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

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02606994

Acronym

TPvsM

Enrollment

Registered

2015-11-17

Start date

2018-05-29

Completion date

2019-02-04

Last updated

2019-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mucositis, Neoplasms

Keywords

oral mucositis, chemotherapy, toothpaste

Brief summary

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

Detailed 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.

Interventions

DRUGOral Defense Toothpaste

Brush with a Oral Defense Toothpaste three times per day during the study

DRUGCrest Toothpaste

Brush with Crest Toothpaste three times per day during the study

DRUGMagic Mouth Rinse

Participants using Crest Toothpaste who require additional pain intervention for their oral mucositis will be provided Magic Mouth Rinse

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Oral mucositis changes	Day 1 and 8 of the study	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.

Secondary

Measure	Time frame	Description
Quality of life changes	8 days	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026