bluuebunny/crossref_metadata_2025_split huggingface dataset:
Principles of Evaluation of the Diagnostic Value of Subgingival Bacteria
Authors: Zambon Joseph J. 
Published: October 2010

AbstractThis paper describes steps in the process of evaluating subgingival bacteria assays for the diagnosis of periodontal disease. The first step examines the infectious etiology of periodontal disease in pointing to specific oral bacteria as periodontal pathogens. Second is characterization of the laboratory test to detect and quantitate these pathogens as to sensitivity, specificity, and positive and negative predictive value. Third is the role of the laboratory test in the diagnosis of the different forms of periodontal disease which is related to the current clinical rather than microbiological definition of these diseases. The fourth and most important step is an analysis of the significance of subgingival bacterial tests in clinical decision‐making. Ann Periodontol 1997;2:138–148.
Overview of Clinical Trials on Periodontal Regeneration
Authors: Caton Jack G. 
Published: October 2010

AbstractPeriodontal regeneration means healing after periodontal surgery that results in the restoration of the tooth‐supporting tissues; namely, cementum, alveolar bone, and periodontal ligament. The response of the periodontium to conventional periodontal flap surgery is primarily repair. Regenerative flap procedures involve modifications intended to alter variables in the normal wound healing response to shift the outcome from repair to regeneration. Technical manipulations, devices, pharmacological agents, and biologicals have been used to obtain regeneration. Evaluation of periodontal therapy is done by clinical and histological assessments. Human clinical trials depend on probing, re‐entry, and radiographic measurements which cannot distinguish between periodontal repair and regeneration. Histological studies are difficult in humans because they require the retrieval of tissue blocks containing the teeth and their surrounding tissues, and for this reason these studies have largely been done in animal models; however, the use of animal models creates problems of interpretation when applying the information to the human. There are other fundamental problems related to assessment of new methods of periodontal regeneration. Ideally, periodontal regeneration is attempted after resolving the periodontitis that produced the loss of periodontal support. Does the type of periodontal disease affect the outcome? If it does, then separate clinical trials would be indicated to manage defects produced by different diseases. Furthermore, certain types of periodontal defects apparently respond better than others (for example, intrabony defects versus suprabony defects). Does each type of defect require a separate trial? Do subjects respond differently and, if so, how should this be factored into selection of the study population and sample size? There appear to be more questions than answers concerning the design of clinical trials for periodontal regeneration. This is not surprising since regeneration has been possible for only a few years, is apparently unpredictable, and the origin and nature of the new tissue are poorly understood. These factors make it important that the design of clinical trials be openly and thoroughly discussed so that practical solutions are forthcoming. Ann Periodontol 1997;2:215–222.
Regulatory Issues Relating to Therapies for Periodontal Regeneration
Authors: Singleton D. Gregory , Torres‐Cabassa Angel 
Published: October 2010

AbstractThe Food and Drug Administration (FDA) has regulated medical devices since May 1976, when the Medical Device Amendments were enacted. The clinical trial requirements for the marketing of periodontal regeneration devices have been dependent, in part, on the degree of their similarity to devices marketed prior to the legislative enactment date in terms of materials, indication statements, and labeling claims. Nonresorbable barriers were allowed to be marketed based on their equivalence to devices marketed prior to the enactment date based on biocompatability and clinical trial data under the premarket notification requirements section of the law. Bone filling materials such as hydroxyapatite were first marketed based on the finding of equivalence to predicate devices. Newer technologies such as bioabsorbable barriers have also been reviewed under the premarket notification provisions of the law, but manufacturers have been required to provide more extensive safety and effectiveness data to establish equivalence to pre‐Amendments devices. Data to answer questions related to the potential toxicity of breakdown products, period of absorption, and ultimate clinical effectiveness needed to be answered prior to marketing. New devices that incorporate technologies that are not substantially equivalent to predicate devices must proceed through the premarket approval route to marketing. For new devices considered a potential significant risk to the patient population, clinical trials are conducted via the investigational device exemption (IDE) requirements that specify the means by which trials will proceed in order to protect the rights of patients. New devices of organic origin, such as bone morphogenic protein, have followed the premarket approval route with IDE requirements instituted as a condition for their path to the marketplace. Issues associated with immediate and long‐term contact including potential toxicity, tumorigenicity, and sensitization need to be addressed with appropriate animal models. Ann Periodontol 1997;2: 223–228.
Specific Issues in Clinical Trials on the Use of Barrier Membranes in Periodontal Regeneration
Authors: Garrett Steven 
Published: October 2010

