Diffusion of Vanadium Ions in Artificial Saliva and Its Elimination from the Oral Cavity by Pharmacological Compounds Present in Mouthwashes.

In this study, diffusion coefficients of ammonium vanadate at tracer concentrations in artificial saliva with and without sodium fluoride, at different pH values, were measured using an experimental model based on the Taylor dispersion technique. Ternary mutual diffusion coefficients (D11, D22, D12, and D21) for four aqueous systems {NH4VO3 (component 1) + ß-cyclodextrin (ß-CD) (component 2),} {NH4VO3 (component 1) + ß-cyclodextrin (HP-ß-CD) (component 2)}, {NH4VO3 (component 1) + sodium dodecyl sulphate (SDS) (component 2)} and {NH4VO3 (component 1) + sodium hyaluronate (NaHy) (component 2)} at 25.00 °C were also measured by using the same technique. These data showed that diffusion of ammonium vanadate was strongly affected in all aqueous media studied. Furthermore, a significant coupled diffusion of this salt and ß-CD was observed through the non-zero values of the cross-diffusion coefficients, D12, allowing us to conclude that there is a strong interaction between these two components. This finding is very promising considering the removal, from the oral cavity, of vanadium resulting from tribocorrosion of Ti-6Al-4V prosthetic devices.

Effect of Cobalt and Chromium Ions on the Chlorhexidine Digluconate as Seen by Intermolecular Diffusion.

Metal ions such as cobalt (II) and chromium (III) might be present in the oral cavity, as a consequence of the corrosion of Co-Cr dental alloys. The diffusion of such metal ions into the organism, carried by saliva, can cause health problems as a consequence of their toxicity, enhanced by a cumulative effect in the body. The effect of the chlorhexidine digluconate, which is commonly used in mouthwash formulations, on the transport of these salts is evaluated in this paper by using the Taylor dispersion technique, which will allow an assessment of how the presence of chlorhexidine digluconate (either in aqueous solution or in a commercial formulation) may affect the diffusion of metal ions. The ternary mutual diffusion coefficients of metal ions (Co and Cr) in the presence of chlorhexidine digluconate, in an artificial saliva media, were measured. Significant coupled diffusion of CoCl2 (and CrCl3) and chlorhexidine digluconate is observed by analysis of the non-zero values of the cross-diffusion coefficients, D12 and D21. The observed interactions between metal ions and chlorhexidine digluconate suggest that the latter might be considered as an advantageous therapeutic agent, once they contribute to the reduction of the concentration of those ions inside the mouth.

Small peptide (P-15) bone substitute efficacy in a rabbit cancellous bone model.

P-15 is a synthetic 15-amino acid residue identical to the cell binding domain of type I collagen. P-15 can be adsorbed onto anorganic bovine bone mineral (ABM) and will enhance cell attachment and subsequent cell activation. Although ABM/P-15 has been studied as a bone graft substitute in the oral cavity, its use in orthopedic models has been limited. Thus, this study investigated the efficacy of ABM/P-15 treatment in a rabbit model of long bone cancellous healing. Defects were created in the distal femurs and proximal medial tibiae of rabbits and were filled with either ABMP/P-15 suspended in hydrogel, ABM alone suspended in hydrogel, hydrogel carrier alone, or no graft material. Rabbits were sacrificed at 1, 2, 4, or 8 weeks postsurgery, and the femurs and tibiae were harvested. Histomorphometric analyses indicated that defects treated with ABM/P-15 had significantly larger areas of new bone formation than the other three treatments at 2 and 8 weeks postsurgery. ABM/P-15 treated defects also had significantly more bone growth than defects left empty or filled with ABM alone at 4 weeks postsurgery. Furthermore, histological examination did not reveal acute inflammatory infiltrate cells in any of the treatment conditions. These results are consistent with the findings of ABM/P-15 use in human oral-maxillofacial studies and in large animal spine fusion models.

