Evaluation of the Fluoride Dose Response Using In Situ Caries Model

June 23, 2022 updated by: Procter and Gamble

Evaluation of the Fluoride Dose Response of MFP Dentifrice Using In Situ Caries Model

The purpose of this study is to evaluate the fluoride dose response of different dentifrice fluoride concentrations - 0, 250, 1100 and 2800 ppm fluoride as sodium monofluorophosphate (MFP) and a fifth leg of 1100 ppm Stannous Fluoride (SnF2) using an in situ caries model.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

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

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Oral Health Research Institute

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Be between 18 and 85 years of age;
  • Provide written informed consent prior to participation and be given a signed copy of the informed consent form;
  • Be in general good health as determined by the Investigator based on a review of the health history/update for participation in the trial;
  • Be wearing a removable mandibular partial denture with sufficient room in one posterior buccal flange area to accommodate two 4 mm round enamel specimens and room on the same side to accommodate two 4 mm round specimens in the buccal surface of two posterior denture teeth;
  • Be willing and capable of wearing their removable partial denture 24 hours a day for four (4), three-week treatment periods;
  • Be willing to allow study personnel to drill specimen sites (as described in #iv) in their mandibular partial denture;
  • 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);
  • 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:

  • Currently being pregnant, intending to become pregnant during the study period, or breast feeding;
  • Currently having any medical condition that could be expected to interfere with the subject's safety during the study period;
  • Currently taking antibiotics or having taken antibiotics in the two weeks prior to beginning treatment 1;
  • Having participated in another clinical study or receipt of an investigational drug within 30 days of beginning treatment 1; or
  • Taking fluoride supplements, required to use a fluoride mouth rinse, or have received a professional fluoride treatment in the two weeks preceding specimen placement;
  • Currently taking or have ever taken bisphosphonate drugs (e.g., Fosamax, Actonel and Boniva) for the treatment of osteoporosis.

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: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Period 1
0 ppm F (placebo, negative control), 250 ppm F as MFP (dose-response control), 1100 ppm F as MFP (reference), 2800 ppm F as MFP (dose-response control)
Drug: 0 ppm F
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
Drug: 250 ppm F as MFP
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
Drug: 1100 ppm as MFP
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
Drug: 2800 ppm F as MFP
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
Other: Period 2
0 ppm F (placebo, negative control), 250 ppm F as MFP (dose-response control), 1100 ppm F as MFP (reference), 2800 ppm F as MFP (dose-response control)
Drug: 0 ppm F
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
Drug: 250 ppm F as MFP
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
Drug: 1100 ppm as MFP
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
Drug: 2800 ppm F as MFP
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
Other: Period 3
0 ppm F (placebo, negative control), 250 ppm F as MFP (dose-response control), 1100 ppm F as MFP (reference), 2800 ppm F as MFP (dose-response control)
Drug: 0 ppm F
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
Drug: 250 ppm F as MFP
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
Drug: 1100 ppm as MFP
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
Drug: 2800 ppm F as MFP
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
Other: Period 4
0 ppm F (placebo, negative control), 250 ppm F as MFP (dose-response control), 1100 ppm F as MFP (reference), 2800 ppm F as MFP (dose-response control)
Drug: 0 ppm F
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
Drug: 250 ppm F as MFP
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
Drug: 1100 ppm as MFP
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
Drug: 2800 ppm F as MFP
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
Other: Period 5
1100 ppm SnF2 toothpaste only
Drug: 1100 ppm SnF2
Each subject will be assigned to this treatment during the fifth period for this crossover study.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Enamel Fluoride Uptake (EFU)
Time Frame: Evaluations will occur after 21 days of product use
The EFU test will evaluate the level of fluoride in partially demineralized enamel specimens via the microdrill enamel biopsy technique by [Sakkab et al., 1984]. The calculated scores will be measured in μg F/cm2.
Evaluations will occur after 21 days of product use

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Enamel Fluoride Uptake (EFU)
Time Frame: Evaluations will occur after 7 days of product use
The EFU test will evaluate the level of fluoride in partially demineralized enamel specimens via the microdrill enamel biopsy technique by [Sakkab et al., 1984]. The calculated scores will be measured in μg F/cm2.
Evaluations will occur after 7 days of product use
Percent Surface Microhardness (SMH)
Time Frame: Evaluations will occur after 7 days of product use
The SMH test will evaluate changes in the mineral status of partially demineralized enamel specimens through use of a Wilson 2100 Hardness Tester. These scores will be calculated as a percent.
Evaluations will occur after 7 days of product use
Enamel Fluoride Uptake (EFU)
Time Frame: Evaluations will occur after 14 days of product use
The EFU test will evaluate the level of fluoride in partially demineralized enamel specimens via the microdrill enamel biopsy technique by [Sakkab et al., 1984]. The calculated scores will be measured in μg F/cm2.
Evaluations will occur after 14 days of product use
Percent Surface Microhardness (SMH)
Time Frame: Evaluations will occur after 14 days of product use
The SMH test will evaluate changes in the mineral status of partially demineralized enamel specimens through use of a Wilson 2100 Hardness Tester. These scores will be calculated as a percent.
Evaluations will occur after 14 days of product use
Percent Surface Microhardness (SMH)
Time Frame: Evaluations will occur after 21 days of product use
The SMH test will evaluate changes in the mineral status of partially demineralized enamel specimens through use of a Wilson 2100 Hardness Tester. These scores will be calculated as a percent.
Evaluations will occur after 21 days of product use

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Procter and Gamble

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 21, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 21, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 9, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 21, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 19, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2020154

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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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