Dental Caries
Conditions
Brief summary
To evaluate the effects of a clinically approved and commercially available iron oxide formulation Ferumoxytol (Feraheme®) to control cariogenic biofilms and enamel demineralization. This study will be testing topical application of Ferumoxytol extra-orally using a standard in situ biofilm demineralization model.
Detailed description
This will be a randomized, crossover, single blind in situ study with three test periods utilizing 16 subjects. The subjects in this study are lower partial denture wearers who have already had a study partial denture made for them as a part of a partial denture panel under 14-I-098 (IRB # 1407637739) or who will wear their own lower partial denture which was previously approved as part of the panel. The study partial dentures or personal partial dentures can house the specimen holders in two hollowed out areas of the buccal surface of two posterior denture teeth. The subjects will wear the lower partial dentures with enamel specimens in place for three consecutive 14-day study periods.
Interventions
DRUGFerumoxytol/Hydrogen peroxide
1.5% Ferumoxytol / 3% Hydrogen Peroxide (H2O2) 1:1 ratio. Each subject will use this product during one of three treatment periods in the crossover study design.
Sham Solution / 3% Hydrogen Peroxide (H2O2) 1:1 ratio. Each subject will use this product during one of three treatment periods in the crossover study design.
DRUGWater
Sham solution (water; negative control). Each subject will use this product during one of three treatment periods in the crossover study design.
Sponsors
Indiana University
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Masking description
The study dentist, specimen/sample analysis technicians and the statistician will be blinded to the product allocation of subjects.
Intervention model description
This will be a randomized, crossover, single blind in situ study with three test periods utilizing 16 subjects. The subjects in this study are lower partial denture wearers who have already had a study partial denture made for them as a part of a partial denture panel under 14-I-098 (IRB # 1407637739) or who will wear their own lower partial denture which was previously approved as part of the panel. The study partial dentures or personal partial dentures can house the specimen holders in two hollowed out areas of the buccal surface of two posterior denture teeth. The subjects will wear the lower partial dentures with enamel specimens in place for three consecutive 14-day study periods.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
1. Males and females 18 to 85 years of age and in good general and oral health without any known allergies to commercial dental products; 2. Evidence of a personally signed and dated informed consent document indicating the subject has been informed of all pertinent aspects of the trial; 3. Willingness to use the assigned products according to instructions, availability for appointments and likelihood of completing the clinical trial; 4. Willing to adhere to the study requirements and restrictions; 5. Lower partial denture wearers who have a lower partial denture made for them as a part of a partial denture panel under study 14-I-098 (IRB # 1407637739) or who agree to wear their own pre-approved lower partial denture that can house both specimens on one side of their partial denture.
Exclusion criteria
Oral Examination Inclusion Criteria: 1. Normal salivary flow rate (stimulated and unstimulated flow of ≥ 0.8 mL/min and ≥ 0.2 mL/min, respectively) ascertained from the Screening visit; 2. Willing and capable of wearing the lower partial denture 24 hours a day for the three, two-week treatment periods. Note: for persons who would otherwise qualify but whose lower partial denture needs repair, the individual may be listed as pending. Once the partial denture has been repaired and adjusted to fit adequately for the subject to wear the lower partial denture 24 hours a day, the subject may be considered qualified, complete their minimum 4 to 5 days washout period (of their own fluoridated toothpaste use) and continue with visit 2 in the study; 3. Absence of significant oral soft tissue pathology and dental caries, based on the dentist's visual examination and at the discretion of the investigator. Note: for persons who would otherwise qualify but who present at screening with dental caries requiring treatment, the individual may be listed as pending. If the subject completes the restorative work within an acceptable amount of time, the subject may be considered qualified, complete their minimum 4 to 5 day washout period (of their own fluoridated toothpaste use) and continue with visit 2 in the study; and 4. Adequate oral hygiene (i.e. brush teeth daily and exhibit no signs of oral neglect).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biofilm Analysis-extracellular polysaccharides | 14 days | Biofilm EPS amount (weight in milligram) will be determined using colorimetric assay. |
| Biofilm Analyses-cell viability | 14 days | The effect of the treatments will be analyzed in terms of biochemical and microbiological composition of the biofilm formed. Colony forming unit (CFU) will be used to quantify the number of viable cells in biofilms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Enamel Demineralization by Means of Surface Microhardness Test (SMH) | 14 days | The surface microhardness (SMH, length in micrometer) test will be used to assess changes in the mineral status of enamel specimens. |
Countries
United States
Outcome results
None listed