INDIANAPOLIS, IN, United States
INDIANAPOLIS, IN, United States

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Mathews M.S.,University of Texas Health Science Center at San Antonio | Amaechi B.T.,University of Texas Health Science Center at San Antonio | Ramalingam K.,University of Texas Health Science Center at San Antonio | Ccahuana-Vasquez R.A.,University of Texas Health Science Center at San Antonio | And 3 more authors.
Archives of Oral Biology | Year: 2012

Objective: The purpose of this pilot study was to evaluate the remineralisation of eroded enamel by NaF rinses in an intra-oral model. Methods: Serving as their own control, subjects (N = 80) participated in a randomised, four-leg (20 subjects/leg), 28-day, parallel design study. In each leg, each participant wore a customised orthodontic bracket attached to a mandibular molar that contained one tooth block having an initial erosive lesion (0.3% citric acid, pH 3.75, 2 h). Within the 28-day period, participants engaged in twice-daily brushing for 1 min with a fluoride-free dentifrice followed by 1-min rinsing with one of the following aqueous rinses: fluoride-free (0 ppm F), 225 ppm F, 225 ppm F plus functionalised β-tricalcium phosphate (fTCP), and 450 ppm F. Following intra-oral exposure, appliances were removed and specimens were analysed using surface microhardness (SMH) and transverse microradiography (TMR). Results: Statistically significant (p < 0.05) remineralisation, as determined by SMH and TMR, of the eroded enamel relative to baseline occurred for each fluoride system. No significant differences in SMH were observed amongst the fluoride groups (p > 0.05), however, 225 ppm plus fTCP produced 27% and 7% SMH indent length reduction relative to 225 ppm F and 450 ppm F, respectively. No significant differences in TMR were observed amongst the fluoride groups (p > 0.05), however, 225 ppm F plus fTCP and 450 ppm F produced significant (p < 0.05) mineral gains relative to the fluoride-free control, whilst 225 ppm F did not (p > 0.05). Relative to the 225 ppm F group, the 450 ppm F and 225 ppm F plus fTCP groups produced 65% and 61% greater mineral change, respectively. Conclusions: These pilot results demonstrate this model is sensitive to fluoride and that addition of fTCP to an aqueous rinse containing 225 ppm F may provide significant remineralisation benefits. Therefore, the combination of relatively low levels of fluoride and fTCP might be an effective alternative to a high fluoride treatment for anti-erosion benefits. © 2011 Elsevier Ltd.


Karlinsey R.L.,Indiana Nanotech, Llc | Mackey A.C.,Indiana Nanotech, Llc | Dodge L.E.,Indiana Nanotech, Llc | Schwandt C.S.,McCrone Associates Inc.
Journal of Dentistry for Children | Year: 2014

Purpose: Fluoride varnishes are appealing topical fluoride preparations that may provide anticaries benefits. The purpose of this in vitro study was to assess the noncontact remineralization effects of a commercial 5% sodium fluoride varnish on white spot lesions (WSLs). Methods: Three-millimeter diameter enamel cores were extracted from bovine teeth, mounted in acrylic rods, ground and polished, and initially demineralized to create WSLs. Specimens were evaluated for surface microhardness and divided (n=6) into two groups (water control or noncontact 5% sodium fluoride white varnish with tricalcium phosphate, where one 0.50 ml unit dose was applied to acrylic rods instead of directly on WSLs). Groups were cycled in a three-day regimen consisting of two rounds of one-hour treatments and one-hour static immersions in demineralization solution. Between these events, WSLs were immersed in artificial saliva. Remineralization was evaluated using surface and cross-sectional microhardness and high-resolution scanning electron microscopy (SEM). Results: The noncontact varnish treatment produced significantly greater percent surface microhardness recoveries (P<.05) and smaller subsurface lesions compared to the control group (P<.05). SEM revealed comparatively greater WSL porosity reduction for noncontact varnish. Conclusions: Noncontact application of a commercial 5% sodium fluoride varnish reduced white spot lesion porosity and produced significant acid-resistant white spot lesion remineralization.


