Evaluation of the Fluoride Dose Response Using In Situ Caries Model

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: Completed
• Conditions: Caries
• Intervention / Treatment: Drug: 0 ppm F; Drug: 250 ppm F as MFP; Drug: 1100 ppm as MFP; Drug: 2800 ppm F as MFP; Drug: 1100 ppm SnF2

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Enamel Fluoride Uptake (EFU)	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

Outcome Measure	Measure Description	Time Frame
Enamel Fluoride Uptake (EFU)	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)	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)	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)	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)	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

• Sponsor: Procter and Gamble

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): July 21, 2021
• Study Completion (Actual): July 21, 2021

Study Registration Dates

• First Submitted: February 9, 2021
• First Submitted That Met QC Criteria: February 17, 2021
• First Posted (Actual): February 21, 2021

Study Record Updates

• Last Update Posted (Actual): July 19, 2022
• Last Update Submitted That Met QC Criteria: June 23, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Other Study ID 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