An in Situ Study on the Impact of Fluoride Dose and Concentration in Milk on Its Anti-caries Efficacy

February 3, 2015 updated by: Frank Lippert
The study will be randomized, investigator-blind, observer-blind, laboratory analyst-blind and will utilize a 5-way cross-over study design with a primary objective to determine if a higher dose of fluoride in milk will provide a greater caries preventive effect. Secondary objectives are to determine in a higher concentration of fluoride in milk will provide a greater caries preventive effect and if the caries preventive effect of fluoridated milk follows a dose-response pattern.

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.

Detailed Description

The evidence of milk fluoridation as a public health measure in caries prevention has been demonstrated in many clinical studies. While these data are encouraging, the main focus now should be on the optimization of milk fluoride programs. This protocol will concentrate on the parameters of fluoride dose and concentration utilizing an in situ model, the intra-oral caries test or model (ICT). The ICT is an established model which features the use of gauze-covered specimens to facilitate plaque growth and to simulate a caries-prone/plaque stagnation area. After subject has been consented and enrolled in the study per the inclusion/exclusion criteria, two to three days following a dental cleaning, two partially demineralized specimens will be placed in the buccal flange area of the subject's mandibular partial denture. During each of the five, three-week test periods, subjects will drink their assigned milk test product once per day for either five (100 ml milk) or ten (200 ml milk) timed minutes, wearing their mandibular partial dentures 24 hours a day during the test period. Fluoride free toothpaste will be used two to three days before and continuously during each treatment period. After each three-week test period, the two partially demineralized specimens will be removed from the subject's partial denture and analyzed using the surface microhardness test. Mineral content change (as percentage of surface microhardness recovery) in these artificially induced incipient enamel lesions will be the primary outcome variable. Each subject (n = 28) will serve as his or her own control.

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.
28

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.
  • Not Applicable

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, Indiana University School of Dentistry

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • sign an informed consent, authorization for the release of health information for research and provide medical history information, including medications, prior to their participation;
  • be between 18 and 80 years old and in general good health;
  • willingness to use a reliable form of contraception or abstaining during the course of the study (females of child-bearing potential only)
  • wear a removable mandibular partial denture with sufficient room in one posterior buccal flange area to accommodate two enamel specimens (required dimensions 12×7 mm);
  • be willing and capable of wearing their removable mandibular partial dentures 24 hours a day for a total of five, three-week test periods;
  • be in good dental health with no active caries or periodontal disease;
  • agree to comply with all subjects' responsibilities as stated in the protocol (e.g. use of study products, attendance at appointments, etc.);
  • 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).
  • Be able to tolerate the taste and room temperature of the mixed milk product as demonstrated by drinking the milk at screening

Exclusion Criteria:

be pregnant, intending to become pregnant during the study period or breast feeding. A urine pregnancy test will be required at screening, the start of each treatment visit and the last study visit for all subjects of child-bearing potential to confirm the subject is not pregnant.

  • have any medical condition that could be expected to interfere with the subject's safety during the study period;
  • demonstrate an inability to comply with study procedures;
  • have factors which could contraindicate their participation, such as any condition requiring the need for antibiotic premedication prior to a dental treatment, a condition requiring the need for long-term antibiotic use, blood thinning medications that prohibit the safe conduct of a dental cleaning* or previous use of the weight loss medications Fen Phen® or Redux®. (*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 at the discretion of the Investigator.)
  • be currently taking or have ever taken a bisphosphonate drug (i.e. Fosamax®, Actonel®, Boniva®, Reclast®, or Zometa®) for treatment of osteoporosis.
  • be lactose intolerant or have known allergy or intolerance to milk or milk products

