Dental CariesEarly Phase 1NCT03678012

Evaluation of Anti-biofilm Effects of Ferumoxytol (Feraheme) Using an in Situ Biofilm Demineralization Model

A Early Phase 1 study testing Ferumoxytol/Hydrogen peroxide, Hydrogen Peroxide and Water in people with Dental Caries, run by University of Pennsylvania at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To evaluate the effects of a clinically approved and commercially available iron oxide formulation Ferumoxytol (Feraheme®) to control cariogenic biofilms and enamel demineralization. This study will be testing topical application of Ferumoxytol extra-orally using a standard in situ biofilm demineralization model. Read more about this study

Who is it for?: Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for: Dental Caries
What is being tested?: Ferumoxytol/Hydrogen peroxide, Hydrogen Peroxide and Water
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 16 participants
Where: 2 sitesUnited States
Study dates: 7 Jun 2018to 16 Aug 2018
Phase: Early Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Males and females 18 to 85 years of age and in good general and oral health without any known allergies to commercial dental products;
Evidence of a personally signed and dated informed consent document indicating the subject has been informed of all pertinent aspects of the trial;
Willingness to use the assigned products according to instructions, availability for appointments and likelihood of completing the clinical trial;
Willing to adhere to the study requirements and restrictions;
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.

Who cannot join

Oral Examination Inclusion Criteria:
Normal salivary flow rate (stimulated and unstimulated flow of ≥ 0.8 mL/min and ≥ 0.2 mL/min, respectively) ascertained from the Screening visit;
Willing and capable of wearing the lower partial denture 24 hours a day for the three, two-week treatment periods. Note: for persons who would otherwise qualify but whose lower partial denture needs repair, the individual may be listed as "pending". Once the partial denture has been repaired and adjusted to fit adequately for the subject to wear the lower partial denture 24 hours a day, the subject may be considered "qualified", complete their minimum 4 to 5 days washout period (of their own fluoridated toothpaste use) and continue with visit 2 in the study;
Absence of significant oral soft tissue pathology and dental caries, based on the dentist's visual examination and at the discretion of the investigator. Note: for persons who would otherwise qualify but who present at screening with dental caries requiring treatment, the individual may be listed as "pending". If the subject completes the restorative work within an acceptable amount of time, the subject may be considered qualified, complete their minimum 4 to 5 day washout period (of their own fluoridated toothpaste use) and continue with visit 2 in the study; and
Adequate oral hygiene (i.e. brush teeth daily and exhibit no signs of oral neglect).
Exclusion Criteria: Subjects presenting with any of the following will not be included in the trial:

Show all 24Show fewer

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 (*NOTE: Subjects who are taking blood thinners in which written verification is obtained from their physician indicating their PT/INR levels (anti-coagulation blood levels) are at an acceptable level to avoid serious complications, such as bleeding during dental cleanings, may be accepted into the study);
Suspected alcohol or substance abuse (e.g., amphetamines, benzodiazepines, cocaine, marijuana, opiates) in the past year;
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;
Scheduled 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;
Subjects who were previously screened and ineligible or were randomized to receive investigational product;
Significant unstable or uncontrolled medical condition, which may interfere with a subject's participation in the study;
Subjects who are related to those persons involved directly or indirectly with the conduct of this study; and
Other severe, acute or chronic, medical or psychiatric condition(s) or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
If the subject reports taking medication, a history of allergy, and/or a chronic disease which in the opinion of the investigator will not affect the clinical parameter(s) being assessed in this study or the safety of the subject, the subject may be enrolled in the study and it will be noted on the Investigator's source document.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Oral Health Research Institute
Indianapolis, Indiana, 46202
University of Pennsylvania, School of dental medicine
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Read the detailed description

This will be a randomized, crossover, single blind in situ study with three test periods utilizing 16 subjects. The subjects in this study are lower partial denture wearers who have already had a study partial denture made for them as a part of a partial denture panel under 14-I-098 (IRB # 1407637739) or who will wear their own lower partial denture which was previously approved as part of the panel. The study partial dentures or personal partial dentures can house the specimen holders in two hollowed out areas of the buccal surface of two posterior denture teeth. The subjects will wear the lower partial dentures with enamel specimens in place for three consecutive 14-day study periods.

