Diagnosis and Treatment of Periodontal Disease in Patients With AML
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About
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.
Full 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.
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Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
0 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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