Evaluation of the Fluoride Dose Response Using In Situ Caries Model

NCT04763044 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 2020154
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Caries

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Enamel Fluoride Uptake (EFU)

  Evaluations will occur after 7 days of product use

• Percent Surface Microhardness (SMH)

  Evaluations will occur after 7 days of product use

• Enamel Fluoride Uptake (EFU)

  Evaluations will occur after 14 days of product use

• Percent Surface Microhardness (SMH)

  Evaluations will occur after 14 days of product use

• Percent Surface Microhardness (SMH)

  Evaluations will occur after 21 days of product use

Study Arms (5)

Period 1

OTHER

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; Drug: 250 ppm F as MFP; Drug: 1100 ppm as MFP; Drug: 2800 ppm F as MFP

Period 2

OTHER

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; Drug: 250 ppm F as MFP; Drug: 1100 ppm as MFP; Drug: 2800 ppm F as MFP

Period 3

OTHER

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; Drug: 250 ppm F as MFP; Drug: 1100 ppm as MFP; Drug: 2800 ppm F as MFP

Period 4

OTHER

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; Drug: 250 ppm F as MFP; Drug: 1100 ppm as MFP; Drug: 2800 ppm F as MFP

Period 5

OTHER

1100 ppm SnF2 toothpaste only

Drug: 1100 ppm SnF2

Interventions

0 ppm F DRUG

Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.

Period 1; Period 2; Period 3; Period 4

250 ppm F as MFP DRUG

Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.

Period 1; Period 2; Period 3; Period 4

1100 ppm as MFP DRUG

Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.

Period 1; Period 2; Period 3; Period 4

2800 ppm F as MFP DRUG

Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.

Period 1; Period 2; Period 3; Period 4

1100 ppm SnF2 DRUG

Each subject will be assigned to this treatment during the fifth period for this crossover study.

Period 5

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Procter and Gamble: lead

Study Sites (1)

Oral Health Research Institute

Indianapolis, Indiana, 46202, United States

Location

Results Point of Contact

• Title: Clinical Trial Manager
• Organization: Procter & Gamble

peters.j.2@pg.com

513-622-2489

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Fifth leg of the study will not be randomized, participants will remain blinded but all will use the same product.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2021
• First Posted: February 21, 2021
• Study Start: March 1, 2021
• Primary Completion: July 21, 2021
• Study Completion: July 21, 2021
• Last Updated: July 19, 2022
• Results First Posted: July 19, 2022

Record last verified: 2022-06

Locations

US (1)