Conditions: Dental Caries
Being tested: Ferumoxytol/Hydrogen peroxide, Hydrogen Peroxide, Water
Medical subject headings: Dental Caries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ferumoxytol/Hydrogen peroxideDrug
Also called Feraheme
1.5% Ferumoxytol / 3% Hydrogen Peroxide (H2O2) 1:1 ratio. Each subject will use this product during one of three treatment periods in the crossover study design.
Hydrogen PeroxideDrug
Sham Solution / 3% Hydrogen Peroxide (H2O2) 1:1 ratio. Each subject will use this product during one of three treatment periods in the crossover study design.
WaterDrug
Sham solution (water; negative control). Each subject will use this product during one of three treatment periods in the crossover study design.

Study groups in NCT03678012
Study group	Role	What they receive
Ferumoxytol/Hydrogen peroxide	Active comparator	1.5% Ferumoxytol / 3% Hydrogen Peroxide (H2O2) 1:1 ratio Receives: Drug: Ferumoxytol/Hydrogen peroxide
Hydrogen peroxide	Placebo comparator	Sham Solution / 3% Hydrogen Peroxide (H2O2) 1:1 ratio Receives: Drug: Hydrogen Peroxide
Water	Sham comparator	Sham solution (water; negative control) Receives: Drug: Water

What is being measured

The primary outcome is the main question the study is designed to answer.

Biofilm Analyses-cell viability
The effect of the treatments will be analyzed in terms of biochemical and microbiological composition of the biofilm formed. Colony forming unit (CFU) will be used to quantify the number of viable cells in biofilms.
Measured: 14 days
Biofilm Analysis-extracellular polysaccharides
Biofilm EPS amount (weight in milligram) will be determined using colorimetric assay.
Measured: 14 days

Secondary outcomes (1)

Assessment of Enamel Demineralization by Means of Surface Microhardness Test (SMH)
The surface microhardness (SMH, length in micrometer) test will be used to assess changes in the mineral status of enamel specimens.
Measured: 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Jun 201816 Aug 2018

First posted19 Sep 2018
Study start7 Jun 2018
Primary completion16 Aug 2018
Study completion16 Aug 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Dental CariesStudies of the same condition, open and under way.
More trials run by University of PennsylvaniaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Early Phase 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Model description: This will be a randomized, crossover, single blind in situ study with three test periods utilizing 16 subjects. The subjects in this study are lower partial denture wearers who have already had a study partial denture made for them as a part of a partial denture panel under 14-I-098 (IRB # 1407637739) or who will wear their own lower partial denture which was previously approved as part of the panel. The study partial dentures or personal partial dentures can house the specimen holders in two hollowed out areas of the buccal surface of two posterior denture teeth. The subjects will wear the lower partial dentures with enamel specimens in place for three consecutive 14-day study periods.
Masking: Triple blind
Who is masked: Care provider, Investigator, Outcomes assessor
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03678012
Sponsor's protocol ID: 1802077294
Status last verified: Sep 2018
First submitted: 7 Sep 2018
Last updated: 19 Sep 2018
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: No plan to share

Publications

Cormode DP, Gao L, Koo H. Emerging Biomedical Applications of Enzyme-Like Catalytic Nanomaterials. Trends Biotechnol. 2018 Jan;36(1):15-29. doi: 10.1016/j.tibtech.2017.09.006. Epub 2017 Oct 26.
PubMed 29102240
Gao L, Liu Y, Kim D, Li Y, Hwang G, Naha PC, Cormode DP, Koo H. Nanocatalysts promote Streptococcus mutans biofilm matrix degradation and enhance bacterial killing to suppress dental caries in vivo. Biomaterials. 2016 Sep;101:272-84. doi: 10.1016/j.biomaterials.2016.05.051. Epub 2016 Jun 2.
PubMed 27294544

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 19 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Anti-biofilm Effects of Ferumoxytol (Feraheme) Using an in Situ Biofilm Demineralization Model
ClinicalTrials.gov ID: NCT03678012
Acronym / sponsor ID: 1802077294
Conditions: Dental Caries
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: University of PennsylvaniaUniversity, hospital or other
Collaborators: Indiana University
Study start: 7 Jun 2018 (actual)
Primary completion: 16 Aug 2018 (actual)
Study completion: 16 Aug 2018 (actual)
First posted: 19 Sep 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (care provider, investigator, outcomes assessor)
Number of arms: 3
Model description: This will be a randomized, crossover, single blind in situ study with three test periods utilizing 16 subjects. The subjects in this study are lower partial denture wearers who have already had a study partial denture made for them as a part of a partial denture panel under 14-I-098 (IRB # 1407637739) or who will wear their own lower partial denture which was previously approved as part of the panel. The study partial dentures or personal partial dentures can house the specimen holders in two hollowed out areas of the buccal surface of two posterior denture teeth. The subjects will wear the lower partial dentures with enamel specimens in place for three consecutive 14-day study periods.

