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Commensal Oral Microbiota in Head and Neck Cancer

NCT03843554 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-09-26

Study results available
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Summary

The ARMOR Trial will test the efficacy of an oral care protocol to treat oral mucositis (OM) in patients receiving radiation (RT) or chemoradiation (chemoRT) for head and neck cancer. Participants will attend a screening/baseline visit, weekly intervention visits while they are undergoing RT or chemoRT, and a visit 3 months after completing RT or chemoRT. At intervention visits, samples will be collected (such as saliva, oral swabs) and participants will receive their assigned study intervention, either Oral Mucosal Deterging and Dental Prophylaxis protocol (OMDP), which includes a dental cleaning and treatment to the oral mucosa, or a Standard of Care Oral Hygiene, which includes teeth brushing and no treatment to the oral mucosa.

Conditions

Interventions

OTHER

Standard of Care Oral Hygiene

Standard of care oral hygiene- weekly oral care visits with soft-bristled toothbrushing.

PROCEDURE

Oral mucosal deterging and dental prophylaxis

Subjects will receive a professional dental prophylaxis including periodontal surface debridement \[a light-touch, gentle form of instrumentation performed with an ultrasonic instrument to promote plaque removal, to facilitate biofilm disruption and endotoxin flushing, but yet with the preservation of the periodontal cementum\] and deterging of the oral mucosal surfaces.

Sponsors & Collaborators

  • NYU Langone Health

    collaborator OTHER

  • The Forsyth Institute

    collaborator OTHER

  • Medical University of South Carolina

    collaborator OTHER

  • National Institute of Dental and Craniofacial Research (NIDCR)

    collaborator NIH

  • University of Pennsylvania

    lead OTHER

Principal Investigators

  • Patricia Corby, DDS · University of Pennsylvania

  • Alex Lin, MD · Penn Medicine, Perelman Center for Advanced Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-23
Primary Completion
2022-08-03
Completion
2022-08-03

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03843554 on ClinicalTrials.gov