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With decades of pre-clinical studies culminating in the recent clinical application of xenotransplantation, it would appear timely to provide recommendations for operationalizing oversight of xenotransplantation clinical trials. Ethical issues with clinical xenotransplantation have been described for decades, largely centering on animal welfare, the risks posed to the recipient, and public health risks posed by potential spread of xenozoonosis. Much less attention has been given to considerations relating to potentially elevated risks faced by those who may care for or otherwise have close contact with xenograft recipients. This paper examines the ethical and logistical issues raised by the potential exposure to xenozoonotic disease faced by close contacts of xenotransplant recipients-defined herein as including but not limited to caregivers, household contacts, and sexual partners-which warrants special attention given their increased risk of exposure to infection compared to the general public. We discuss implications of assent or consent by these close contacts to potentially undergo, along with the recipient, procedures for infection screening and possible quarantine. We then propose several options and recommendations for operationalizing oversight of xenotransplantation clinical trials that could account for and address close contacts' education on and agency regarding the risk of xenozoonosis., (© 2024 The Authors. Xenotransplantation published by John Wiley & Sons Ltd.)

Background: Xenotransplantation clinical trials may begin soon. A persistent risk of xenotransplantation, known for decades, is the possibility that a xenozoonotic infection could be transferred from a xenograft to its recipient and then to other human contacts. Because of this risk, guidelines and commentators have advocated for xenograft recipients to agree to either long-term or lifelong surveillance mechanisms., Methods: For the past few decades, one solution that has been proposed to ensure that xenograft recipients will comply with surveillance protocols is the use of a heavily modified Ulysses contract, which we review., Results: These contracts are most often used in psychiatry, and their application to xenotransplantation has been espoused several times with minimal criticism., Conclusions: In this article, we argue against the applicability of Ulysses contracts in xenotransplantation based upon (1) the telos of the advance directive that may not be applicable to this clinical context, (2) the suspect nature of enforcing Ulysses contracts in xenotransplantation, and (3) the ethical and regulatory hurdles that such enforcement would require. Although our focus is on the US regulatory landscape in preparation for clinical trials, there are applications globally., Competing Interests: The authors declare no funding or conflicts of interest., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Use of extracorporeal membrane oxygenation (ECMO) in cardiopulmonary resuscitation, termed eCPR, offers the prospect of improving survival with good neurological function after cardiac arrest. After death, ECMO can also be used for enhanced preservation of abdominal and thoracic organs, designated normothermic regional perfusion (NRP), before organ recovery for transplantation. To optimize resuscitation and transplantation outcomes, healthcare networks in Portugal and Italy have developed cardiac arrest protocols that integrate use of eCPR with NRP. Similar dissemination of eCPR and its integration with NRP in the USA raise novel ethical issues due to a non-nationalized health system and an opt-in framework for organ donation, as well as other legal and cultural factors. Nonetheless, eCPR investigations are ongoing, and both eCPR and NRP are selectively employed in clinical practice. This paper delineates the most pressing relevant ethical considerations and proposes recommendations for implementation of protocols that aim to promote public trust and reduce conflicts of interest. Transparent policies should rely on protocols that separate lifesaving from organ preservation considerations; robust, centralized eCPR data to inform equitable and evidence-based allocations; uniform practices concerning clinical decision-making and resource utilization; and partnership with community stakeholders, allowing patients to make decisions about emergency care that align with their values. Proactively addressing these ethical and logistical challenges could enable eCPR dissemination and integration with NRP protocols in the USA, with the potential to maximize lives saved through both improved resuscitation with good neurological outcomes and increased organ donation opportunities when resuscitation is unsuccessful or not in accordance with individuals' wishes., (© 2023. The Author(s).)

Background: The coronavirus disease 2019 pandemic has or threatens to overwhelm health care systems. Many institutions are developing ventilator triage policies., Objective: To characterize the development of ventilator triage policies and compare policy content., Design: Survey and mixed-methods content analysis., Setting: North American hospitals associated with members of the Association of Bioethics Program Directors., Participants: Program directors., Measurements: Characteristics of institutions and policies, including triage criteria and triage committee membership., Results: Sixty-seven program directors responded (response rate, 91.8%); 36 (53.7%) hospitals did not yet have a policy, and 7 (10.4%) hospitals' policies could not be shared. The 29 institutions providing policies were relatively evenly distributed among the 4 U.S. geographic regions (range, 5 to 9 policies per region). Among the 26 unique policies analyzed, 3 (11.3%) were produced by state health departments. The most frequently cited triage criteria were benefit (25 policies [96.2%]), need (14 [53.8%]), age (13 [50.0%]), conservation of resources (10 [38.5%]), and lottery (9 [34.6%]). Twenty-one (80.8%) policies use scoring systems, and 20 of these (95.2%) use a version of the Sequential Organ Failure Assessment score. Among the policies that specify the triage team's composition (23 [88.5%]), all require or recommend a physician member, 20 (87.0%) a nurse, 16 (69.6%) an ethicist, 8 (34.8%) a chaplain, and 8 (34.8%) a respiratory therapist. Thirteen (50.0% of all policies) require or recommend that those making triage decisions not be involved in direct patient care, but only 2 (7.7%) require that their decisions be blinded to ethically irrelevant considerations., Limitation: The results may not be generalizable to institutions without academic bioethics programs., Conclusion: Over one half of respondents did not have ventilator triage policies. Policies have substantial heterogeneity, and many omit guidance on fair implementation., Primary Funding Source: None.