Safety and immunogenicity of a pentavalent vaccine compared with separate administration of licensed equivalent vaccines in US infants and toddlers and persistence of antibodies before a preschool booster dose: a randomized, clinical trial.

OBJECTIVE: Our goal was to compare the safety and immunogenicity of a combination vaccine (DTaP(5)-IPV-Hib; Pentacel) with that of its separately administered, US-licensed equivalent vaccines (diphtheria, tetanus, 5-component acellular pertussis vaccine [DTaP(5); Daptacel], inactivated poliovirus vaccine [IPV; IPOL], and Haemophilus influenzae type b [Hib] vaccine [ActHIB]), when administered to infants and toddlers concomitantly with other routinely recommended vaccines and to assess antibody persistence from the fourth dose in toddlers to the fifth (preschool) DTaP(5) dose. SUBJECTS AND METHODS: In this randomized, multicenter study, 1939 healthy infants were immunized at 2, 4, and 6 months of age with 1 of 3 lots of DTaP(5) coadministered with IPV and Hib vaccines or 1 lot of DTaP(5)-IPV-Hib combination vaccine. Subsequently, 849 of these study participants were given a fourth dose of DTaP(5) and Hib vaccines or a fourth dose of DTaP(5)-IPV-Hib at 1 to 16 months of age. Safety was monitored throughout the study, and blood specimens were obtained to assess antibody responses. RESULTS: DTaP(5)-IPV-Hib elicited similar or fewer solicited injection-site and systemic reactions as compared with the separate administration of US-licensed DTaP(5), IPV, and Hib vaccines. Seroresponse and seroprotection rates elicited by DTaP(5)-IPV-Hib were noninferior to US-licensed equivalent vaccines after the infant series and after the fourth dose. Children immunized with DTaP(5)-IPV-Hib had higher antibody geometric mean concentrations to pertussis toxoid and filamentous hemagglutinin; children immunized with the separate vaccines had higher responses to pertactin. Hib antibody responses to Hib polysaccharide were nearly identical in the DTaP(5)-IPV-Hib and separate-vaccine groups. Persistence of antibodies to the fifth (preschool) dose was also similar between groups. CONCLUSIONS: DTaP(5)-IPV-Hib combination vaccine was shown to be immunogenic and well tolerated. No clinically important differences in the safety or immunologic profiles were noted for DTaP(5)-IPV-Hib versus the separately administered, US-licensed equivalent vaccines. DTaP(5)-IPV-Hib is a suitable replacement for separately administered DTaP, IPV, and Hib vaccines.

Monitoring the safety of a smallpox vaccination program in the United States: report of the joint Smallpox Vaccine Safety Working Group of the advisory committee on immunization practices and the Armed Forces Epidemiological Board.

In December 2002, the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices and the Department of Defense Armed Forces Epidemiological Board formed a joint Smallpox Vaccine Safety Working Group (SVS WG) to provide independent safety oversight for smallpox vaccination safety-monitoring systems. From January 2003 through June 2004, the SVS WG reviewed individual and aggregate safety data on postvaccination adverse events. Serious adverse events were rare because of careful education, prevaccination screening, and strict attention to vaccination-site management. Recent vaccinees safely cared for high-risk patients, adhering to recommended site care. Human immunodeficiency virus-infected individuals without severe immunosuppression had uncomplicated vaccination reactions. Epidemiological studies supported a causal relationship between myocarditis and/or pericarditis and smallpox vaccination. Data supported neutrality regarding hypothesized causal associations between vaccination and dilated cardiomyopathy or ischemic cardiac disease. The SVS WG concurs with recommendations to defer from vaccination any person with >/=3 ischemic cardiac disease risk factors.

A process for sentinel case review to assess causal relationships between smallpox vaccination and adverse outcomes, 2003-2004.

