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Diagnosis and Treatment of Periodontal Disease in Patients With AML

NCT04530695 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-02-22

No results posted yet for this study

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.

Conditions

  • AML
  • Acute Myelogenous Leukemia

Interventions

OTHER

Scaling and Root Planing

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

Sponsors & Collaborators

  • Masonic Cancer Center, University of Minnesota

    lead OTHER

Principal Investigators

  • Armin Rashidi, MD, PhD · University of Minnesota, Division of Hematology, Oncology and Transplantation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-31
Primary Completion
2026-11-30
Completion
2026-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04530695 on ClinicalTrials.gov