← Back to Search

Fluoride Dentifrice

Optimized Fluoride Toothpaste for Cavities

Phase 3

Recruiting

Led By Domenick Zero, DDS, MS

Research Sponsored by Indiana University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be wearing a removable mandibular partial denture with sufficient room to accommodate two 4 mm round specimens in the buccal surface of two posterior denture teeth on the same side

Be between 18 and 85 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up two weeks

Awards & highlights

Study Summary

This trial tested whether a special fluoride toothpaste can reduce tooth decay better than regular fluoride toothpaste.

Who is the study for?

This trial is for adults aged 18-85 with good medical and dental health, no active cavities or gum disease, and who wear a lower partial denture. Participants must not be pregnant, breastfeeding, planning to become pregnant during the study, or have conditions that could affect their safety. They should not have taken antibiotics or participated in another clinical study within the last 30 days.Check my eligibility

What is being tested?

The study aims to compare an optimized fluoride toothpaste (1100 ppm F as sodium fluoride Test Product) against a standard fluoride toothpaste (1100 ppm F as sodium fluoride) and a placebo without fluoride (0 ppm F). It will assess which better promotes remineralization of teeth using an in situ caries model.See study design

What are the potential side effects?

Since this trial involves commonly used dental products like toothpaste, side effects are expected to be minimal. However, there may be potential risks of hypersensitivity reactions if participants are allergic to any ingredients in the test products.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I wear a removable lower jaw denture that can fit two small samples on the inside of back teeth on one side.

Select...

I am between 18 and 85 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ two weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~two weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and two weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percent Surface Microhardness Recovery (%SMH Recovery)

Secondary outcome measures

Enamel Fluoride Uptake (µg F/cm2)

Integrated Mineral Loss (∆Z)

Lesion Depth (µm)

+3 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: Treatment Period 3Experimental Treatment3 Interventions

0 ppm F (placebo, negative control,1100 ppm F as sodium fluoride (positive control), 1100 ppm F as sodium fluoride Test Product

Group II: Treatment Period 2Experimental Treatment3 Interventions

0 ppm F (placebo, negative control,1100 ppm F as sodium fluoride (positive control), 1100 ppm F as sodium fluoride Test Product

Group III: Treatment Period 1Experimental Treatment3 Interventions

0 ppm F (placebo, negative control,1100 ppm F as sodium fluoride (positive control), 1100 ppm F as sodium fluoride Test Product

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

0 ppm F (placebo, negative control)

2017

Completed Phase 3

~30

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor

980 Previous Clinical Trials

982,917 Total Patients Enrolled

HALEONIndustry Sponsor

27 Previous Clinical Trials

3,671 Total Patients Enrolled

Domenick Zero, DDS, MSPrincipal InvestigatorIndiana University

1 Previous Clinical Trials

28 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research program accept volunteers over the age of forty?

"This medical trial is currently taking in participants who are between 18 years and 85 years of age."

Answered by AI

Could I potentially qualify to join this experiment?

"This medical study is seeking 65 participants aged between 18 and 85 who have been diagnosed with cavities."

Answered by AI

Is there still an opportunity to join this research project?

"According to clinicaltrials.gov, this research study is no longer recruiting participants as of August 30th 2023. Although registration has closed for this trial, other medical studies are still actively seeking volunteers right now."

Answered by AI

Is there a notable risk associated with Treatment Period 1?

"Treatment Period 1 has plenty of clinical evidence to suggest its safety, so it scored a 3 on our team's scale. The Phase 3 status signifies that the medication is well-researched with multiple rounds data confirming efficacy and security."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

In Situ Comparison of the Remineralization Potential of Optimized Fluoride Dentifrice With Control Fluoride Dentifrice

Domenick Zero 2023. "In Situ Comparison of the Remineralization Potential of Optimized Fluoride Dentifrice With Control Fluoride Dentifrice". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06010732.