The US Department of Defense requested that the Advisory Committee on Immunization Practices-Armed Forces Epidemiological Board joint Smallpox Vaccine Safety Working Group define the likelihood that smallpox vaccination played a causal role in the fatal illness of an Army reservist. Reported serious adverse events for which there was no a priori reason to discount the existence of a causal association with smallpox vaccine were reviewed to assess whether they were signals of constellations of vaccine-associated adverse events. A causal relationship between the immunization experience and the index patient's death was favored, but the implication of an individual vaccine was precluded. No new smallpox vaccine-associated clinical syndromes were identified. The data supported neutrality regarding the hypothesis that dilated cardiomyopathy was causally associated with smallpox vaccine-induced myocarditis. This review of sentinel cases augmented the ongoing safety review process and was transparent, but it shares limitations with other case-based causality-assessment methods.

Clinical evaluation of the combination of anorganic bovine-derived hydroxyapatite matrix/cell-binding peptide (P-15) in particulate and hydrogel form as a bone replacement graft material in human periodontal osseous defects: 6-month reentry controlled clinical study.

BACKGROUND: This prospective, randomized, controlled clinical trial study compared the clinical outcomes of the biomaterial anorganic bovine-derived hydroxyapatite matrix/cell-binding peptide (ABM/P-15) as a biocompatible hydrogel carrier consisting of carboxymethylcellulose and glycerol or in particulate form when used as a bone replacement graft in the treatment of human periodontal infrabony defects. METHODS: Nineteen patients with advanced chronic periodontitis were recruited. All patients had at least two non-adjacent intrabony osseous defects > or = 3 mm after completion of cause-related periodontal therapy. The surgical procedures included access flaps for root instrumentation and filling the defect with ABM/P-15 in hydrogel or particulate form. Reentry access flap surgery was performed at 6 months. Changes in soft and hard tissue outcome measurements between baseline and 6 months were evaluated in all defects. RESULTS: At 6 months, no significant differences between ABM/P-15 hydrogel and ABM/P-15 particulate were demonstrated for the amount of defect fill (3.10 +/- 0.85 mm [75.0%] versus 3.09 +/- 1.11 mm [73.7%], respectively) or defect resolution (85.8% versus 81.9%). Changes in soft tissue clinical outcomes did not show significant differences between the treatments. CONCLUSION: This trial failed to demonstrate superiority of the novel ABM/P-15 hydrogel therapeutic modality over the standard ABM/ P-15 particulate graft in the treatment of intrabony periodontal defects.

Behavioural interventions and abuse: secondary analysis of reinfection in minority women.

Sexually transmitted infection (STI), including AIDS disproportionately affects minority women with a history of physical or sexual abuse. The objective of this study was to evaluate the efficacy of gender- and culture-specific behavioural interventions and interactive STI counselling for high-risk minority women with a history of physical or sexual abuse over two years. African- and Mexican-American women with a non-viral STI were enrolled in a randomized trial. Follow-up screens and interviews occurred at six months and one and two years. The primary outcome was subsequent infection with chlamydia and/or gonorrhoea. Secondary analysis of primary outcomes was made by self-reported physical or sexual abuse. Logistic regression was utilized on an intention-to-treat basis. Baseline data from 853 women were included; the retention rate was 91%. Infection rates were higher in abused women in Year 1 (29% vs. 23.8%, P=0.12), Year 2 (23.4% vs.17.6%, P=0.03) and cumulatively (43.8% vs. 33.0%, P=0.003). Unadjusted association between abuse and reinfection was stronger for adolescents (<19 years) than adults in Year 1 (42.7% vs. 30.8%, P=0.03), Year 2 (32.7% vs. 22.0%, P=0.03) and cumulatively (59.4% vs. 43.3%, P=0.004). Corresponding rates for adults were Year 1 (17.8% vs. 17.0%, P=0.84), Year 2 (17.4% vs. 12.7%, P=0.23) and cumulatively (30.7% vs. 22.3%, P=0.08). Reinfection rates were further stratified by adolescence and substance use. Abused adolescents had consistently higher reinfection than non-abused adolescents and abused adults. In conclusion, risk-reduction interventions decreased infective episodes with chlamydia and/or gonorrhoea in the two-year study period for non-abused women. Abused women, particularly adolescents and substance users, had increased episodes in these study periods.