Sumoylation (a covalent modification by Small Ubiquitin-like Modifiers or SUMO proteins) has been implicated in the regulation of various cellular events including cell cycle progression. We have recently identified CDK1, a master regulator of mitosis and meiosis, as a SUMO target both in vivo and in vitro, supporting growing evidence concerning a close cross talk between sumoylation and phosphorylation during cell cycle progression. However, any data regarding the effect of sumoylation upon CDK1 activity have been missing. In this study, we performed a series of in vitro experiments to inhibit sumoylation by three different means (ginkgolic acid, physiological levels of oxidative stress, and using an siRNA approach) and assessed the changes in CDK1 activity using specific antibodies and a kinase assay. We have also tested for an interaction between SUMO and active and/or inactive CDK1 isoforms in addition to having assessed the status of CDK1-interacting sumoylated proteins upon inhibition of sumoylation. Our data suggest that inhibition of sumoylation increases the activity of CDK1 probably through changes in sumoylated status and/or the ability of specific proteins to bind CDK1 and inhibit its activity., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Response to endotoxins is an important part of the organismal reaction to Gram-negative bacteria and plays a critical role in sepsis and septic shock, as well as other conditions such as metabolic endotoxemia. Humans are generally more sensitive to endotoxins when compared with experimental animals such as mice. Inflammatory caspases mediate endotoxin-induced IL-1β secretion and lethality in mice, and caspase-4 is an inflammatory caspase that is found in the human, and not mouse, genome. To test whether caspase-4 is involved in endotoxin sensitivity, we developed a transgenic mouse expressing human caspase-4 in its genomic context. Caspase-4 transgenic mice exhibited significantly higher endotoxin sensitivity, as measured by enhanced cytokine secretion and lethality following LPS challenge. Using bone marrow-derived macrophages, we then observed that caspase-4 can support activation of caspase-1 and secretion of IL-1β and IL-18 in response to priming signals (LPS or Pam3CSK4) alone, without the need for second signals to stimulate the assembly of the inflammasome. These findings indicate that the regulation of caspase-1 activity by human caspase-4 could represent a unique mechanism in humans, as compared with laboratory rodents, and may partially explain the higher sensitivity to endotoxins observed in humans. Regulation of the expression, activation, or activity of caspase-4 therefore represents targets for systemic inflammatory response syndrome, sepsis, septic shock, and related disorders.

Background: Past studies in the continental US have demonstrated that students from rural areas and those who go into primary care are more likely to practice in rural areas than urban-born and specialty physicians., Methods: This study uses two separate data sets to examine whether medical students and young physicians in Hawai'i follow the same pattern. A retrospective study of graduates of the University of Hawai'i John A. Burns School of Medicine from 1993-2006 was performed examining the relationship between practice location and high school attended for those practicing in Hawai'i. In addition, a survey was conducted with the first, second and third year medical students examining their practice intentions as related to where they grew up. Both data sets were analyzed using Chi Squared tests to determine the significance of associations between individuals from rural backgrounds practicing or intending to practice in rural areas., Results: The relationship in both cases showed that students and physicians from rural areas were more likely to practice in rural areas. However, 81% of all respondents reported being willing to consider practicing in rural area, especially if lifestyle, work environment, and employment opportunities were favorable., Discussion: If the State of Hawai'i wants to expand the physician workforce in the rural areas of Hawai'i, recruiting more students from rural areas and increasing desirability of rural practice settings are excellent paths to take.

Background: Research has shown that cultural competence training improves the attitudes, knowledge, and skills of clinicians related to caring for diverse populations. Social Justice in medicine is the idea that healthcare workers promote fair treatment in healthcare so that disparities are eliminated. Providing students with the opportunity to explore social issues in health is the first step toward decreasing discrimination. This concept is required for institutional accreditation and widely publicized as improving health care delivery in our society., Methods: A literature review was performed searching for social justice training in medical curricula in North America., Results: Twenty-six articles were discovered addressing the topic or related to the concept of social justice or cultural humility. The concepts are in accordance with objectives supported by the Future of Medical Education in Canada Report (2010), the Carnegie Foundation Report (2010), and the LCME guidelines., Discussion: The authors have introduced into the elective curriculum of the John A. Burns School of Medicine a series of activities within a time span of four years to encourage medical students to further their knowledge and skills in social awareness and cultural competence as it relates to their future practice as physicians. At the completion of this adjunct curriculum, participants will earn the Dean's Certificate of Distinction in Social Justice, a novel program at the medical school. It is the hope of these efforts that medical students go beyond cultural competence and become fluent in the critical consciousness that will enable them to understand different health beliefs and practices, engage in meaningful discourse, perform collaborative problem-solving, conduct continuous self-reflection, and, as a result, deliver socially responsible, compassionate care to all members of society.

