Trial | NCT02606994  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    1
The purpose of this study is to determine whether Oral Defense Toothpaste causes accelerated healing of chemotherapy-induced oral mucositis.
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.
Study Started
May 29
2018
Primary Completion
Feb 04
2019
Study Completion
Feb 04
2019
Last Update
Feb 06
2019

Drug Oral Defense Toothpaste

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

  • Other names: Experimental toothpaste

Drug Crest Toothpaste

Brush with Crest Toothpaste three times per day during the study

  • Other names: Control Toothpaste

Drug Magic Mouth Rinse

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

  • Other names: Viscous Lidocaine 2%, Maalox, Diphenhydramine 12.5mg/5ml

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.

Criteria 

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
No Results Posted