

Arm B: No cleaning

NO INTERVENTION

participants with periodontitis will undergo no periodontal treatment

Interventions

Scaling and Root PlaningOTHER

Periodontal treatment by scaling and root planing (SRP), deep cleaning

Also known as: SRP
Arm A: Deep Cleaning

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>18 years
  • Newly diagnosed or relapsed AML
  • Planned intensive chemotherapy (Any regimen expected to require 3-4 weeks of inpatient stay)
  • Antibacterial prophylaxis using levofloxacin 500 mg daily
  • Sufficient time to perform periodontal examination and treatment by day 1 of chemotherapy

You may not qualify if:

  • Prior treatment for AML, except hydroxyurea or leukapheresis
  • ANC \<0.5 x 10\^9/L at the time of enrollment
  • Post-transfusion platelet count \<50x10\^9/L at the time of enrollment
  • Unstable for transfer to the School of Dentistry
  • Fever at the time of enrollment
  • Documented infection at the time of enrollment
  • SRP in the last 3 months
  • Symptomatic periodontal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Leukemia, Myeloid, AcutePeriodontitis

Interventions

Tooth ExfoliationRoot Planing

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological PhenomenaDigestive System and Oral Physiological PhenomenaDental ScalingDental ProphylaxisPeriodonticsDentistrySubgingival CurettagePreventive Dentistry

Study Officials

  • Armin Rashidi, MD, PhD

    University of Minnesota, Division of Hematology, Oncology and Transplantation

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2020

First Posted

August 28, 2020

Study Start

May 1, 2022

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

February 22, 2023

Record last verified: 2023-02