---
title: Effect of Over-the-counter Toothpastes on Chemotherapy-induced Oral Mucositis
nct_id: NCT02606994
overall_status: TERMINATED
phase: PHASE2
sponsor: Oral Defense, LLC
study_type: INTERVENTIONAL
primary_condition: Mucositis
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02606994.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02606994"
ct_last_update_post_date: 2019-02-06
last_seen_at: "2026-05-12T06:22:12.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Effect of Over-the-counter Toothpastes on Chemotherapy-induced Oral Mucositis

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

**NCT ID:** [NCT02606994](https://clinicaltrials.gov/study/NCT02606994)

## Key Facts

- **Status:** TERMINATED
- **Why Stopped:** Lack of enrollment
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 1
- **Lead Sponsor:** Oral Defense, LLC
- **Conditions:** Mucositis, Neoplasms
- **Start Date:** 2018-05-29
- **Completion Date:** 2019-02-04
- **CT.gov Last Update:** 2019-02-06

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Oral Defense Toothpaste** (EXPERIMENTAL) — The experimental group will brush with Oral Defense Toothpaste three times per day during the study
- **Crest Toothpaste/Magic Mouth Rinse** (PLACEBO_COMPARATOR) — The placebo group will brush with Crest Toothpaste three times per day during the study. Participants in the placebo comparator group who require additional management of their oral mucositis pain will be provided Magic Mouth Rinse.

## Interventions

- **Oral Defense Toothpaste** (DRUG) — Brush with a Oral Defense Toothpaste three times per day during the study
- **Crest Toothpaste** (DRUG) — Brush with Crest Toothpaste three times per day during the study
- **Magic Mouth Rinse** (DRUG) — Participants using Crest Toothpaste who require additional pain intervention for their oral mucositis will be provided Magic Mouth Rinse

## Primary Outcomes

- **Oral mucositis changes** _(time frame: 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 Outcomes

- **Quality of life changes** _(time frame: 8 days)_

## Locations (1)

- Summit Cancer Centers, Spokane, Washington, United States

## Recent Field Changes (last 30 days)

- `design.phases` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.whyStopped` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.summit cancer centers|spokane|washington|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT02606994.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT02606994*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*