Delays in immunization have potentially serious health consequences.

When children are not administered vaccinations according to the recommended schedule, they not only fail to receive timely protection from preventable diseases at a time when they are most vulnerable, but also increase their risk of never fully completing the vaccination course. Both outcomes compromise a successful childhood immunization program. Although current data suggest that vaccination rates are near 95% for school-aged children in the US, the rate of timely vaccination is much lower. A number of large studies have found that the majority of children are not currently vaccinated on schedule. Moreover, immunization levels for 2- to 3-year-old children have reached a plateau. It is essential to recognize that low overall rates of the targeted diseases mask the persistent threat they pose if adherence to vaccination schedules declines. A delay in one vaccine will produce a domino effect if catch-up adjustments in scheduled visits are not implemented aggressively. Published reports have demonstrated that failure to adhere to scheduled booster immunizations, not just the initial inoculation, results in resurgence of disease. Children fall off the vaccination schedule for a variety of reasons. Although many studies suggest that inadequate availability to healthcare is not a major determinant of delayed immunization, it still factors into parental decisions. Parents should be reminded of available healthcare options. From the clinician's end, computerization of healthcare records should allow for the generation of reminders. It is vital for clinicians to be aware that there are few contraindications to vaccination. They should also be prepared to address parental concerns regarding the safety of vaccines and should not hesitate to use topical analgesics or distraction techniques to facilitate inoculation. With the anticipation of several novel vaccines being added to the childhood and adolescent immunization schedule in the future, pediatricians face new challenges to not only provide every vaccination, but to do so in a timely manner. A lack of willingness on the part of the parent, or, occasionally, on the part of the clinician, to have multiple vaccines administered to the child during a single visit has been shown to be a significant cause of delayed vaccination. Since combination vaccines reduce the number of shots that need to be administered, the use of combination vaccines may provide the best opportunity to simplify the immunization schedule, increasing adherence in the process. Improved adherence to established schedules may present a major opportunity to further protect children from disease.

Safety, tolerability and immunogenicity of VAQTA given concomitantly versus nonconcomitantly with other pediatric vaccines in healthy 12-month-old children.

BACKGROUND: The objective of this study is to assess whether hepatitis A vaccine is immunogenic and well tolerated when administered to 12-month-old children alone or concomitantly with other routinely administered pediatric vaccines. METHODS: Six hundred seventeen healthy 12-month-old children were randomized to receive dose 1 of hepatitis A vaccine given alone or concomitantly with measles-mumps-rubella vaccine and varicella vaccine and dose 2 of hepatitis A vaccine given alone or concomitantly with diphtheria-tetanus-acellular pertussis vaccine and optionally with oral or inactivated poliovirus vaccine. Participants were followed for clinical adverse experiences and serologic responses to all vaccine antigens. Antibody responses were compared with historical controls for some indices. RESULTS: The safety profile was generally comparable whether hepatitis A vaccine was administered alone or concomitantly with other vaccines. When administered alone, the hepatitis A seropositivity rate was 98.3% and 100% for dose 1 and dose 2, respectively, and after dose 2 was similar to historical rates and the geometric mean titers were similar between initially seropositive and initially seronegative subjects (6207 and 6810 mIU/mL, respectively). After concomitant administration with hepatitis A vaccine, antibody responses to measles, mumps, rubella, diphtheria, tetanus and filamentous hemagglutinin (98.8%, 99.6%, 100%, 98.6%, 100% and 83.3%, respectively) were similar to historical controls and response to poliovirus was demonstrated, but immune responses to varicella zoster virus (79%) and pertussis toxoid (76%) were inferior to historical controls. CONCLUSIONS: Hepatitis A vaccine is highly immunogenic and generally well tolerated when administered to healthy children as young as 12 months of age regardless of initial hepatitis A serostatus and can be administered concomitantly with measles-mumps-rubella vaccine and oral or inactivated poliovirus vaccine.

