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Chemo Mouthpiece

Clinically Proven To Help Patients Reduce the Incidence and Severity of Oral Mucositis

Oral Mucositis Relief for Chemotherapy Patients

Photo of chemo patient receiving treatment with image of Chemo Mouthpiece device and icon showing 510(k) Cleared.

Available only through a health care professional, this cryotherapy device has been specially designed to cool the mouth during and after chemotherapy.

The Chemo Mouthpiece is a unique, easy-to-use oral cryotherapy device that helps minimize the occurrence and severity of chemotherapy-related oral mucositis, including discomfort, sores, ulcers and blisters in the mouth, giving adult chemotherapy patients comfort and relief from the pain and inflammation associated with mucositis.

The oral mucosa is the mucous membrane lining or “skin” inside of the mouth, including cheeks and lips. People with oral mucosal diseases may develop painful mouth sores or ulcers on this lining.

The Impact of Oral Mucositis

Photo of a close-up of a person's mouth displaying the impact of  chemotherapy-related oral mucositis.
Picture of a close-up of a mucous membrane lining inside of the mouth showing the impact of oral mucositis.

Clinical Trial Shows Chemo Mouthpiece Effectiveness

A randomized, placebo-controlled, prospective, multi-center trial to assess the efficacy of the Chemo Mouthpiece cryotherapy device versus best supportive oral care in mitigating and easing the symptoms of chemotherapy-related oral mucositis revealed the following:

Chemo Mouthpiece (CMP) Significantly Reduced Pain

In the per protocol population of the clinical trial, 23.9% of patients reported any mucosal pain in the control arm vs. 12.8% in the CMP arm (p value < .001), representing a statistically significant 46% reduction in visits where patients reported any mucosal pain.

Blue and white circular icon featuring the sentence "Chemo Mouthpiece Use Favorably Impacted Pain (Any) and Analgesic Use."
Blue and white rectangular icon representing a 68% reduction in the number of patients using opioids and other analgesics during the Chemo Mouthpiece clinical trial, showing that the Chemo Mouthpiece significantly reduced analgesic use.

CMP Significantly Reduced Analgesic Use

The CMP arm resulted in a 68% reduction in the number of patients using opioids and/or other analgesics in the per protocol analysis, representing a 3x decrease vs. patients using pain medications in the control arm.

(Data on file with Chemo Mouthpiece.),
Review trial design and information.

Thermographic imagery showing the patient before using the Chemo Mouthpiece.
Intraoral scanning has shown that after using the device, the Chemo Mouthpiece cools the gums, tongue and palate (entire oral cavity) uniformly by reducing the patient's oral temperature.

The Science Behind the Chemo Mouthpiece

The Chemo Mouthpiece uses cryotherapy to alter the body’s condition. Applying near-freezing temperatures to the mouth tissues forces the blood vessels in those tissues to shrink, reducing circulation allowing less chemotherapy drugs to reach the mouth.

When placed in a standard freezer, the inner filtered water chamber freezes solid, while the chamber filled with the saline solution will not freeze solid. The frozen inner chamber allows the circulating proprietary saline solution in the outer chamber to stay very cold, which cools the patient’s entire oral cavity.

The Chemo Mouthpiece Effectively and Uniformly Cools the Oral Cavity.

The Chemo Mouthpiece reduced patients’ oral temperature by an average of 31.2 degrees F, while ice chips only reduce it by an average of 23.2 degrees F. It also cooled the oral cavity more uniformly.
(Data on file with Chemo Mouthpiece.)

Easy To Use at Home or the Clinic

The Chemo Mouthpiece Can Provide Treatment During and After Infusion.

Patients insert the mouthpiece into their mouths, placing their lips over the outer edge. Occasionally squeeze the insulated base to circulate cold water inside the mouthpiece. The integrated breathing tubes assist with normal breathing, and the mouthpiece will press comfortably against a patient's oral cavity surfaces.

Reliable and Effective Oral Cryotherapy for the Reduction in Incidence and Severity of Oral Mucositis.

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    Cools the oral cavity uniformly
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    Tolerable for those with sensitive teeth

  • Image of checkbox used to detail the benefits of using the Chemo Mouthpiece.

    Soothes inflamed tissue and provides relief

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    Stays frozen for up to 30+ minutes

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    Single patient, multi-use
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    One size fits most adult patients
  • Portable and medication-free
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    Easily cleaned with hot water and soap

The Chemo Mouthpiece is an oral cryotherapy device consisting of four components:

HDPE plastic, medical-grade silicone, filtered water and saline solution. The Chemo Mouthpiece is a safe and effective cold therapy method used for the reduction of pain, inflammation and swelling.

Visual guide detailing the proper method for using the Chemo Mouthpiece at home or at the clinic during and after infusion.
Product illustration of the Chemo Mouthpiece, which consists of  four components: HDPE plastic, medical-grade silicone, filtered water and proprietary saline solution.

Chemo Mouthpiece Patient Testimonials

“I wanted to write you to thank you so very much for sending me the chemo mouthpieces a few months ago. I have been using them during my weekly chemo sessions and I am happy to report that I have not had ONE instance of mouth sores since using the product.

Prior to receiving the product, I suffered constantly from horrific mouth sores and was given three or four different medications to use on a daily basis, none of which worked.”

– Deborah G, metastatic breast cancer patient

“I have been using the Chemo Mouthpiece for over 3 months (3 more months to go) and have had ZERO instances of mouth sores. I am taking 5FU and get infusions every two weeks.”

– Peter J, 5FU patient

“When I tried (the Chemo Mouthpiece) for the first time, I didn’t even get one mouth sore, and I was so happy.

For anyone going through chemo and is suffering with mouth sores, I would definitely recommend Chemo Mouthpiece. It helped me so much, it changed my life, it changed my perspective on chemo because I thought I couldn’t get through with having those mouth sores.” 

– Brielle S, Hodgkin lymphoma patient and RN

Picture of a woman smiling, symbolizing that users of the Chemo Mouthpiece are happy with the results, with the caption "Read What Chemo Mouthpiece Users Are Saying."
Picture of a woman smiling, symbolizing that users of the Chemo Mouthpiece are happy with the results, with the caption "Read What Chemo Mouthpiece Users Are Saying."

The Chemo Mouthpiece Patient Kit Contains:

  • RX only

  • Six mouthpiece devices

  • Two insulated sleeves

  • Seven cold packs

  • Two cleaning brushes

  • One insulated cooler

Picture of three Chemo Mouthpieces with a visual description of the Chemo Mouthpiece patient kit that describes the kit as RX only, six mouthpiece devices, two insulated sleeves, seven cold packs, two cleaning brushes and one insulated cooler, and a badge that reads regular use of the Chemo Mouthpiece at home was associated with improved efficacy across many chemo regimens.

Chemo Mouthpiece is a trademark of ChemoMouthpiece, LLC