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

April 23, 2024 updated by: Domenick Zero, Indiana University

Comparison of the Remineralization Potential of an Optimized Fluoride Dentifrice With a Control Fluoride Dentifrice Using an in Situ Caries Model

The purpose of this study is to compare the remineralization potential of an optimized fluoride dentifrice to a control fluoride dentifrice in an in situ caries model.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This will be a double blind, single center, 3-way crossover design study. Two to three days before the start of each treatment period the subjects will have their teeth cleaned to remove all accessible plaque and calculus and will be provided with a non-fluoride dentifrice to use until their next visit. At the beginning of each testing period, two gauze-covered 4 mm round partially demineralized bovine enamel specimens will be placed in the buccal surface of two posterior denture teeth (the specimen site may extend into the buccal flange area, if needed) of the same side of the partial denture. Once specimens are placed, subjects will wear their partial dentures twenty-four hours a day and use their assigned toothpaste twice daily, as instructed, until their next visit. Specimens will be removed after two weeks, and the subjects will undergo at least a four- to five-day washout period followed by another cleaning and two to three day lead in period. This process will be repeated until all subjects have used all three test products. Changes in the mineral content of the enamel specimens will be assessed using surface microhardness (SMH) and transverse microradiography (TMR). Enamel fluoride uptake (EFU) will be determined using the microdrill enamel biopsy technique. In addition, the net acid resistance (NAR) and the comparative acid resistance (CAR) of the demineralized enamel specimens will be determined.

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University School of dentistry, Oral Health Research institute 415 Lansing Street

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. provide voluntary, written informed consent;
  2. be between 18 and 85 years old;
  3. understand and be willing, able and likely to comply with all study procedures and restrictions;
  4. 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;
  5. be willing and capable of wearing their removable partial denture 24 hours a day for three (3), two-week treatment periods;
  6. be willing to allow study personnel to drill specimen sites in two denture teeth in the posterior section of one side of their lower partial denture, which may extend into the buccal flange area below the teeth;
  7. be in good medical and dental health with no active caries or periodontal disease; NOTE: subjects presenting at screening with caries may continue in the study if their carious lesions are restored prior to beginning treatment 1; and
  8. have a salivary flow rate in the range of normal values (unstimulated whole saliva flow rate ≥ 0.2 mL/min; gum base stimulated whole saliva flow rate ≥ 0.8 mL/min).

Exclusion Criteria:

  1. currently be pregnant, intending to become pregnant during the study period or breast feeding;
  2. currently have any medical condition that could be expected to interfere with the subject's safety during the study period;
  3. currently be taking antibiotics or have taken antibiotics in the two weeks prior to the beginning treatment 1;
  4. known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients;
  5. have participated in another clinical study or receipt of an investigational drug within 30 days of beginning treatment 1; or
  6. be taking fluoride supplements, required to use a fluoride mouthrinse or have received a professional fluoride treatment in the two weeks preceding specimen placement.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Treatment Period 1
0 ppm F (placebo, negative control,1100 ppm F as sodium fluoride (positive control), 1100 ppm F as sodium fluoride Test Product
Drug: 0 ppm F (placebo, negative control)
• Each subject will use this product during one of the three treatment periods in the crossover study design.
Other Names:
  • Tom's of Maine Silly Strawberry
Drug: 1100 ppm F as sodium fluoride (positive control)
• Each subject will use this product during one of the three treatment periods in the crossover study design.
Other Names:
  • Crest Cavity Protection Toothpaste
Drug: 1100 ppm F as sodium fluoride Test Product
• Each subject will use this product during one of the three treatment periods in the crossover study design.
Other Names:
  • Pronamel Daily Protection
Other: Treatment Period 2
0 ppm F (placebo, negative control,1100 ppm F as sodium fluoride (positive control), 1100 ppm F as sodium fluoride Test Product
Drug: 0 ppm F (placebo, negative control)
• Each subject will use this product during one of the three treatment periods in the crossover study design.
Other Names:
  • Tom's of Maine Silly Strawberry
Drug: 1100 ppm F as sodium fluoride (positive control)
• Each subject will use this product during one of the three treatment periods in the crossover study design.
Other Names:
  • Crest Cavity Protection Toothpaste
Drug: 1100 ppm F as sodium fluoride Test Product
• Each subject will use this product during one of the three treatment periods in the crossover study design.
Other Names:
  • Pronamel Daily Protection
Other: Treatment Period 3
0 ppm F (placebo, negative control,1100 ppm F as sodium fluoride (positive control), 1100 ppm F as sodium fluoride Test Product
Drug: 0 ppm F (placebo, negative control)
• Each subject will use this product during one of the three treatment periods in the crossover study design.
Other Names:
  • Tom's of Maine Silly Strawberry
Drug: 1100 ppm F as sodium fluoride (positive control)
• Each subject will use this product during one of the three treatment periods in the crossover study design.
Other Names:
  • Crest Cavity Protection Toothpaste
Drug: 1100 ppm F as sodium fluoride Test Product
• Each subject will use this product during one of the three treatment periods in the crossover study design.
Other Names:
  • Pronamel Daily Protection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Surface Microhardness Recovery (%SMH Recovery)
Time Frame: Two weeks

