Clinical trial · Interventional
Diagnosis and Treatment of Periodontal Disease in Patients With AML
Early Diagnosis and Treatment of Periodontal Disease in Patients With AML to Reduce Bloodstream Infections During Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): PI left institution and research was cancelled due to his departure
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myelogenous Leukemia | Acute Myeloid Leukemia | ALIAS | 0.90 |
| AML | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Scaling and Root Planing | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A: Deep Cleaning
- description
- participants with periodontitis will undergo treatment by scaling and root planing (SRP)
- interventionNames
- Other: Scaling and Root Planing
- type
- NO_INTERVENTION
- label
- Arm B: No cleaning
- description
- participants with periodontitis will undergo no periodontal treatment
Primary outcomes (1)
- measure
- Incidence of neutropenic fever (NF) by day 28 of chemotherapy or discharge
- timeFrame
- Day 28 or discharge date (whichever occurs first)
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available