Objective: The objective of this 16-week, double-blind, randomized, switch-over design study was to compare the efficacy in reducing dentin hypersensitivity of a dentifrice containing 8.0% arginine, calcium carbonate, and 1450 ppm fluoride as sodium monofluorophosphate (Colgate Sensitive Pro-Relief [also marketed as elmex Sensitive Professional]) to a desensitizing dentifrice containing 8% strontium acetate and 1040 ppm fluoride as sodium fluoride (Sensodyne Rapid Relief) under relevant consumer usage conditions., Methods: Qualifying subjects from the San Francisco, CA, USA area, who presented two hypersensitive teeth with a tactile hypersensitivity score (Yeaple Probe) between 10 and 50 grams of force and an air blast hypersensitivity score of 2 or 3 (Schiff Cold Air Sensitivity Scale), participated in this two-phase double-blind study. Subjects were randomly assigned to one of two test groups. The first phase of the study consisted of twice-daily at-home brushing with the first assigned dentifrice for eight weeks. The second phase of the study consisted of switching product use to the second assigned dentifrice for a second eight-week period. Dentin hypersensitivity examinations, which comprised tactile and air blast hypersensitivity measures, as well as examinations of oral hard and soft tissues, were conducted at baseline, at the completion of the first study phase, and at two weeks and eight weeks of the second phase., Results: One-hundred and twenty-one subjects complied with the study protocol and completed the study. Study Phase I: Subjects who brushed twice daily for eight weeks with the arginine/calcium carbonate dentifrice experienced statistically significant improvements in mean tactile and air blast hypersensitivity scores (51.3% and 39.4%, respectively) relative to that experienced by subjects who brushed with the strontium acetate dentifrice. Study Phase II: Subjects who brushed with the arginine/calcium carbonate dentifrice for the first eight weeks of the study and then switched to brush with the strontium acetate dentifrice for the second eight weeks of the study, did not exhibit further improvements in mean tactile or mean air blast hypersensitivity scores after two and eight weeks of switch-over product use. However, subjects who brushed with the strontium acetate dentifrice for the first eight weeks of the study and then switched to brush with the arginine/calcium carbonate dentifrice exhibited statistically significant improvements in mean tactile and air blast hypersensitivity scores two weeks (35.2% and 29.9%, respectively) and eight weeks (40.3% and 35.3%, respectively) after product switch-over. Relative to the subjects who switched from twice-daily brushing with the arginine/calcium carbonate dentifrice to brush with the strontium acetate dentifrice, those who switched from brushing with the strontium acetate dentifrice to brush with the arginine/calcium carbonate dentifrice exhibited statistically significant improvements in mean tactile hypersensitivity scores (10.3%) and in mean air blast hypersensitivity scores (16.3%) eight weeks after product switch-over., Conclusion: Eight weeks of brushing with Colgate Sensitive Pro-Relief(elmex Sensitive Professional) provides significant reductions in mean dentin hypersensitivity relative to the identical use of Sensodyne Rapid Relief. Additionally, the dentin hypersensitivity reductions achieved by twice-daily brushing with Sensodyne Rapid Relief are significantly improved by switching to twice-daily brushing with Colgate Sensitive Pro-Relief (elmex Sensitive Professional) for two and eight weeks. Further, the dentin hypersensitivity reductions achieved by twice-daily brushing with Colgate Sensitive Pro-Relief (elmex Sensitive Professional) are not improved by switching to twice-daily brushing with Sensodyne Rapid Relief for two or eight weeks. Eight weeks' use of Colgate Sensitive Pro-Relief (elmex Sensitive Professional), after having used Sensodyne Rapid Relief for an initial eight-week time period, provides statistically significant improvements in dentin hypersensitivity relative to eight weeks' use of the Sensodyne Rapid Relief.

In Hawaii, health care is a commodity, not a human right: those who can afford it receive care, those who cannot often don't. As health workers and health professional students, we witness the consequences that public policies and budget considerations have on people, on patients, on the health of those that we are dedicated to assisting. Beginning with a case study, we examine the historical antecedents leading to the increasing migration of Micronesians to Hawaii, examine the special relation that (Compact of Free Association) citizens have with the United States, and seek to reframe the political discussion regarding their health care status in this state as a debate in which medical considerations, not political or economic ones, should be the primary voice., (Hawaii Medical Journal Copyright 2010.)