Karlinsey R.L.,Indiana Nanotech, Llc
Advances in dental research | Year: 2012

With more than 50 years of clinical success, fluoride serves as the gold standard agent for preventing tooth decay. In particular, the action of fluoride facilitates saliva-driven remineralization of demineralized enamel and alters solubility beneficially. Still, tooth decay remains problematic, and one way to address it may be through the development of new mineralizing agents. Laboratory and clinical studies have demonstrated that the combination of fluoride and functionalized β-tricalcium phosphate (fTCP) produces stronger, more acid-resistant mineral relative to fluoride, native β-TCP, or fTCP alone. In contrast to other calcium-based approaches that seem to rely on high levels of calcium and phosphate to drive remineralization, fTCP is a low-dose system designed to fit within existing topical fluoride preparations. The functionalization of β-TCP with organic and/or inorganic molecules provides a barrier that prevents premature fluoride-calcium interactions and aids in mineralization when applied via common preparations and procedures. While additional clinical studies are warranted, supplementing with fTCP to enhance fluoride-based nucleation activity, with subsequent remineralization driven by dietary and salivary calcium and phosphate, appears to be a promising approach.


Karlinsey R.L.,Indiana Nanotech, Llc | Mackey A.C.,Indiana Nanotech, Llc | Walker E.R.,Indiana Nanotech, Llc | Frederick K.E.,Indiana Nanotech, Llc
Acta Biomaterialia | Year: 2010

A blended material composed of beta-tricalcium phosphate (β-TCP) and fumaric acid (FA) was prepared using a mechanochemical process. The structure and properties of the TCP-FA material was probed using particle size analysis, infrared, 31P and 13C solid-state nuclear magnetic resonance (NMR) spectroscopy, powder X-ray diffraction and calcium bioavailability. NMR studies showed that orthophosphate environments within β-TCP remain largely unaffected in the presence of FA during mechanochemical processing; alternately, 13C data indicated the carboxylic groups of FA are strongly affected during processing with β-TCP. X-ray results reveal β-TCP diffraction plane shifting with lattice contractions likely arising at the C3 symmetry site. While milled β-TCP (mTCP) produces a higher flux of bioavailable calcium relative to native β-TCP, the mechanochemical conditioning of TCP-FA generates more than seven times the level of ionic calcium relative to mTCP. Collectively, the results from these studies indicate FA interfaces with calcium oxide polyhedra of the β-TCP hexagonal crystal lattice, especially with the underbonded CaO3 cluster manifested within the C3 symmetry site of the β-TCP motif. An in vitro remineralization/demineralization pH cycling dental model was then used to assess the potential of the TCP-FA material in reversing early stage non-cavitated enamel lesions. Characterization of the remineralization via surface and longitudinal microhardness measurements demonstrated that the TCP-FA material provides statistically superior remineralization relative to milled and native β-TCP. © 2009 Acta Materialia Inc.


Karlinsey R.L.,Indiana Nanotech, Llc | MacKey A.C.,Indiana Nanotech, Llc | Walker E.R.,Indiana Nanotech, Llc | Frederick K.E.,Indiana Nanotech, Llc
Journal of Materials Science: Materials in Medicine | Year: 2010

A hybrid material comprised of beta-tricalcium phosphate (β-TCP) and sodium lauryl sulfate (SLS) was prepared using a mechanochemical process, examined using particle size analysis, IR spectroscopy, 31P, 23Na, and 13C solid-state NMR spectroscopy, and calcium dissolution experiments, and probed for in vitro remineralization of subsurface enamel lesions. Our results suggest that while the 31P environments of β-TCP remain unchanged during solid-state processing, there is noticeable shifting among the SLS 23Na and 13C environments. Therefore, given the structure of β-TCP, along with our IR examinations and calcium dissolution isotherms, SLS appears to interface strongly with the cation deficient C3 symmetry site of the β-TCP hexagonal crystal lattice with probable emphasis placed on the underbonded CaO3 polyhedra. To demonstrate the utility of the surface-active TCP material in dental applications, we combined the TCP-SLS with 5,000 ppm F (NaF) and evaluated the remineralization potential of subsurface enamel lesions via an in vitro remineralization/demineralization pH cycling dental model. Using surface and longitudinal microhardness measurements, the TCP-SLS plus 5,000 ppm F system was found to significantly boost remineralization of subsurface enamel lesions, with microhardness values increasing up to 30% greater than fluoride alone. © 2010 Springer Science+Business Media, LLC.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase II | Award Amount: 488.43K | Year: 2011

