Diagnosis and Treatment of Periodontal Disease in Patients With AML

NCT ID: NCT04530695

Last Updated: 2023-02-22

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-31
• Study Completion Date: 2026-11-30

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.

Detailed 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.

Conditions

AML; Acute Myelogenous Leukemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A: Deep Cleaning

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

Group Type: EXPERIMENTAL

Scaling and Root Planing

Intervention Type: OTHER

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

Arm B: No cleaning

participants with periodontitis will undergo no periodontal treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Scaling and Root Planing

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

Intervention Type: OTHER

Other Intervention Names

SRP

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Masonic Cancer Center, University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Armin Rashidi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota, Division of Hematology, Oncology and Transplantation

Other Identifiers

2020LS118

Identifier Type: -

Identifier Source: org_study_id