Best-practice models that work: the CDC's Racial and Ethnic Adult Disparities Immunization Initiative (READII) Programs.

In this panel discussion, three health leaders provide information on techniques and approaches used to effectively implement the CDC's Racial and Ethnic Adult Disparities Immunization Initiative (READII) Programs. Part 1 offers an overview of READII and information on early results and program accomplishments. In Part 2, the Mississippi READII initiative is explored, with insights on how this program has served 10,000 African Americans in inner-city Jackson, Mississippi as well 23,000 elderly African Americans in 18 rural Delta counties, said to be the poorest counties in the nation. The third segment of this presentation explains challenges and successes found in San Antonio, Texas where READII efforts focused on immunizing the city's elderly Hispanics. Readers will find lessons learned and plans for future expansion to use as models when considering implementation of immunization programs in local communities.

Overcoming the hurdles to providing urban health care in the 21st century.

The delivery of health care services to urban populations in the United States is a system of rapidly increasing complexity. With the emergence of superspecialized physicians, a scientific approach to disease management has received great emphasis. Those providing health care at the population level may also apply this evidence-based approach. Analysis of the process of health care delivery in its entirety is complicated, confusing, and may be fraught with bias. In this article, a powerful instrument for providing a scientific approach to urban health care health policy development is introduced. This tool allows for analysis and assessment of hurdles to health care delivery to urban populations by dividing the process into elements of "administration," "provision," and "utilization" (APU). This APU triangle model, while intuitive, also allows a more definitive analysis by parts than would be possible to make of the whole. Using this model, the authors explore some of the hurdles faced by each element as well as some potential solutions. Although this model is presented in the context of urban hurdles to health care, it is equally applicable to rural environments or other service-delivery systems. In conclusion, this article discusses the emergence of the role of the public health department as the facilitator and manager between sectors of the community not traditionally connected in a collaborative health care model. Thus, the urban public health department coordinates efforts to surmount the hurdles and provides the venue for analysis, development, and employment of successful strategies.

Prevention of gonorrhea and Chlamydia through behavioral intervention: results of a two-year controlled randomized trial in minority women.

BACKGROUND: Sexually transmitted disease (STD), including AIDS, disproportionately affects African-American and Hispanic women. GOAL: To evaluate efficacy of standard and enhanced (addition of optional support groups) gender- and culture-specific, small-group behavioral interventions, compared to interactive STD counseling, in high risk minority women for two years. METHODS: Women with a non-viral STD were treated and enrolled in a randomized trial. Follow-up screens and interviews occurred at 6 months, 1 year, 18 months (short interview, optional exam) and 2 years. The primary outcome was subsequent infection with chlamydia and/or gonorrhea. Secondary outcomes included risky sexual behaviors. We employed logistic regression based on intention-to-treat. RESULTS: Data from 775 women were included; the retention rate was 91%. Adjusted infection rates were higher in the controls in Year 1 (26.8%), Year 2 (23.1%), and cumulatively (39.8%) than in the enhanced (15.4%, P = 0.004; 14.8%, P < 0.03; 23.7%, P < 0.001, respectively) and standard (15.7%, P = 0.006; 14.7%, P = 0.03; 26.2%, P < 0.008, respectively) intervention arms at these time points. Enhanced-intervention women who opted to attend support groups (attendees) had the lowest adjusted infection rates in Year 1 (12.0%) and cumulatively (21.8%). Intervention women in general, but particularly attendees, were significantly less likely than controls to have repeat infections. Multiple partners and unprotected sex with an untreated or incompletely treated partner helped explain group differences in infection. CONCLUSIONS: Risk-reduction interventions significantly decreased both single and multiple infective episodes with chlamydia and/or gonorrhea and risky sexual behaviors in the two-year study period. Support-group attendance appeared to contribute additional risk reduction in Year 1.

