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

O

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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