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Oral Care Protocol for the Management of Chemotherapy and Radiation Therapy-Induced Oral Mucositis

NCT02608879 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2020-08-28

Study results available
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Summary

The purpose of this study is to determine the effects of a novel oral care protocol on the severity and pain of oral mucositis in patients receiving radiation and/or chemotherapy for head and neck cancers. The secondary objectives are to characterize the microbiome associated with oral mucositis, measure salivary proinflammatory cytokines, and evaluate other clinical indicators of the intervention. Participants will be enrolled prior to beginning radiation and/or chemotherapy, and will be randomized to receive either the oral health protocol or standard of care oral hygiene.

Conditions

  • Oral Mucositis
  • Oral Cancer

Interventions

PROCEDURE

Oral Mucosa Deterging and Periodontal Debridement (OMDP)

OMDP consists of a regimen of frequent professional oral prophylaxis including tooth cleaning, tooth polishing and flossing, and the cleaning of the periodontum and oral mucosa. This is an intervention that is implemented prior to and maintained throughout the entire cycle of the radiation or chemoradiation.

PROCEDURE

Standard of Care Oral Hygiene Instructions

Subjects assigned to this intervention will receive standard of care oral hygiene instructions, including in-person instruction and materials to reference at home. Subjects will also have their teeth brushed and flossed bi-weekly by a dental professional.

PROCEDURE

Dental scaling, ultrasonic

An ultrasonic dental scaler will be used to clean the teeth

OTHER

Chlorhexidine

Non-alcoholic chlorhexidine will be used as part of the OMDP protocol

Sponsors & Collaborators

Principal Investigators

  • Patricia Corby, DDS, MS · NYU Langone Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2015-09-30
Completion
2015-09-30

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT02608879 on ClinicalTrials.gov