The aim of this study is to evaluate the relative efficacy of an experimental dentifrice containing 1150 parts per million (ppm) fluoride (as sodium fluoride \[NaF\]) to remineralize early stage caries type lesions in an in situ model compared to a negative control and a reference dentifrice.
This is a randomized, single-blind, single-center, controlled, three period, three treatment, cross-over caries in situ model in healthy participants who wear a suitable removable mandibular partial denture. The denture will be modified to accommodate 2 gauze-covered, 4 millimeter (mm) round specimens of bovine dental enamel that have been previously demineralized in vitro to form artificial caries lesions. After 14 days of twice daily product use off-site, the specimens will be removed at the study site to determine the remineralization ability of the treatments. The same procedure will be followed for period 2 and 3 with a washout period of 2-3 days prior to each treatment period. Sufficient participants will be screened to randomize up to 50 participants to the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
47
Dentifrice containing 5 percent (%) weight by weight (w/w) Potassium nitrate (KNO3) and 1150ppm fluoride as sodium fluoride.
Dentifrice containing 1100ppm fluoride as stannous fluoride.
Dentifrice containing 5% KNO3 with no fluoride.
Oral Health Research Institute
Indianapolis, Indiana, United States
Percent Surface Microhardness Recovery (%SMHr) After 2 Weeks in situ (Experimental Dentifrice Versus [Vs] Negative Control Dentifrice)
The Surface Microhardness (SMH) technique is used to detect changes in the mineral content of dental enamel. The %SMHr will be derived as \[(D1-R)/(D1-B)\]\*100, where D1= mean of replicate indentation lengths (micrometer \[μm\]) in enamel after first in vitro demineralization, R= mean of replicate indentation lengths (μm) in enamel after 2-weeks in situ and B= mean of replicate indentation lengths (μm) in sound enamel at baseline.
Time frame: After 2 Weeks in situ in each Treatment Period
%SMHr After 2 Weeks in situ (Experimental Dentifrice Vs Reference Dentifrice)
The SMH technique is used to detect changes in the mineral content of dental enamel. The %SMHr will be derived as \[(D1-R)/(D1-B)\]\*100, where D1= mean of replicate indentation lengths (μm) in enamel after first in vitro demineralization, R= mean of replicate indentation lengths (μm) in enamel after 2-weeks in situ and B= mean of replicate indentation lengths (μm) in sound enamel at baseline.
Time frame: After 2 Weeks in situ in each Treatment Period
%SMHr After 2 Weeks in situ (Reference Dentifrice Vs Negative Control Dentifrice)
The SMH technique is used to detect changes in the mineral content of dental enamel. The %SMHr will be derived as \[(D1-R)/(D1-B)\]\*100, where D1= mean of replicate indentation lengths (μm) in enamel after first in vitro demineralization, R= mean of replicate indentation lengths (μm) in enamel after 2-weeks in situ and B= mean of replicate indentation lengths (μm) in sound enamel at baseline.
Time frame: After 2 Weeks in situ in each Treatment Period
Transverse Microradiography (TMR) Parameter - Integrated Mineral Loss (∆Z) After 2 Weeks in situ
Integrated Mineral Loss will be determined using TMR. TMR measures changes in mineral content by cutting the enamel specimens into plano-parallel thin slices and taking digitized microradiographic images of each. The mineral content is calculated from the gray intensity levels of the images of section.
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Time frame: After 2 Weeks in situ in each Treatment Period
TMR Parameter - Lesion Depth (L) After 2 Weeks in situ
Lesion depth will be determined using TMR. TMR measures changes in mineral content by cutting the enamel specimens into plano-parallel thin slices and taking digitized microradiographic images of each. The mineral content is calculated from the gray intensity levels of the images of section.
Time frame: After 2 Weeks in situ in each Treatment Period
TMR Parameter - Maximum Mineral Density at the Surface Zone (SZmax) After 2 Weeks in situ
Maximum mineral density at the surface zone will be determined using TMR. TMR measures changes in mineral content by cutting the enamel specimens into plano-parallel thin slices and taking digitized microradiographic images of each. The mineral content is calculated from the gray intensity levels of the images of section.
Time frame: After 2 Weeks in situ in each Treatment Period
Enamel Fluoride Uptake (EFU) After 2 Weeks in situ
EFU gives valuable information regarding how much fluoride is incorporated into a remineralized lesion. In this technique the enamel is sampled through use of a microdrill to obtain a quantity of powdered enamel representative of the cross section through the lesion. The powder is dissolved in acid and chemically analyzed for fluoride.
Time frame: After 2 Weeks in situ in each Treatment Period
Percent Net Acid Resistance (%NAR) After 2 Weeks in situ and Further in vitro Demineralization
The resistance to acid-induced demineralization will be assessed through NAR. The %NAR (at the specimen level) will be derived as \[(D1-D2)/(D1-B)\]\*100, where D1= mean of replicate indentation lengths (μm) in enamel after first in vitro demineralization, D2= mean of replicate indentation lengths (μm) in enamel after the second in vitro demineralization and B= mean of replicate indentation lengths (μm) in sound enamel at baseline.
Time frame: After 2 Weeks in situ in each Treatment Period
Acid Resistance Ratio (ARR) After 2 Weeks in situ and Further in vitro Demineralization
The resistance to acid-induced demineralization will be assessed through ARR. The ARR will be derived as 1-\[(D2-R)/(D1-B)\] where, D2= mean of replicate indentation lengths (μm) in enamel after the second in vitro demineralization, R= mean of replicate indentation lengths (μm) in enamel after 2-weeks in situ, D1= mean of replicate indentation lengths (μm) in enamel after first in vitro demineralization and B= mean of replicate indentation lengths (μm) in sound enamel at baseline.
Time frame: After 2 Weeks in situ in each Treatment Period