Evaluation of the Fluoride Dose Response Using In Situ Caries Model

Phase 4

Completed

Conditions: Caries

Interventions: Drug: 0 ppm F
Drug: 1100 ppm SnF2
Drug: 250 ppm F as MFP
Drug: 1100 ppm as MFP
Drug: 2800 ppm F as MFP

Registration Number: NCT04763044

Lead Sponsor: Procter and Gamble

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 15

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 & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Period 1	0 ppm F	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)
Period 1	250 ppm F as MFP	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)
Period 2	0 ppm F	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)
Period 2	250 ppm F as MFP	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)
Period 3	0 ppm F	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)
Period 3	250 ppm F as MFP	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)
Period 3	1100 ppm as MFP	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)
Period 4	0 ppm F	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)
Period 4	250 ppm F as MFP	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)
Period 4	1100 ppm as MFP	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)
Period 4	2800 ppm F as MFP	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)
Period 1	1100 ppm as MFP	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)
Period 1	2800 ppm F as MFP	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)
Period 2	2800 ppm F as MFP	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)
Period 5	1100 ppm SnF2	1100 ppm SnF2 toothpaste only
Period 2	1100 ppm as MFP	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)
Period 3	2800 ppm F as MFP	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)

Primary Outcome Measures

Name	Time	Method
Enamel Fluoride Uptake (EFU)	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.

Secondary Outcome Measures

Name	Time	Method
Enamel Fluoride Uptake (EFU)	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.
Percent Surface Microhardness (SMH)	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.