DESCRIPTION (provided by applicant): Recently, the Centers for Disease Control and Prevention publicized findings from the largest US study performed on dental health in 25 years indicating that while oral health is improving for most Americans, tooth decay among preschool children (between the ages of 2 and 5 years old) increased from 24% (between 1988-1994) to 28% (between 1999-2004). Of the types of oral formulations, mouthrinses are especially appealin not only because of simplicity and conveniencebut also for high-risk caries groups including those with orthodontic brackets and retainers, prostheses and restorations, dental erosion, children with developing permanent dentition, and those experiencing hyposalivation caused by medications and/or cancer treatments. Published studies reveal that multi-mineral treatments, including fluoride, calcium, and phosphorous can act synergistically to provide enhanced levels for protection compared to single mineral treatments. However, a major problem facing multi-mineral formulations, however, is that bioavailable fluoride and calcium cannot coexist in a single stable formulation for long periods of time, which ultimately reduces the shelf-life and therapeutic performance of the multi-mineral formulation. Because of the sensitivity of fluoride, currently there is no single-compartment multi-mineral mouthrinse available commercially in the US. Indiana Nanotech has patent- pending technology that functionalizes 2-tricalcium phosphate (TCP) with sodium lauryl sulfate (SLS) to create TCP-SLS hybrid materials that are compatible with fluoride. Importantly, when combined in an established and commercially available OTC fluoride mouthrinse formulation, TCP-SLS boosted enamel fluoride uptake (~ 25%) and strengthened enamel 'white-spots' (~ 50%) relative to the commercial OTC fluoride mouthrinse. The long-term goal of this research is to commercialize an economical OTC multi-mineral mouthrinse formulation that provides increased dental health benefits than would otherwisebe observed with fluoride alone. As part of our development and commercialization activities, we have developed this Phase II research proposal to the NIDCR that addresses the following Specific Aims: 1) Evaluation of stability and in vitro efficacy of NaFmouthrinse formulations containing TCP-SLS. These activities include FDA- recommended laboratory studies, including fluoride bioavailability, enamel fluoride uptake, and white-spot lesion reversal via remin/demin cycling; 2) understand the remineralization effect of TCP-SLS. This will include extending our current understanding of TCP-SLS by probing the bonding and interface characteristics of TCP-SLS, as well the enamel tissue that is treated with TCP-SLS and fluoride; and 3) Evaluation of the most promising prototype mouthrinse formulation against a commercially available fluoride mouthrinse rinse in a placebo-controlled double-blind cross-over in situ clinical study. PUBLIC HEALTH RELEVANCE: Recently, the Centers for Disease Control and Preventionpublicized findings from the largest US study performed on dental health in 25 years indicating that while oral health is improving for most Americans, tooth decay among preschool children (between the ages of 2 and 5 years old) increased from 24% (between 1988-1994) to 28% (between 1999-2004). Of the types of oral formulations, mouthrinses are especially appealing not only because of simplicity and convenience but also for high-risk caries groups including those with orthodontic brackets and retainers, prostheses and restorations, dental erosion, children with developing permanent dentition, and those experiencing hyposalivation caused by medications and/or cancer treatments. However, a major problem facing multi-mineral formulations, however, is that bioavailable fluoride and calcium cannot coexist in a single stable formulation for long periods of time, which ultimately reduces the shelf-life and therapeutic performance of the multi-mineral formulation. Therefore, developing a daily-use mouthrinse formulation comprising calcium minerals that function synergistically with fluoride to provide greater anticaries performance relative fluoride alone may provide a significant public health benefit.


Mackey A.,Indiana Nanotech, Llc | Karlinsey R.L.,Indiana Nanotech, Llc | Chern A.,Indiana University | Chu T.G.,Indiana University
International Journal of Medical Engineering and Informatics | Year: 2010

Metal oxides have been explored as potential surgical implant coatings designed to incorporate the biocompatibility of the surface oxide with the durable mechanical properties of the underlying metal. A novel anodisation process has been designed which generates an oxide composed of crystalline Nb2O5 microcones interspersed in an amorphous interface oxide. Thin sheets of niobium metal were anodised in a HF(aq) electrolyte for 1, 2 and 4 hrs. Scanning electron microscopy (SEM) was used to analyse the oxide features for each anodisation time. Larger and fewer microcones resulted from increased anodisation time. Due to the requirement of surgical implants to be autoclaved before implantation, the microcone features were analysed using SEM before and after autoclaving. Statistical analysis showed that the microcone features changed very little after autoclaving. MC3T3-E1 pre-osteoblast cells cultured on the autoclaved discs indicated that the 1 h and 4 h groups support the highest amount of cell proliferation. © 2010 Inderscience Enterprises Ltd.