AbstractThere are presently a number of different barriers available for use clinically in guided tissue regeneration (GTR) procedures. A number of trials using these techniques and comparing different types of barrier membranes are being published in the scientific literature. This review discusses issues related to clinical trials on the use of barrier membranes in periodontal regeneration. Outcome measures, both clinical and histological, are discussed in relation to results following GTR procedures. The difference between regeneration and repair is reviewed as well as methods of clinical and histologic assessment of both these outcomes. Data regarding the impact of patient variables and tooth or defect variables on outcomes are presented and suggestions for study designs are made based on these variables. Aspects of assessing for an appropriate sample size in superiority and equivalency trials using GTR techniques are presented as well as interpretation of results following these trials and their clinical significance. Ann Periodontol 1997;2:240–258.
Overview of Clinical Trials on Endosseous Implants
Authors: Fritz Michael E. 
Published: October 2010

AbstractEarly history of clinical trials on endosseous implants revolved around anecdotal reports on predominantly blade implants in the U.S. The first criteria to define success or failure were established at the National Institutes of Health (NIH)‐Harvard Conference in 1978. This was followed by the multi‐center trials from the Branemark group which described round, metallic implants. At the 1988 NIH Conference, questions dealt with the following: 1) the effectiveness of dental implants for the long‐term; 2) indications and contra‐indications of various types of implants; 3) requirements for management of dental implants; 4) health risks of dental implants; and 5) future directions in research. In the ensuing 7 years since the second NIH Conference, most of the data generated have been from non‐controlled case reports, which describe a 90% success rate in 5 years or more with many types of endosteal systems in both partially and fully edentulous patients. Therefore, it can be said that there is evidence that dental implants are effective for the long‐term. The other questions posed at the 1988 NIH Conference have not been as well described and have led to many controversies and future research areas. Two areas which will have a special future impact are 1) the establishment of a standard of care and risk‐benefit ratio for implants and 2) the use of various factors to accelerate bone formation to allow greater access to dental implants by patients. Ann Periodontol 1997;2: 270–283.
The Nature of Periodontal Diseases
Authors: Socransky Sigmund S. , Haffajee Anne D. 
Published: October 2010

AbstractPeriodontal diseases are infections. They have a number of properties in common with infections in other parts of the body, but have unique features resulting from the passage of the tooth through the soft tissue integument into the oral cavity. The tooth provides a solid, non‐shedding surface for the colonization of potentially pathogenic bacterial species as well as a wide range of hostcompatible species. Periodontal pathogens frequently colonize the periodontal area for prolonged periods of time prior to disease initiation. Disease is caused by a finite set of bacterial species leading to the development of multiple periodontal diseases. Disease occurs at individual periodontal sites and leaves an historical record of the damage to the periodontium in the form of periodontal attachment or bone loss. This feature provides difficulty in investigation since it is often unclear whether the infectious process is presently occurring or is a reflection of past destruction. Control of periodontal diseases is most effectively performed by eliminating or suppressing the organisms that cause them and establishing a host compatible microbiota. When tissue damage has been extensive, regenerative or replacement procedures should be instituted after the infection has been controlled. Ann Periodontol 1997;2:3–10.
Voluntary Programs: ADA Seal Program and International Implications
Authors: Meyer Daniel M. 
Published: October 2010

