Effect of Over-the-counter Toothpastes on Chemotherapy-induced Oral Mucositis

Neoplasms Clinical Trial

— TPvsM  

Official title:

Comparison of the Healing of Chemotherapy-Induced Oral Mucositis Using Oral Defense Toothpaste Versus Crest Toothpaste and Magic Mouth Rinse

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02606994
• Other study ID #: OralDefenseMucositisStudy
• Status: Terminated
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Mucositis
• Neoplasms
• Stomatitis

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