Evaluation of the Fluoride Dose Response Using In Situ Caries Model

Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04763044
• Other study ID #: 2020154
• Status: Completed
• Phase: Phase 4
• Start date: March 1, 2021
• Est. completion date: July 21, 2021

Study information

• Verified date: June 2022
• Source: Procter and Gamble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: July 21, 2021
• Est. primary completion date: July 21, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Caries

Intervention

Drug:
• 0 ppm F
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
• 250 ppm F as MFP
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
• 1100 ppm as MFP
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
• 2800 ppm F as MFP
Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
• 1100 ppm SnF2
Each subject will be assigned to this treatment during the fifth period for this crossover study.

Locations

Country	Name	City	State
United States	Oral Health Research Institute	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Procter and Gamble

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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