AbstractFor about 130 years the American Dental Association (ADA) has aided the profession and the public in selecting safe and effective dental products. Since 1930, dental products have been evaluated through the ADA Seal program. In accordance with the ADA's Bylaws, the Council on Scientific Affairs assesses information evaluating the safety, efficacy, appropriate use, and promotional claims of dental products. In doing so, the Council may award the ADA's Seal of Acceptance. In collaboration with interested parties, expert consultants, and Council members, the ADA produces guidelines suggesting appropriate methodologies and submission data to assist manufacturers in voluntarily earning the Seal of Acceptance. To dole, numerous professional and consumer products have been evaluated, and about 1,300 of these products bear the Association's Seal of Acceptance. When a product is awarded the Seal it means that adequate data have been submitted and reviewed and, based on available information, the product meets ADA guidelines of safety and effectiveness. Dental health care professionals and consumers who use products that have the Seal can be confident that a product's properties and performance are consistent with current professional standards and manufac turers' claims. The ADA Seal program serves to help dentists and manufacturers meet their ethical obligations to the public by promoting safe and effective health care products. Ann Periodontol 1997;2:31–41.
Clinical Trials on Placement of Implants in Existing Bone
Authors: Weber Hans‐Peter , Fiorellini Joseph P. , Jeffcoat Marjorie C. 
Published: October 2010

AbstractThe use of dental implants has become a predictable and frequently used treatment modality in partially and fully edentulous patients. In 1987, the United States Food and Drug Administration (FDA) classified dental implants as class III medical devices. In 1989, a proposed rule was published by the FDA calling for a Premarket Approval Application (PMA) for dental implants. A PMA requires the demonstration of safety and effectiveness through clinical trials. Although the effective date for Premarket Approvals and detailed information on study requirements have not been announced, many implant manufacturers have already initiated multi‐center clinical trials. Despite these initiatives, several aspects regarding appropriate study designs, outcome criteria, and success or failure analysis still need clarification. Trials should be designed to minimize bias and variability. The cornerstone of the experimental design is set by the study objective. It will determine which of many possible clinical trial parameters are essential to enable the presentation of data to a regulatory body on which basis the safety and effectiveness of a device can be judged. With the multiplicity of patient characteristics, implant types, supported prostheses, study designs, evaluation parameters, and statistical analyses, it is a difficult task to design an optimal trial. It is the purpose of this paper to propose designs and components for implant clinical trials with various objectives. Ann Periodontol 1997;2:315–328.
The Research Team, Calibration, and Quality Assurance in Clinical Trials in Periodontics
Authors: Polson Alan M. 
Published: October 2010

AbstractThe present report provides an overview of practical issues related to training, calibrating, and monitoring the individuals involved in conducting a clinical trial. These aspects are considered in relation to a theoretical multi‐center clinical trial designed to test the safety and efficacy of a new periodontal treatment. Many factors need to be controlled in order to reduce inherent variability and provide standardization across the study population and study centers in a large‐scale multi‐center clinical trial. Components incorporated to control these factors include identification and recruitment of study centers, pre‐study training and organization of the teams at the different research centers, quality assurance procedures and monitoring of the study for compliance with protocol and safety requirements, and management of databases. Details are given regarding the use of pre‐study survey questionnaires to assess research center capabilities, methods for training and calibrating examiners and therapists and methods for integrating these aspects prior to actual study commencement, and quality assurance after the study has begun. The review considers the critical practical details regarding all of these aspects of study organization and execution. Ann Periodontol 1997;2:75–82.
Randomized Clinical Trials in Periodontology: Ethical Considerations
Authors: Levine Robert J. , Dennison David K. 
Published: October 2010

AbstractEthical justification for starting a clinical trial requires at the outset an accurate statement of “no difference” regarding the two or more agents to be compared. This may be expressed as “theoretical equipoise” (no data to support the superiority of one of the agents) or, preferably, as “clinical equipoise” (there are insufficient data to resolve controversy among experts as to which is superior). This presents a problem when a placebo control is proposed, particularly when the outcome measure entails irreversible loss of function; preliminary data often suggest the superiority of the “active agent.” Informed consent should ordinarily include the fact that treatment assignments will be accomplished by a process of randomization and, in the case of double‐blind designs, that neither the subject nor the investigator will know the subject's treatment assignment until the end of the trial. In general, clinical trials should be monitored by data and safety monitoring boards that have access to unblinded data; they should be guided by stopping rules that should be agreed upon by all concerned before the trial is begun. Women and minorities must be included unless there is strong justification for their exclusion. Care must be taken to balance the competing objectives of validity (the results will be correct), generalizability (the results will be broadly applicable), and efficiency (the study will not be unduly expensive). Ann Periodontol 1997;2: 83–94.
Overview of Clinical Trials of Periodontal Diagnosis Methods and Devices
Authors: Mandel Irwin D. 
Published: October 2010

