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Diagnosis and Treatment of Periodontal Disease in Patients With AML

Acute Myelogenous Leukemia Clinical Trial

Official title:
Early Diagnosis and Treatment of Periodontal Disease in Patients With AML to Reduce Bloodstream Infections During Chemotherapy

Clinical Trial 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.

Clinical Trial Description

Bloodstream infection (BSI) is common in patients with acute myeloid leukemia (AML) and causes significant morbidity and mortality. Chemotherapy disrupts oral and intestinal mucosal barriers, facilitating bacterial translocation to the bloodstream. Baseline periodontitis is associated with higher risk of BSI during chemotherapy. In AML patients, since baseline screening and treatment of asymptomatic periodontitis is currently not a standard practice, the researchers are hoping to (i) personalize supportive care according to patient-specific risk factors; (ii) promote an interdisciplinary approach to supportive care by bringing periodontists into the treatment team; (iii) improve quality of life by reducing hospitalization length; (iv) decrease the incidence of re-hospitalization during future phases of treatment; (v) decrease early treatment related mortality (TRM); and (vi) decrease healthcare costs. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04530695
Study type Interventional
Source Masonic Cancer Center, University of Minnesota
Contact
Status Withdrawn
Phase N/A
Start date May 2022
Completion date November 2026
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