Diagnosis and Treatment of Periodontal Disease in Patient... | NCT04530695

Studies
Diagnosis and Treatment of Periodontal Disease in Patients With AML

NCT04530695

Sponsor

Masonic Cancer Center, University of Minnesota

Status

Withdrawn

Last Update Posted

Feb 22, 2023Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

AML
Acute Myelogenous Leukemia

Interventions

Scaling and Root Planing

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

PI left institution and research was cancelled due to his departure

Expanded Access Info

Start Date

May 2022Estimated

Primary Completion Date

Nov 2026Estimated

Completion Date

Nov 2026Estimated

First Submitted Date

Aug 24, 2020

First Submission Date that Met QC Criteria

Aug 27, 2020

First Posted Date

Aug 28, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 20, 2023

Last Update Posted Date

Feb 22, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm A: Deep Cleaning	Experimental	participants with periodontitis will undergo treatment by scaling and root planing (SRP)	Other: Scaling and Root Planing
Arm B: No cleaning	No Intervention	participants with periodontitis will undergo no periodontal treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Scaling and Root Planing	Other	Periodontal treatment by scaling and root planing (SRP), deep cleaning	Arm A: Deep Cleaning

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Armin Rashidi, MD, PhD	University of Minnesota, Division of Hematology, Oncology and Transplantation	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015470	Leukemia, Myeloid, Acute
D010518	Periodontitis

Ancestor Terms

ID	Term
D007951	Leukemia, Myeloid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014080	Tooth Exfoliation
D016745	Root Planing

Ancestor Terms

ID	Term
D009063	Dental Physiological Phenomena
D055688	Digestive System and Oral Physiological Phenomena
D012534	Dental Scaling
D003777	Dental Prophylaxis

Browse Leaves

Not provided

Browse Branches

Not provided