The SMH test will be used to assess changes in the mineral status of partially demineralized enamel specimens.

%SMH Recovery = (D1-R)/(D1-B) ×100 B = indentation length (µm) of sound enamel specimen at baseline D1 = indentation length (µm) after in vitro demineralization R = indentation length (µm) after intra-oral exposure.
Two weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Enamel Fluoride Uptake (µg F/cm2)
Time Frame: Two weeks
The microdrill enamel biopsy technique will be used to analyze the fluoride content of the partially demineralized enamel specimens. Each enamel specimen will be mounted perpendicular to the long axis of a drill bit attached to a specially designed microdrill and drilled to a depth of ~100 µm through the entire lesion (four cores per specimen). The diameter of the drill hole will be determined using a calibrated microscope interfaced with an image analysis system. The amount of fluoride-uptake by enamel will be calculated based on the amount of fluoride divided by the area of the enamel cores and expressed as µg F/cm2
Two weeks
Percent Net Acid Resistance
Time Frame: Two weeks
% Net Acid Resistance = [(D1-D2) / (D1-B)] * 100 B= Indentation length (µm) of sound enamel at baseline D1= Indentation length (µm) after first in vitro demineralization D2= Indentation length (µm) after second in vitro demineralization
Two weeks
Percentage Comparative Acid Resistance
Time Frame: Two weeks
% Comparative Acid Resistance = [(D2-R) / (D1-B)] * 100 B= Indentation length (µm) of sound enamel at baseline R= Indentation length (µm) of enamel after in situ remineralization D1= Indentation length (µm) after first in vitro demineralization D2= Indentation length (µm) after second in vitro demineralization
Two weeks
Integrated Mineral Loss (∆Z)
Time Frame: Two weeks
∆Z= [(lesion depth x 87) - area under the curve*] calculated using Transverse Microradiography software program
Two weeks
Lesion Depth (µm)
Time Frame: Two weeks
Lesion Depth - L (83% mineral i.e. 95% of the mineral content of sound enamel) determined using Transverse Microradiography software program
Two weeks
Maximum mineral density at the surface-zone (SZmax)
Time Frame: Two weeks
SZmax will be determined using Transverse Microradiography software program
Two weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Collaborators

HALEON

Investigators

  • Principal Investigator: Anderson Hara, DDS, PhD, Indiana University
  • Principal Investigator: Domenick Zero, DDS, MS, Indiana University
  • Principal Investigator: Frank Lippert, PhD, Indiana University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 2, 2023

Primary Completion (Actual)

February 8, 2024

Study Completion (Actual)

February 22, 2024

Study Registration Dates

First Submitted

August 17, 2023

First Submitted That Met QC Criteria

August 22, 2023

First Posted (Actual)

August 25, 2023

Study Record Updates

Last Update Posted (Actual)

April 25, 2024

Last Update Submitted That Met QC Criteria

April 23, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-I-121

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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