Diagnosis and Treatment of Periodontal Disease in Patients With AML

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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AML, Acute Myelogenous Leukemia

Intervention / Treatment
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* Other: Scaling and Root Planing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A: Deep Cleaning<br>participants with periodontitis will undergo treatment by scaling and root planing (SRP) | Other: Scaling and Root Planing<br>* Periodontal treatment by scaling and root planing (SRP), deep cleaning<br>* Other names: SRP;|
| No Intervention: Arm B: No cleaning<br>participants with periodontitis will undergo no periodontal treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of neutropenic fever (NF) by day 28 of chemotherapy or discharge |  | Day 28 or discharge date (whichever occurs first) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of BSI by day 28 of chemotherapy or discharge | Incidence of bloodstream infections by day 28 of chemotherapy or discharge (whichever occurs first). | 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 | Hospitalization length | Upto 8 weeks | 
| Incidence of Neutropenic Fever within 2 days after periodontal examination/treatment (safety endpoint) |  | within 2 days after periodontal examination/treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AML, Periodontitis, Blood stream infections