Evaluation of anti-biofilm effects of Ferumoxytol using an in situ biofilm demineralization model

D
Domenick Zero, DDS, MS

Primary Investigator

Overview

The purpose of this study is to test how well a low dose of iron oxide (iron) called Ferumoxytol in combination with hydrogen peroxide helps reduce the growth of plaque on your teeth and the risk for early cavity development.

Description

The purpose of this study is to test how well a low dose of iron oxide (iron) called Ferumoxytol in combination with hydrogen peroxide helps reduce the growth of plaque on your teeth and the risk for early cavity development.

Eligibility

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    partial denture
  • Age: Between 18 Years - 85 Years
  • Gender: All

Inclusion Criteria
In good general and oral health without any known allergies to commercial dental products
Lower partial denture wearers who have a lower partial denture made for them as a part of a partial denture panel under study 14-I-098 (IRB # 1407637739) or who agree to wear their own pre-approved lower partial denture that can house both specimens on one side of their partial denture.
Exclusion Criteria
Are taking or have ever taken bisphosphonate drugs (i.e., Fosamax, Actonel and Boniva) for the treatment of osteoporosis
Use of blood thinning medications that prohibit the safe conduct of a dental cleaning
Report allergy to products (Ferumoxytol or other drugs or specific ingredients) used in the study, a reported history of multiple drug allergies or known hypersensitivity to any iron products
5Scheduled for MRI for the head region within three months after study participation involving Ferumoxytol application
Have a history of significant adverse effects following the use of oral hygiene products such as dentifrices and mouth rinses
Use of antimicrobial agents/antibiotics whether prescribed or over-the-counter within two weeks prior to each treatment visit
Presence of severe marginal gingivitis or moderate/advanced periodontitis based on the clinical examination and discretion of the dental examiner
Subjects who during the study will receive dental treatment, which may affect their participation (i.e. oral prophylaxis). Emergency treatment will be allowed if necessary
Those requiring antibiotic premedication prior to dental treatment
Participation in a dental clinical trial involving oral care products within 30 days of randomization (Baseline Visit)
Self-reported pregnancy or lactation or intent to become pregnant during the study period
Self-reported chewing tobacco user
Significant unstable or uncontrolled medical condition, which may interfere with a subject's participation in the study

Updated on 20 Nov 2022. Study ID: 1802077294

Interested in the study?

Select a study center that’s convenient for you, and get in touch with the study team.

Contact a study center