Purpose: To determine the efficacy of an in-office desensitizing paste containing 8% arginine and calcium carbonate relative to that of a commercially-available pumice prophylaxis paste in reducing dentin hypersensitivity instantly after a single application following a dental scaling procedure and to establish the duration of sensitivity relief over a period of 4 weeks and 12 weeks., Methods: This was a single-center, parallel group, double-blind, stratified clinical study conducted in San Francisco, California, USA. Qualifying adult male and female subjects who presented two hypersensitive teeth with a tactile hypersensitivity score (Yeaple Probe) between 10-50 grams of force and an air blast hypersensitivity score of 2 or 3 (Schiff Cold Air Sensitivity Scale) were stratified according to their baseline hypersensitivity scores and randomly assigned within strata to one of two treatment groups: (1) A Test Paste, a desensitizing paste containing 8% arginine and calcium carbonate (Colgate-Palmolive Co); and (2) A Control Paste, Nupro pumice prophylaxis paste (Dentsply Professional). Subjects received a professionally-administered scaling procedure, after which they were re-examined for tactile and air blast dentin hypersensitivity (Post-Scaling Examinations). The assigned pastes were then applied as the final step to the professional dental cleaning procedure. Tactile and air blast dentin hypersensitivity examinations were again performed immediately after paste application. Subjects were provided with a commercially-available non-desensitizing dentifrice containing 0.243% sodium fluoride (Crest Cavity Protection, Procter & Gamble Co.) and an adult soft-bristled toothbrush and were instructed to brush their teeth for 1 minute, twice daily at home using only the toothbrush and dentifrice provided, for the next 12 weeks. Subjects returned to the testing facility 4 and 12 weeks after the single application of Test or Control paste, having refrained from all oral hygiene procedures and chewing gum for 8 hours and from eating and drinking for 4 hours, prior to each follow-up visit. Assessments of tactile and air blast hypersensitivity, and examinations of oral soft and hard tissue were repeated at these 4- and 12-week examinations., Results: 68 subjects completed the 12-week study. No statistically significant differences from baseline scores were indicated at the Post-Scaling Examinations for either the Test Paste or Control Paste groups. Immediately following product application and 4 weeks after product application, subjects assigned to the Test Paste group exhibited statistically significant improvements from baseline with respect to baseline-adjusted mean air blast (44.1% and 45.9% respectively) and mean tactile hypersensitivity scores (156.2% and 170.3% respectively). At the same time points, subjects assigned to the Control Paste group exhibited statistically significant improvements from baseline with respect to baseline-adjusted mean air blast (15.1% and 8.9% respectively) and mean tactile hypersensitivity scores (43.1% and 8.3% respectively). Immediately following application of the assigned paste and 4 weeks later, the Test Paste group demonstrated statistically significant reductions in dentin hypersensitivity with respect to baseline-adjusted mean air blast (34.1% and 40.6% respectively) and mean tactile hypersensitivity scores (79.0% and 149.6% respectively), compared to the Control Paste group. No statistically significant differences were exhibited between paste groups at the Post-Scaling and 12-week examinations with respect to mean tactile and baseline-adjusted mean air blast hypersensitivity scores.

Objective: The primary objective of this examiner-blind, randomized clinical study was to compare the effect of a toothpaste containing 8.0% arginine, calcium carbonate, and 1450 ppm fluoride, as sodium monofluorophosphate (MFP), in providing instant relief of dentin hypersensitivity when delivered as a single direct topical application using a cotton swab applicator versus using a fingertip. A secondary objective was to evaluate the effect on dentin hypersensitivity of the dentifrice after seven days of twice-daily at-home brushing, subsequent to the single direct topical application performed at the beginning of the study., Methods: Qualifying subjects possessed two baseline-designated hypersensitive teeth with a tactile hypersensitivity score of 10 to 50 grams of force (Yeaple Probe), and an air blast hypersensitivity score of 2 or 3 (Schiff Cold Air Sensitivity Scale). In the first phase of the study, subjects topically self-applied the test product using a fingertip, a previously validated method, for one of the hypersensitive teeth (fingertip test teeth), and a cotton swab applicator for the second hypersensitive tooth (swab test teeth). In the second phase of the study, subjects brushed with the test dentifrice twice daily for seven days. Dentin hypersensitivity assessments, as well as examinations of oral hard and soft tissues, were conducted immediately after direct topical product application, and after the subsequent seven-day brushing period., Results: Eighty-four subjects complied with the study protocol and completed the study. Immediately after direct topical application, the fingertip test teeth and the swab test teeth exhibited statistically significant (p <0.05) improvements from baseline in mean tactile hypersensitivity scores (191.7% and 182.1%, respectively), and mean air blast hypersensitivity scores (58.1% and 56.3%, respectively). After the seven-day brushing period, the fingertip test teeth and the swab test teeth continued to exhibit statistically significant (p < 0.05) improvements from baseline in mean tactile hypersensitivity scores (191.7% and 190.5%, respectively) and mean air blast hypersensitivity scores (57.4% and 58.2%, respectively). No statistically significant (p > 0.05) differences were indicated between the fingertip test teeth and the swab test teeth with respect to mean tactile hypersensitivity scores or mean air blast hypersensitivity scores immediately after topical application (3.4% and 4.4%, respectively), or after seven days of twice-daily brushing with the product (0.41% and -1.90%, respectively)., Conclusion: The results of this examiner-blind clinical study support the conclusions that 1) both fingertip and cotton swab methods of application provide significant reductions in dentin hypersensitivity immediately after a single direct topical application of the 8.0% arginine-calcium carbonate dentifrice, 2) when topical application is followed by seven days of twice-daily brushing with the dentifrice, the sensitivity relief obtained instantly after topical application is maintained, and 3) after topical application and after seven days of brushing, neither method of topical application provided a level of control of dentin hypersensitivity that differed significantly from the other.