Arm	Type	Receives
Ferumoxytol/Hydrogen peroxide	Active comparator	Drug: Ferumoxytol/Hydrogen peroxide1.5% Ferumoxytol / 3% Hydrogen Peroxide (H2O2) 1:1 ratio
Hydrogen peroxide	Placebo comparator	Drug: Hydrogen PeroxideSham Solution / 3% Hydrogen Peroxide (H2O2) 1:1 ratio
Water	Sham comparator	Drug: WaterSham solution (water; negative control)

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Males and females 18 to 85 years of age and in good general and oral health without any known allergies to commercial dental products;
Evidence of a personally signed and dated informed consent document indicating the subject has been informed of all pertinent aspects of the trial;
Willingness to use the assigned products according to instructions, availability for appointments and likelihood of completing the clinical trial;
Willing to adhere to the study requirements and restrictions;
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.

Key exclusion criteria (24 listed)

Normal salivary flow rate (stimulated and unstimulated flow of ≥ 0.8 mL/min and ≥ 0.2 mL/min, respectively) ascertained from the Screening visit;
Willing and capable of wearing the lower partial denture 24 hours a day for the three, two-week treatment periods. Note: for persons who would otherwise qualify but whose lower partial denture needs repair, the individual may be listed as "pending". Once the partial denture has been repaired and adjusted to fit adequately for the subject to wear the lower partial denture 24 hours a day, the subject may be considered "qualified", complete their minimum 4 to 5 days washout period (of their own fluoridated toothpaste use) and continue with visit 2 in the study;
Absence of significant oral soft tissue pathology and dental caries, based on the dentist's visual examination and at the discretion of the investigator. Note: for persons who would otherwise qualify but who present at screening with dental caries requiring treatment, the individual may be listed as "pending". If the subject completes the restorative work within an acceptable amount of time, the subject may be considered qualified, complete their minimum 4 to 5 day washout period (of their own fluoridated toothpaste use) and continue with visit 2 in the study; and
Adequate oral hygiene (i.e. brush teeth daily and exhibit no signs of oral neglect).
Exclusion Criteria: Subjects presenting with any of the following will not be included in the trial:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ferumoxytol/Hydrogen peroxideAlso: Feraheme1.5% Ferumoxytol / 3% Hydrogen Peroxide (H2O2) 1:1 ratio. Each subject will use this product during one of three treatment periods in the crossover study design.	Drug	Ferumoxytol/Hydrogen peroxide
Hydrogen PeroxideSham Solution / 3% Hydrogen Peroxide (H2O2) 1:1 ratio. Each subject will use this product during one of three treatment periods in the crossover study design.	Drug	Hydrogen peroxide
WaterSham solution (water; negative control). Each subject will use this product during one of three treatment periods in the crossover study design.	Drug	Water

Primary outcome

Biofilm Analyses-cell viability
Time frame: 14 days
The effect of the treatments will be analyzed in terms of biochemical and microbiological composition of the biofilm formed. Colony forming unit (CFU) will be used to quantify the number of viable cells in biofilms.
Biofilm Analysis-extracellular polysaccharides
Time frame: 14 days
Biofilm EPS amount (weight in milligram) will be determined using colorimetric assay.

1 secondary outcome

Assessment of Enamel Demineralization by Means of Surface Microhardness Test (SMH)
Time frame: 14 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2018.
Background: PubMed 29102240Cormode DP, Gao L, Koo H. Emerging Biomedical Applications of Enzyme-Like Catalytic Nanomaterials. Trends Biotechnol. 2018 Jan;36(1):15-29. doi: 10.1016/j.tibtech.2017.09.006. Epub 2017 Oct 26.
Background: PubMed 27294544Gao L, Liu Y, Kim D, Li Y, Hwang G, Naha PC, Cormode DP, Koo H. Nanocatalysts promote Streptococcus mutans biofilm matrix degradation and enhance bacterial killing to suppress dental caries in vivo. Biomaterials. 2016 Sep;101:272-84. doi: 10.1016/j.biomaterials.2016.05.051. Epub 2016 Jun 2.
Individual participant dataSharing planned: No. No plan to share

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Hyun Koo, Ph.D principal investigator

University of Pennsylvania

Domenick Zero, Ph.D principal investigator

Indiana University

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Ferumoxytol/Hydrogen peroxide, Hydrogen Peroxide and Water in people with Dental Caries, run by University of Pennsylvania at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Biofilm Analyses-cell viability (time frame: 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03678012, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2018.