Strengthening the supply of routinely recommended vaccines in the United States: recommendations from the National Vaccine Advisory Committee.

Between late 2000 and the spring of 2003, the United States experienced shortages of vaccines against 8 of 11 preventable diseases in children. In response, the Department of Health and Human Services requested that the National Vaccine Advisory Committee (NVAC) make recommendations on strengthening the supply of routinely recommended vaccines. The NVAC appointed a Working Group to identify potential causes of vaccine supply shortages, develop strategies to alleviate or prevent shortages, and enlist stakeholders to consider the applicability and feasibility of these strategies. The NVAC concluded that supply disruptions are likely to continue to occur. Strategies to be implemented in the immediate future include expansion of vaccine stockpiles, increased support for regulatory agencies, maintenance and strengthening of liability protections, improved communication among stakeholders, increased availability of public information, and a campaign to emphasize the benefits of vaccination. Strategies requiring further study include evaluation of appropriate financial incentives to manufacturers and streamlining the regulatory process without compromising safety or efficacy.

Post-licensure comparative study of unusual high-pitched crying and prolonged crying following COMVAX and placebo versus PedvaxHIB and RECOMBIVAX HB in healthy infants.

BACKGROUND: In a previous clinical trial comparing COMVAX with its monovalent components, PedvaxHIB and RECOMBIVAX HB, one of 92 comparisons of post-vaccination adverse experiences revealed a higher rate of unusual, high-pitched crying following the second, but not the first or third doses of COMVAX compared with two monovalent control vaccines. Rates of prolonged crying were similar between groups at each visit. OBJECTIVES: To compare the frequencies of unusual, high-pitched crying between recipients of COMVAX plus placebo and recipients of PedvaxHIB plus RECOMBIVAX HB following the second vaccine doses (primary) and to summarize the frequency of unusual, high-pitched crying and prolonged crying after each vaccination visit. DESIGN: We enrolled 1215 healthy infants in a randomized, double blind, placebo-controlled study. Participating infants received study vaccines at 2 and 4 months of age and other routine childhood vaccines at 6-7 weeks and 3 months of age. Crying was evaluated via questionnaire at the time of enrollment (baseline) and daily from days 0 to 2 after each injection. RESULTS: Reports of unusual, high-pitched crying and prolonged crying were uncommon (<1%) prior to the first vaccination visit and were comparable in both treatment groups. After each injection, rates of unusual, high-pitched crying (range: 4.26-6.96%) and prolonged crying (range: 0-1.36%) appeared similar between treatment groups and for each vaccination visit. Crying resolved in all infants; no neurological impairment was reported. CONCLUSION: This study found no statistically significant differences in rates of unusual, high-pitched crying and prolonged crying in infants vaccinated with COMVAX plus placebo compared with infants vaccinated with its monovalent components, PedvaxHIB and RECOMBIVAX HB.

Immigrant health: legal tools/legal barriers.

The United States is a country of immigrants, our government having been formed by recent arrivals. This trend has continued throughout our history; according to the Center for Immigration Studies, more than 26 million immigrants have settled in the United States since 1970, and approximately one million new immigrants come to the United States each year. The immigrant population faces highly diverse health issues that states, cities, and counties must address, many of which pose significant legal and policy issues. Social, cultural, and linguistic factors complicate those challenges, as does the overlay of federal immigration and health policy. Two federal laws, the Welfare Reform Act of 1996 and Title VI of the federal Civil Rights Act of 1964, have affected immigrants in two very different ways. The former made it difficult for immigrants to qualify for publicly funded benefits. In contrast, Title VI made it easier for immigrants to obtain benefits by requiring federally funded service providers to offer translating services to persons with limited English language skills. Tuberculosis treatment is perhaps the most pressing health need among recent arrivals to the United States. Methods to slow down and hopefully eliminate this disease are underway, but a more comprehensive approach to not only tuberculosis but to immigrant health in general is needed. Indeed, it will benefit those directly affected by tuberculosis and will have serious implications for the entire population for generations to come.