Objective: The objective of this double-blind clinical study, conducted in harmony with Volpe-Manhold design for studies of dental calculus, was to compare the efficacy of a dentifrice containing 0.3% triclosan/2.0% polyvinylmethyl ether/maleic acid (PVM/MA) copolymer/0.243% sodium fluoride in a 17% dual silica base (Colgate Total Advanced Toothpaste) to that of a commercially available dentifrice containing 0.243% sodium fluoride in a silica base (Crest Cavity Protection Toothpaste) with respect to the reduction of supragingival calculus formation., Methods: Adult male and female subjects from the San Francisco area were entered into the eight-week pre-test phase of the study. Subjects received an evaluation of oral soft and hard tissues and were given a complete oral prophylaxis. They were provided with a non-tartar control placebo dentifrice and a soft-bristled adult toothbrush, and were instructed to brush their teeth twice daily (morning and evening) for one minute. After eight weeks of using the placebo dentifrice, subjects were examined for baseline supragingival calculus formation using the Volpe-Manhold Calculus Index. Qualifying subjects were randomized into two treatment groups which were balanced for gender and baseline calculus scores. All subjects entered into the twelve-week test phase were given a complete oral prophylaxis, and were provided with their assigned dentifrice and a soft-bristled adult toothbrush for home use. Subjects were instructed to brush their teeth for one minute twice daily (in the morning and evening). Prior to each study visit, subjects refrained from brushing their teeth and eating and drinking for four hours., Results: Seventy-seven (77) subjects complied with the protocol and completed the study. At the twelve-week examination, the Test Dentifrice group presented a mean Volpe-Manhold Calculus Index score of 13.22 and the Control Dentifrice group presented a score of 20.29. After twelve weeks of product use, the Test Dentifrice group exhibited 34.8% less supragingival calculus formation than the Control Dentifrice group (statistically significant at p < 0.05)., Conclusion: The overall results of this double-blind clinical study support the conclusion that after twelve weeks' use of a dentifrice containing 0.3% triclosan/2.0% PVM/MA copolymer/0.243% sodium fluoride in a 17% dual silica base provides significantly greater control of supragingival calculus formation relative to that of a commercially available dentifrice containing 0.243% sodium fluoride in a silica base.

Aim: To compare the anticalculus efficacy of an experimental dentifrice (0.454% stabilized stannous fluoride/sodium hexametaphosphate) with a negative control., Methods and Materials: This was a randomized, examiner-blind, parallel group study. After a three-month run-in, qualifying subjects were randomized to the experimental or control dentifrice to use twice a day for six months. Volpe-Manhold Index (V-MI) and oral soft tissue examinations were conducted at baseline, three, and six months. Additional analyses were performed separately at three and six months on three subgroups categorized into high, medium, and low calculus-forming subjects., Results: Compared to the control group, the experimental dentifrice group had a mean calculus score statistically significantly lower at both three months (50%) and six months (55%) post-treatment (p<0.001). Compared to control scores, mean experimental dentifrice calculus scores at three and six months were statistically significantly lower at both points in time for high, medium, and low calculus forming sub-groups (p<0.001). Both products were generally well tolerated., Conclusion: The experimental dentifrice revealed significant anticalculus efficacy compared to the control regardless of levels of baseline calculus formation., Clinical Significance: The stannous fluoride/sodium hexametaphosphate dentifrice technology is an effective calculus inhibitor for home care.

