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Oral mucosal deterging and dental prophylaxis for Mouth Sore (ARMOR Trial)

N/A
Waitlist Available
Led By Patricia Corby, DDS
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time from randomization to date of death from any cause, assessed assessed up to 5 years after completion of rt
Awards & highlights

ARMOR Trial Summary

This trial will test whether or not a dental cleaning and treatment to the oral mucosa helps to treat oral mucositis in patients receiving radiation or chemoradiation for head and neck cancer.

Eligible Conditions
  • Mouth Sores
  • Head and Neck Cancers

ARMOR Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from randomization to date of progression or death from any cause, whichever comes first, assessed up to 5 years after completion of rt
This trial's timeline: 3 weeks for screening, Varies for treatment, and time from randomization to date of progression or death from any cause, whichever comes first, assessed up to 5 years after completion of rt for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Oral mucosal severity
Secondary outcome measures
Pharyngeal structure
Correlative measures
Duration and time to onset of severe OM
+5 more

ARMOR Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Oral Mucosal Deterging and Dental Prophylaxis (OMDP)Experimental Treatment1 Intervention
Oral Mucosal Deterging & Dental Prophylaxis (OMDP) protocol: Subjects assigned to OMDP will attend weekly intervention visits during which they will have their teeth cleaned and will receive the OMDP intervention as follows: subjects will receive a professional dental prophylaxis including periodontal surface debridement and deterging of the oral mucosal surfaces. Subjects will be asked to follow OMDP oral hygiene instructions at home.
Group II: Standard of Care Oral HygienePlacebo Group1 Intervention
Standard of Care Oral Hygiene group (SOC-OH): Subjects assigned to SOC-OH will attend weekly oral care visits where they will have their teeth brushed with a soft bristled toothbrush by the interventionist. No treatment to the oral mucosa will be provided to this group as part of the intervention. Subjects will receive oral care instructions and will be asked to follow SOC oral hygiene instructions at home.

Find a Location

Who is running the clinical trial?

NYU Langone HealthOTHER
1,368 Previous Clinical Trials
839,666 Total Patients Enrolled
Medical University of South CarolinaOTHER
932 Previous Clinical Trials
7,394,330 Total Patients Enrolled
University of PennsylvaniaLead Sponsor
2,000 Previous Clinical Trials
42,880,028 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this investigation accessible to participants at the present time?

"This research endeavour, posted on September 23rd of 2019 and last updated April 1st 2022, is not actively recruiting participants. Nevertheless, there are 526 other clinical trials searching for volunteers at present time."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Commensal Oral Microbiota in Head and Neck Cancer
Patricia Corby, DDS 2019. "Commensal Oral Microbiota in Head and Neck Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03843554.
~11 spots leftby Apr 2025
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