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

  • 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: Arm 1
non-fluoridated milk, 200 ml 1.5 mg sodium fluoride in 100 ml milk, 1.5 mg sodium fluoride in 200 ml milk, 3 mg sodium fluoride in 100 ml milk, 3 mg sodium fluoride in 200 ml milk
Drug: 1.5 mg Sodium Fluoride in 100 ml milk
Each subject will use this product during one of the five treatment periods in the crossover study design.
Other Names:
  • sodium fluoride (PCCA Sodium Fluoride USP 51927-1038-00)
  • Kroger Nonfat Dry Milk reconstituted with fluoride-free milk
Drug: 1.5 mg sodium fluoride in 200 ml milk
Each subject will use this product during one of the five treatment periods in the crossover study design.
Other Names:
  • sodium fluoride (PCCA Sodium Fluoride USP 51927-1038-00)
  • Kroger Nonfat Dry Milk reconstituted with fluoride-free milk
Drug: 3 mg sodium fluoride in 100 ml milk
Each subject will use this product during one of the five treatment periods in the crossover study design.
Other Names:
  • sodium fluoride (PCCA Sodium Fluoride USP 51927-1038-00)
  • Kroger Nonfat Dry Milk reconstituted with fluoride-free milk
Drug: 3 mg sodium fluoride in 200 ml milk
Each subject will use this product during one of the five treatment periods in the crossover study design
Other Names:
  • sodium fluoride (PCCA Sodium Fluoride USP 51927-1038-00)
  • Kroger Nonfat Dry Milk reconstituted with fluoride-free milk
Other: Non-fluoridated milk, 200 ml
Each subject will use this product during one of the five treatment periods in the crossover study design.
Other Names:
  • Kroger Nonfat Dry Milk
Other: Arm 2
non-fluoridated milk, 200 ml 1.5 mg sodium fluoride in 100 ml milk, 1.5 mg sodium fluoride in 200 ml milk, 3 mg sodium fluoride in 100 ml milk, 3 mg sodium fluoride in 200 ml milk
Drug: 1.5 mg Sodium Fluoride in 100 ml milk
Each subject will use this product during one of the five treatment periods in the crossover study design.
Other Names:
  • sodium fluoride (PCCA Sodium Fluoride USP 51927-1038-00)
  • Kroger Nonfat Dry Milk reconstituted with fluoride-free milk
Drug: 1.5 mg sodium fluoride in 200 ml milk
Each subject will use this product during one of the five treatment periods in the crossover study design.
Other Names:
  • sodium fluoride (PCCA Sodium Fluoride USP 51927-1038-00)
  • Kroger Nonfat Dry Milk reconstituted with fluoride-free milk
Drug: 3 mg sodium fluoride in 100 ml milk
Each subject will use this product during one of the five treatment periods in the crossover study design.
Other Names:
  • sodium fluoride (PCCA Sodium Fluoride USP 51927-1038-00)
  • Kroger Nonfat Dry Milk reconstituted with fluoride-free milk
Drug: 3 mg sodium fluoride in 200 ml milk
Each subject will use this product during one of the five treatment periods in the crossover study design
Other Names:
  • sodium fluoride (PCCA Sodium Fluoride USP 51927-1038-00)
  • Kroger Nonfat Dry Milk reconstituted with fluoride-free milk
Other: Non-fluoridated milk, 200 ml
Each subject will use this product during one of the five treatment periods in the crossover study design.
Other Names:
  • Kroger Nonfat Dry Milk
Other: Arm 3
non-fluoridated milk, 200 ml 1.5 mg sodium fluoride in 100 ml milk, 1.5 mg sodium fluoride in 200 ml milk, 3 mg sodium fluoride in 100 ml milk, 3 mg sodium fluoride in 200 ml milk
Drug: 1.5 mg Sodium Fluoride in 100 ml milk
Each subject will use this product during one of the five treatment periods in the crossover study design.
Other Names:
  • sodium fluoride (PCCA Sodium Fluoride USP 51927-1038-00)
  • Kroger Nonfat Dry Milk reconstituted with fluoride-free milk
Drug: 1.5 mg sodium fluoride in 200 ml milk
Each subject will use this product during one of the five treatment periods in the crossover study design.
Other Names:
  • sodium fluoride (PCCA Sodium Fluoride USP 51927-1038-00)
  • Kroger Nonfat Dry Milk reconstituted with fluoride-free milk
Drug: 3 mg sodium fluoride in 100 ml milk
Each subject will use this product during one of the five treatment periods in the crossover study design.
Other Names:
  • sodium fluoride (PCCA Sodium Fluoride USP 51927-1038-00)
  • Kroger Nonfat Dry Milk reconstituted with fluoride-free milk
Drug: 3 mg sodium fluoride in 200 ml milk
Each subject will use this product during one of the five treatment periods in the crossover study design
Other Names:
  • sodium fluoride (PCCA Sodium Fluoride USP 51927-1038-00)
  • Kroger Nonfat Dry Milk reconstituted with fluoride-free milk
Other: Non-fluoridated milk, 200 ml
Each subject will use this product during one of the five treatment periods in the crossover study design.
Other Names:
  • Kroger Nonfat Dry Milk
Other: Arm 4
non-fluoridated milk, 200 ml 1.5 mg sodium fluoride in 100 ml milk, 1.5 mg sodium fluoride in 200 ml milk, 3 mg sodium fluoride in 100 ml milk, 3 mg sodium fluoride in 200 ml milk
Drug: 1.5 mg Sodium Fluoride in 100 ml milk
Each subject will use this product during one of the five treatment periods in the crossover study design.
Other Names:
  • sodium fluoride (PCCA Sodium Fluoride USP 51927-1038-00)
  • Kroger Nonfat Dry Milk reconstituted with fluoride-free milk
Drug: 1.5 mg sodium fluoride in 200 ml milk
Each subject will use this product during one of the five treatment periods in the crossover study design.
Other Names:
  • sodium fluoride (PCCA Sodium Fluoride USP 51927-1038-00)
  • Kroger Nonfat Dry Milk reconstituted with fluoride-free milk
Drug: 3 mg sodium fluoride in 100 ml milk
Each subject will use this product during one of the five treatment periods in the crossover study design.
Other Names:
  • sodium fluoride (PCCA Sodium Fluoride USP 51927-1038-00)
  • Kroger Nonfat Dry Milk reconstituted with fluoride-free milk
Drug: 3 mg sodium fluoride in 200 ml milk
Each subject will use this product during one of the five treatment periods in the crossover study design
Other Names:
  • sodium fluoride (PCCA Sodium Fluoride USP 51927-1038-00)
  • Kroger Nonfat Dry Milk reconstituted with fluoride-free milk
Other: Non-fluoridated milk, 200 ml
Each subject will use this product during one of the five treatment periods in the crossover study design.
Other Names:
  • Kroger Nonfat Dry Milk
Active Comparator: Arm 5
non-fluoridated milk, 200 ml 1.5 mg sodium fluoride in 100 ml milk, 1.5 mg sodium fluoride in 200 ml milk, 3 mg sodium fluoride in 100 ml milk, 3 mg sodium fluoride in 200 ml milk
Drug: 1.5 mg Sodium Fluoride in 100 ml milk
Each subject will use this product during one of the five treatment periods in the crossover study design.
Other Names:
  • sodium fluoride (PCCA Sodium Fluoride USP 51927-1038-00)
  • Kroger Nonfat Dry Milk reconstituted with fluoride-free milk
Drug: 1.5 mg sodium fluoride in 200 ml milk
Each subject will use this product during one of the five treatment periods in the crossover study design.
Other Names:
  • sodium fluoride (PCCA Sodium Fluoride USP 51927-1038-00)
  • Kroger Nonfat Dry Milk reconstituted with fluoride-free milk
Drug: 3 mg sodium fluoride in 100 ml milk
Each subject will use this product during one of the five treatment periods in the crossover study design.
Other Names:
  • sodium fluoride (PCCA Sodium Fluoride USP 51927-1038-00)
  • Kroger Nonfat Dry Milk reconstituted with fluoride-free milk
Drug: 3 mg sodium fluoride in 200 ml milk
Each subject will use this product during one of the five treatment periods in the crossover study design
Other Names:
  • sodium fluoride (PCCA Sodium Fluoride USP 51927-1038-00)
  • Kroger Nonfat Dry Milk reconstituted with fluoride-free milk
Other: Non-fluoridated milk, 200 ml
Each subject will use this product during one of the five treatment periods in the crossover study design.
Other Names:
  • Kroger Nonfat Dry Milk