Objective: This randomized, double-blind, controlled clinical trial investigated the anticalculus effect of a cetylpyridinium chloride/ zinc gluconate (CPC/ZG) mucoadhesive gel., Methodology: The 80 adults from the San Francisco area who fulfilled the enrollment criteria were stratified based on total Volpe-Manhold Index (VMI) scores (low, medium, or high), gender, and other demographic data. Within these strata, they were randomly assigned to the CPC/ZG gel group or the placebo gel group, and underwent a baseline oral soft tissue (OST) examination. Subjects were dispensed Oral-B Indicator 35 Compact Head soft toothbrushes and Colgate Cavity Protection MFP toothpaste, and instructed to brush twice daily using these products. Every night for three months, following the nighttime brushing and just before retiring, subjects applied their assigned treatment gel to the lingual surfaces of the six mandibular anterior teeth. They were instructed not to eat or drink until morning and to avoid using other methods of interdental cleaning between the treated teeth, except to remove impacted food. Total VMI scores and OST examination findings obtained at three months were compared with baseline findings., Results: Seventy-eight (78) of the 80 subjects complied with the protocol and completed the study. After three months of treatment, the CPC/ZG group showed a 30% decrease in mean VMI score compared with a 0% decrease in the placebo group. OST examination at three months revealed no serious adverse events in either group., Conclusion: Results of this clinical trial indicate that regular use of the CPC/ZG gel, with or without the use of floss or other interdental cleaning products, yields a statistically significant reduction in calculus.

Purpose: Dentinal hypersensitivity is a common complaint among dental patients. Recently, a novel 0.454% stabilized stannous fluoride dentifrice containing sodium hexametaphosphate (SHMP) was introduced that offers a desensitizing benefit. This trial was conducted to assess the desensitizing efficacy of this new dentifrice relative to a sodium fluoride control dentifrice., Methods and Material: This was a double-blind, parallel-group, randomized clinical trial conducted according to the American Dental Association (ADA) Guidelines for the Acceptance of Products for the Treatment of Dentinal Hypersensitivity. Ninety subjects who met the entrance criteria were stratified based on age, gender, and baseline sensitivity scores and randomly assigned to either the stabilized stannous fluoride + SHMP dentifrice (Crest Pro-Health) or the sodium fluoride control dentifrice. Subjects were instructed to brush twice daily for eight weeks. Efficacy assessments were made, including tactile (Yeaple probe) and thermal (Schiff Air Index) sensitivity, and an oral soft tissue examination was conducted at baseline, week four, and week eight., Results: The mean sensitivity score based on the Schiff Air Index for the stannous fluoride + SHMP group was statistically significantly lower than that of the control group, at both weeks four and eight (P < .0001). At week eight, the stannous fluoride + SHMP dentifrice group had an adjusted mean 44% lower than that of the control group. The mean tactile sensitivity score for the stannous fluoride + SHMP group was statistically significantly higher, indicating a reduction in sensitivity, than that of the control group, at both weeks four and eight (P < .0001). At week eight, the stannous fluoride + SHMP dentifrice group had a mean desensitizing improvement of 71% greater than the control., Conclusion: The stabilized stannous fluoride + SHMP dentifrice provided statistically significant reductions in dentinal hypersensitivity at four and eight weeks compared to the sodium fluoride control dentifrice.

Objective: The objective of this examiner-blind clinical study was to investigate the efficacy of three oral hygiene regimens for the control of gingivitis and supragingival plaque., Methodology: Following a baseline examination for gingivitis and supragingival plaque, qualifying adult male and female subjects from the San Francisco, California area were stratified into three treatment groups, which were balanced for plaque. The groups were then randomly assigned to one of three oral hygiene regimens: 1) twice-daily tooth brushing with Colgate Total Toothpaste, accompanied by once-daily flossing after brushing; 2) twice-daily tooth brushing with Colgate Total Toothpaste without flossing; and 3) twice-daily tooth brushing with a sodium fluoride toothpaste, accompanied by once-daily flossing after brushing. All subjects were given a complete oral prophylaxis, and dispensed their assigned treatment product(s), along with a soft-bristled adult toothbrush for home use. All dentifrice products were supplied in the original packaging to which overwrapping had been applied. Subjects were instructed to brush their teeth for one minute twice daily (morning and evening) using only the dentifrice provided, and to refrain from using anything other than their assigned oral hygiene products for the duration of the study. In addition, subjects were instructed to refrain from any routine dental treatment (except emergency) during the course of the study. There were no restrictions regarding diet or smoking habits over the course of the study. Examinations for gingivitis and supragingival plaque, and oral soft tissue assessments were repeated after three months, and again after six months of product use., Results: One-hundred fourteen (114) subjects complied with the protocol and completed the six-month examinations. Statistical analyses showed similar results for both whole-mouth and interproximal scoring sites after six months of product use. Although not statistically significant, subjects using Colgate Total Toothpaste accompanied by the use of dental floss had numerically lower six-month scores for gingivitis and supragingival plaque formation when compared to the scores of subjects using Colgate Total Toothpaste without the use of dental floss. Relative to the sodium fluoride toothpaste accompanied by the use of dental floss, subjects using Colgate Total Toothpaste, both with and without the use of dental floss, exhibited statistically significant reductions in gingivitis and supragingival plaque formation after six months of product use., Conclusion: The results of this clinical study support the conclusion that the use of Colgate Total Toothpaste, both with and without the use of dental floss, provided statistically significant improvements over the sodium fluoride toothpaste plus flossing regimen with respect to the control of gingivitis and supragingival plaque formation. Although not statistically significant, numerically lower six-month scores for gingivitis and supragingival plaque were associated with Colgate Total Toothpaste accompanied by the use of dental floss, when compared with Colgate Total Toothpaste without the use of dental floss.

