NCT02606994

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Oral Defense, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mucositis
• Neoplasms

Interventions

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

Timeline

• Start date: 2018-05-29
• Primary completion: 2019-02-04
• Completion: 2019-02-04
• First posted: 2015-11-17
• Last updated: 2019-02-06

Locations

1 site across 1 country: United States