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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02606994
Other study ID # OralDefenseMucositisStudy
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date May 29, 2018
Est. completion date February 4, 2019

Study information

Verified date February 2019
Source Oral Defense, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether Oral Defense Toothpaste causes accelerated healing of chemotherapy-induced oral mucositis.


Description:

A pilot study showed that patients with chemotherapy-induced oral mucositis experienced accelerated healing of their oral mucositis by brushing with Oral Defense Toothpaste.

In this study, participants experiencing up to grade 2 chemotherapy-induced oral mucositis will be split into two arms. The first arm (test arm) will receive Oral Defense Toothpaste and be required to brush three times per day, for 8 days. The second arm (control arm) will receive Crest Toothpaste and be required to brush three times per day, for 8 days. Patients in the control arm will be provided Magic Mouth Rinse, if needed. Healing of oral mucositis lesions will be evaluated at days 1 and 8. Quality of life assessment (determination of pain/loss of oral function) will be determined using a daily questionnaire.


Recruitment information / eligibility

Status Terminated
Enrollment 1
Est. completion date February 4, 2019
Est. primary completion date February 4, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients over the age of 18 receiving chemotherapy

- Mucositis lesions not exceeding grade 2

Exclusion Criteria:

- Patients receiving high load chemotherapy

- Patients receiving radiation therapy

- Patients receiving oral antivirals, oral antifungals or oral antibacterials

- Patients experiencing oral candidiasis

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Oral Defense Toothpaste
Brush with a Oral Defense Toothpaste three times per day during the study
Crest Toothpaste
Brush with Crest Toothpaste three times per day during the study
Magic Mouth Rinse
Participants using Crest Toothpaste who require additional pain intervention for their oral mucositis will be provided Magic Mouth Rinse

Locations

Country Name City State
United States Summit Cancer Centers Spokane Washington

Sponsors (1)

Lead Sponsor Collaborator
Oral Defense, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Oral mucositis changes The primary measure is the healing of chemotherapy induced oral mucositis lesions which are evaluated at days 1 and 8 of the study. The clinical investigators will identify patients who qualify for the study and this will mark day 1 of the study. At days 1 and 8 of the study, the clinical investigators will evaluate the oral cavity of each study participant and document changes in the oral mucositis of the participants. Day 1 and 8 of the study
Secondary Quality of life changes Each participant will fill out a quality of life questionnaire every day of the study. An evaluated outcome is when their chemotherapy induced oral mucositis lesions have resolved and their quality of life has returned to pre-chemotherapy levels. 8 days
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