PubMed | Indiana Nanotech, Llc
Type: Journal Article | Journal: Advances in dental research | Year: 2012

With more than 50 years of clinical success, fluoride serves as the gold standard agent for preventing tooth decay. In particular, the action of fluoride facilitates saliva-driven remineralization of demineralized enamel and alters solubility beneficially. Still, tooth decay remains problematic, and one way to address it may be through the development of new mineralizing agents. Laboratory and clinical studies have demonstrated that the combination of fluoride and functionalized -tricalcium phosphate (fTCP) produces stronger, more acid-resistant mineral relative to fluoride, native -TCP, or fTCP alone. In contrast to other calcium-based approaches that seem to rely on high levels of calcium and phosphate to drive remineralization, fTCP is a low-dose system designed to fit within existing topical fluoride preparations. The functionalization of -TCP with organic and/or inorganic molecules provides a barrier that prevents premature fluoride-calcium interactions and aids in mineralization when applied via common preparations and procedures. While additional clinical studies are warranted, supplementing with fTCP to enhance fluoride-based nucleation activity, with subsequent remineralization driven by dietary and salivary calcium and phosphate, appears to be a promising approach.


PubMed | Indiana Nanotech, Llc
Type: | Journal: The open dentistry journal | Year: 2012

The purpose of this study was to evaluate the effects of two simulated saliva (SS) remineralization solutions comprising different calcium-inorganic phosphate (Ca/P(i)) ratios on eroded enamel.3 mm diameter enamel cores were extracted from bovine teeth, mounted in acrylic rods, ground and polished,and initially demineralized with either 0.3% (120 minutes) or 1.0% (30 minutes) citric acid solutions (pH 3.8). Both sets of initially eroded specimens were evaluated for surface microhardness (N=10) and treated with either 0.3 or 1.6 Ca/P(i) ratio SS. Groups were first exposed to a seven-day remineralization period and then were cycled in a three-day regimen consisting daily of three rounds of two-hour plus overnight SS treatments and three 10-minute static immersions in demineralization solution. Specimens were assessed using surface microhardness and scanning electron microscopy.Initial erosion from 0.3% citric acid led to elliptical-shaped pore openings several microns in length and in depth and contrasted significantly with respect to 1% citric acid. The greatest remineralization was observed from the 0.3 Ca/P(i) SS, while the 1.6 Ca/P(i) SS produced the least.This study demonstrated the nature of remineralization of eroded enamel depends on both initial erosive conditions and the Ca/P(i) ratio of simulated saliva.


PubMed | Indiana Nanotech, Llc
Type: Comparative Study | Journal: Journal of materials science. Materials in medicine | Year: 2010

A hybrid material comprised of beta-tricalcium phosphate (beta-TCP) and sodium lauryl sulfate (SLS) was prepared using a mechanochemical process, examined using particle size analysis, IR spectroscopy, (31)P, (23)Na, and (13)C solid-state NMR spectroscopy, and calcium dissolution experiments, and probed for in vitro remineralization of subsurface enamel lesions. Our results suggest that while the (31)P environments of beta-TCP remain unchanged during solid-state processing, there is noticeable shifting among the SLS (23)Na and (13)C environments. Therefore, given the structure of beta-TCP, along with our IR examinations and calcium dissolution isotherms, SLS appears to interface strongly with the cation deficient C(3) symmetry site of the beta-TCP hexagonal crystal lattice with probable emphasis placed on the underbonded CaO(3) polyhedra. To demonstrate the utility of the surface-active TCP material in dental applications, we combined the TCP-SLS with 5,000 ppm F (NaF) and evaluated the remineralization potential of subsurface enamel lesions via an in vitro remineralization/demineralization pH cycling dental model. Using surface and longitudinal microhardness measurements, the TCP-SLS plus 5,000 ppm F system was found to significantly boost remineralization of subsurface enamel lesions, with microhardness values increasing up to 30% greater than fluoride alone.

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