Stannous fluoride (0.4%) has been incorporated into oral hygiene products to reduce dentinal hypersensitivity since the 1960s. The present study was designed to assess the desensitizing efficacy of a stabilized 0.454% stannous fluoride/sodium hexametaphosphate dentifrice compared to a sodium fluoride control dentifrice. This was a double-blind, parallel-group, randomized clinical trial conducted according to the American Dental Association Guidelines for the Acceptance of Products for the Treatment of Dentinal Hypersensitivity. Seventy-seven subjects who met the entrance criteria were stratified based on age, gender, and air-sensitivity scores and randomly assigned to either the stabilized stannous fluoride/sodium hexametaphosphate dentifrice or the sodium fluoride control dentifrice. Subjects were instructed to brush twice daily for 8 weeks. Oral soft tissue examination and efficacy assessments including tactile (Yeaple probe) and thermal (Schiff Air Index) sensitivity were made at baseline, week 4, and week 8. The mean sensitivity score based on the Schiff Air Index for the experimental group was statistically significantly lower than that of the sodium fluoride control group, at both weeks 4 and 8 (P < .0001). The mean sensitivity score based on the Yeaple Probe Index for the stannous fluoride/sodium hexametaphosphate group was statistically significantly higher, indicating a reduction in sensitivity, than that of the sodium fluoride control group, at both weeks 4 and 8 (P < .0001). The results demonstrate that the stabilized stannous fluoride/sodium hexametaphosphate dentifrice provides clinically and statistically significant reductions in dentinal hypersensitivity when compared to the sodium fluoride control dentifrice.

The purpose of this study was to assess the anticalculus efficacy and long-term safety of a new stannous fluoride dentifrice containing sodium hexametaphosphate. This trial was a randomized, double-blind, parallel-group, 6-month study where, after a prophylaxis, subjects brushed twice daily with either a stabilized 0.454% stannous fluoride/13% sodium hexametaphosphate dentifrice (Crest Pro-Health) or a marketed multibenefit triclosan/copolymer control dentifrice. Study subjects were known to form supragingival calculus and had previously demonstrated the ability to form at least 1.5 mm using the Volpe-Manhold Calculus Index over a 2-month pretest period. Comparisons between treatments for anticalculus efficacy were performed using analysis of covariance. Eighty subjects were randomized into one of two treatment groups after stratification on gender and baseline calculus scores and then monitored for calculus formation, soft tissue tolerance, and extrinsic stain. The mean calculus score for the stannous fluoride/sodium hexametaphosphate group was statistically significantly lower than that of the triclosan/copolymer group at both months 3 and 6 (P < .01). At month 3, the stannous fluoride/sodium hexametaphosphate group had an adjusted mean 54% lower than that of the triclosan/copolymer group. At month 6, the stannous fluoride/sodium hexametaphosphate group had an adjusted mean 56% lower than that of the triclosan/copolymer group. Both dentifrices were well tolerated and neither dentifrice group developed appreciable extrinsic stain over the 6-month trial period. Overall, the stannous fluoride/sodium hexametaphosphate dentifrice had superior anticalculus efficacy relative to the marketed triclosan/copolymer control and a comparable soft tissue safety and extrinsic stain profile.

Twelve sets of FMS (full mouth survey) radiographs were taken by California licensed radiology technicians. Ten of the sets of FMS radiographs were taken using Ultra-Speed "D" film on the left side of the patient and Insight "F" speed film on the right side of the patient. The remaining two sets of films were taken using Insight Film on both sides of the patient to act as a control. Ten faculty members of the Diagnostic Department were asked to evaluate the twelve sets of FMS radiographs and report whether they had a preference for the right side, left side, or no preference. Criteria for preference were diagnostic ability and clarity of the films. The results of the study showed a preference for the right side (65.7%), which was imaged with Insight Film, compared to the left side (34.3%), which was imaged with Ultra-Speed Film.

Purpose: To evaluate the relative effectiveness provided by a new dentifrice containing 5.0% potassium nitrate and 0.454% stannous fluoride in a silica base (Colgate Sensitive Maximum Strength) for reducing dentin hypersensitivity over an 8-wk period, as compared to that provided by a commercially-available antihypersensitivity dentifrice containing 5.0% potassium nitrate and 0.76% sodium monofluorophosphate in a dicalcium phosphate base (Fresh Mint Sensodyne dentifrice)., Materials and Methods: To qualify for participation in this examiner-blind study, male and female adults from the San Francisco, California area were required to present with tactile and air blast dentin hypersensitivity in at least 2 non-molar teeth at two examinations, spaced 1 wk apart. Qualifying subjects were randomized into two treatment groups, which were balanced for gender, age, and baseline sensitivity scores. Subjects were provided with a soft-bristled toothbrush. Examinations for tactile and air blast sensitivity were repeated after 4 wks' use of the study dentifrices, and again after 8 wks' usage., Results: 101 subjects complied with the protocol, and completed the entire study. After 4 wks, subjects assigned to the Colgate Sensitive Maximum Strength group exhibited a statistically significant improvement over the Fresh Mint Sensodyne dentifrice group with respect to tactile sensitivity scores, and a statistically significant improvement over the Sensodyne dentifrice group with respect to air blast sensitivity scores. Correspondingly significant improvements were presented after 8 wks. Thus, the results of this examiner-blind clinical study support the conclusion that Colgate Sensitive Maximum Strength dentifrice provided superior levels of control of tactile and air blast sensitivity than did the clinically tested, commercially-available Sensodyne anti-hypersensitivity dentifrice.

The effect on dentinal hypersensitivity from the use of a new dentifrice containing 5.0% potassium nitrate and 0.454% stannous fluoride in a silica base (Colgate Sensitive Maximum Strength Toothpaste, Colgate-Palmolive Co.) over an 8-week period was compared to a commercially available dentifrice containing 5.0% potassium nitrate and 0.243% sodium fluoride in a silica base (positive control [Sensodyne Fresh Mint Toothpaste, Block Drug Company, Inc.]) and to a commercially available nondesensitizing dentifrice containing 0.243% sodium fluoride in a silica base (negative control [Colgate Winterfresh Gel, Colgate-Palmolive Co.]). A total of 120 participants were stratified into 3 balanced groups according to baseline mean air blast (thermal) and tactile (Yeaple Probe) sensitivity scores, gender, and age. Participants brushed their teeth twice daily (morning and evening) for 1 minute. Dentinal hypersensitivity examinations were conducted at baseline, 4 weeks, and 8 weeks by the same dental examiner. After 4- and 8-weeks' use of their assigned products, participants in the new dentifrice group demonstrated statistically significant improvements (p < 0.05) in tactile and air blast sensitivity, as compared to those using the positive and negative control dentifrices.

The effect on dentinal hypersensitivity from the use of a dentifrice containing 5.0% potassium nitrate, 1500 ppm sodium monofluorophosphate in a precipitated calcium carbonate (PCC) base over an eight-week period was compared to a placebo dentifrice without potassium nitrate. A total of forty-eight subjects were entered into the study and stratified into two balanced groups according to their baseline mean thermal (air blast) and tactile (Yeaple Probe) sensitivity scores. The two groups were randomly assigned to use either the potassium nitrate/PCC dentifrice or a placebo dentifrice without potassium nitrate. The two groups were well balanced with regard to their mean baseline thermal tactile sensitivity scores, sex and age. Subjects were instructed to brush their teeth twice daily (morning and evening) for one minute with their assigned dentifrice and a commercially available soft-bristled toothbrush. Dentinal hypersensitivity examinations, which included tactile and thermal sensitivity, were conducted at baseline, four weeks, and eight weeks. Examinations were conducted by the same dental examiner (TS) on the subjects at each examination. After four weeks' use of their assigned products, those subjects in the potassium nitrate/PCC dentifrice group demonstrated statistically significant improvements (p < 0.0001), as compared to the placebo dentifrice without potassium nitrate, in tactile and thermal sensitivity. After eight weeks' use of their assigned products, those subjects in the potassium nitrate/PCC dentifrice group again demonstrated statistically significant improvements (p < 0.0001), in tactile and thermal sensitivity, as compared to the placebo dentifrice without potassium nitrate. Thus it can be concluded from this study that the use of a dentifrice containing 5.0% potassium nitrate and 1500 ppm sodium monofluorophosphate in a precipitated calcium carbonate (PCC) base is a clinically effective method for reducing dentinal hypersensitivity.

The objective of this 3-month, double-blind study was to investigate the efficacy of Colgate Optimized Stannous Fluoride (COSF) dentifrice for the control of supragingival dental calculus accumulation. After 3 months' use, the COSF dentifrice group exhibited a statistically significant 56.6% reduction in supragingival calculus formation, as compared to the control dentifrice group. The results of this study support the conclusion that the COSF dentifrice is efficacious for controlling the accumulation of supragingival calculus.