Clinical trial NCT04763044: Evaluation of the Fluoride Dose Response Using In Situ Caries Model
Official title: Evaluation of the Fluoride Dose Response of MFP Dentifrice Using In Situ Caries Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Caries
Lead sponsor: Procter and Gamble
Sponsor class: INDUSTRY
First posted: 2021-02-21
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Enamel Fluoride Uptake (EFU)
timeFrame: Evaluations will occur after 21 days of product use
Secondary outcomes:
measure: Enamel Fluoride Uptake (EFU)
timeFrame: Evaluations will occur after 7 days of product use
measure: Percent Surface Microhardness (SMH)
timeFrame: Evaluations will occur after 7 days of product use
measure: Enamel Fluoride Uptake (EFU)
timeFrame: Evaluations will occur after 14 days of product use
measure: Percent Surface Microhardness (SMH)
timeFrame: Evaluations will occur after 14 days of product use
measure: Percent Surface Microhardness (SMH)
timeFrame: Evaluations will occur after 21 days of product use
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Oral Health Research Institute
state: Indiana
Study officials:
References: