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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Periodontal treatment by scaling and root planing (SRP), deep cleaning
Incidence of neutropenic fever (NF) by day 28 of chemotherapy or discharge
Time frame: Day 28 or discharge date (whichever occurs first)
Incidence of BSI by day 28 of chemotherapy or discharge
Incidence of bloodstream infections by day 28 of chemotherapy or discharge (whichever occurs first).
Time frame: Day 28 or discharge date (whichever occurs first)
Incidence of blood culture-negative NF by day 28 of chemotherapy or discharge, whichever occurs first
Time frame: Day 28 or discharge date (whichever occurs first)
Incidence of oral mucositis by day 28 of chemotherapy or discharge, whichever occurs first
Time frame: Day 28 or discharge date (whichever occurs first)
Incidence of death by day 28
Time frame: Day 28 or discharge date (whichever occurs first)
Number of days hospitalized
Hospitalization length
Time frame: Upto 8 weeks
Incidence of Neutropenic Fever within 2 days after periodontal examination/treatment (safety endpoint)
Time frame: within 2 days after periodontal examination/treatment
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