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
% Surface Microhardness (SMH) Recovery Score Per Each of Five Arms
Time Frame: Three Weeks per each of five arms
  • surface microhardness recovery is a measure of caries lesion remineralization and is calculated using the following equation:
  • SMHr=(D1-R)/(D1-B)×100 B = indentation length of sound enamel specimen at baseline D1 = indentation length after first in vitro demineralization R = indentation length after intra-oral exposure (rehardening).
Three Weeks per each of five arms

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
% Acid Resistance Score Per Each of Five Arms
Time Frame: Three Weeks per each of five arms
% Acid Resistance is a measure of acid resistance of the remineralized caries lesion which is calculated as (D1-D2)/(D1-B)*100%, where B is the indentation length of sound enamel specimen at baseline, D1 is an indentation length after first in vitro demineralization, D2 is an indentation length after second in vitro demineralization.
Three Weeks per each of five arms
Enamel Fluoride Uptake Per Each of Five Arms
Time Frame: Three Weeks per each of five arms
Enamel fluoride uptake is a measure of fluoridation of a caries lesion
Three Weeks per each of five arms

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.
Frank Lippert

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Borrow Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Domenick Zero, DDS, MS, 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

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.
August 1, 2012

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.
April 1, 2013

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.
June 1, 2013

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).
August 7, 2012

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.
August 13, 2012

First Posted (Estimate)

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.
August 16, 2012

Study Record Updates

Last Update Posted (Estimate)

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.
February 23, 2015

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.
February 3, 2015

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.
February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • 12-I-086

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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