MIPS Project Detail:

MastiX LLC

Treating Gingivitis with a Functional Chewing Gum

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Company

MastiX LLC

Hunt Valley

Baltimore

County

, Maryland

Founded:

2016

Website:

http://mastixmedica.com/

Company Description:

Mastix LLC develops and manufactures niche healthcare products such as tableted chewing gum, chewable tablets and lozenges. Mastix is one of only a few companies in the world (and the only one in the U.S.) that has the ability to make tableted chewing gum products at room temperature versus the traditional high-heat process, which degrades active ingredients and reduces their efficacy. Mastix can also create custom formulations.

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MIPS Project

Treating Gingivitis with a Functional Chewing Gum

Project #

5925

|

MIPS Round

59 |

Starting Date:

Feb 2017

MIPS Project Challenge:
The goal of this MIPS project is to determine whether the use of a Blackberry Extract and Chitosan Chewing Gum (BEC Gum) will aid in the reduction of gingival inflammation and dental plaque.

Project Scope:
For this MIPS project, researchers planned a prospective, randomized, three-month, double-blinded, single-center study, through which patients with mild to moderate gingivitis will be identified and enrolled in the investigation. All enrolled subjects will receive baseline oral hygiene brushing instructions and a baseline clinical examination of the gingiva. The test group will utilize BEC Gum three times a day for a minimum of 20-30 minutes duration of the study, while the control group will receive a placebo gum and use it in a similar manner.

MIPS helped my company fund a clinical study for a firstof-its-kind product that will provide relief to millions of consumers seeking a convenient and easy-to-use solution to the common and wide-spread dental problem of gingivitis.

Robert Estey, CEO, Mastix LLC

Results:

This study could provide the data for the FDA to evaluate the regulatory path for BEC Gum to make an application as a medical device, which would make it the first of its kind, and provide a strong label for better commercialization. Gingivitis and periodontal disease affects about 50 percent of adults over the age of 30, according to the 2009–2010 National Health and Nutrition Examination Survey. (Source: MastiX LLC)