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

Oral Defense, LLC

Status and phase: Terminated; Phase 2

Conditions: Neoplasms; Mucositis

Treatments: Drug: Oral Defense Toothpaste; Drug: Magic Mouth Rinse; Drug: Crest Toothpaste

Study type: Interventional

Funder types: Industry

Identifiers

NCT02606994

OralDefenseMucositisStudy

Details and patient eligibility

About

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

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

1 participants in 2 patient groups, including a placebo group

Oral Defense Toothpaste

Experimental group

Description:

The experimental group will brush with Oral Defense Toothpaste three times per day during the study

Treatment:

Drug: Oral Defense Toothpaste

Crest Toothpaste/Magic Mouth Rinse

Placebo Comparator group

Description:

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.

Treatment:

Drug: Crest Toothpaste

Drug: Magic Mouth Rinse