AbstractChanging views of the pathogenesis and progression of the periodontal diseases and new modalities for treatment have stimulated a plethora of physical, biochemical, microbiologic, and Immunologie diagnostic procedures, tests, and devices. Clinical trials address needs for: 1) screening tests and risk assessment for disease susceptibility; 2) identification of active and progressive disease sites; 3) making therapeutic decisions; 4) monitoring therapy; 5) establishing a maintenance schedule; and 6) prognosis assessment. Needs and priorities of general, specialty, and public health practitioners differ. Validation of tests proceeds in a hierarchy of study designs from cross sectional and case control studies to retrospective and prospective longitudinal multi‐center trials. For broad‐scale application, randomized controlled trials (and eventual meta‐analysis) will be required. Design issues are those common to all clinical trials in periodontics plus special considerations depending on type of test and its intended use. For diagnostic tests, recommended surrogate endpoints are attachment and alveolar bone levels – the traditional “gold standards.” Validation of diagnostic tests is best accomplished by generation of 2 × 2 contingency tables to calculate sensitivity and specificity, positive and negative predictive values, relative and absolute risks, and odds ratios. Each has a place – depending on the clinical situation and needs of the clinician. Ann Periodontol 1997;2:98–107.
Dental Plaque, Platelets, and Cardiovascular Diseases
Authors: Herzberg Mark C. , Meyer Maurice W. 
Published: October 2010

AbstractCardiovascular diseases, including atherosclerosis and myocardial ischemia, occur as a result of a complex set of genetic and environmental factors. During periodontitis, dental plaque microorganisms may disseminate through the blood to infect the vascular endothelium and contribute to the occurrence of atherosclerosis and risk of myocardial ischemia and infarction. Myocardial ischemia and infarction are often preceded by acute thromboembolic events. In an in vitro model of thrombosis, certain dental plaque bacteria induce platelets to aggregate. Aggregation of platelets is induced by the platelet aggregation‐associated protein [PAAP] expressed on plaque bacteria, including Streptococcus sanguis and Porphyromonas gingivalis. Intravenous infusion of S. sanguis into rabbits has been shown previously to cause changes in the electrocardiogram (ECG), heart rate, blood pressure, and cardiac contractility. These changes are consistent with the occurrence of myocardial infarction. The ECG changes are now shown to begin within 30 seconds after infusion of PAAP+ S. sanguis, followed by alterations in blood pressure and respiratory rate. These changes occurred intermittently over a 30‐minute period and changed within one heartbeat to a normal pattern and suddenly back to abnormal. Intermittent ECG abnormalities were seen in 13 of 15 rabbits, including left axis deviation, ST‐segment depression, preventricular contractions, alternans, and bigemnia. Dose‐dependent thrombocytopenia, accumulation of 111Indium‐labeled platelets in the lungs, and tachypnea also occurred. No changes occurred with the PAAP− strain. The data indicated that PAAP+ S. sanguis interacts with circulating platelets, inducing thromboemboli to cause the pulmonary and cardiac abnormalities. During periodontitis, therefore, PAAP+ S. sanguis and P. gingivalis bacteremia may contribute to the chance of acute thromboembolic events. Ann Periodontol 1998;3:151–160.
The Relationship Between Dental Disease and Cerebral Vascular Accident in Elderly United States Veterans
Authors: Loesche Walter J. , Schork Anthony , Terpenning Margaret S. , Chen Yin‐Miao , Kerr Connie , Dominguez B. Liza 
Published: October 2010

AbstractWe report here information obtained from a cross‐sectional study of 401 veterans, who were at least 60 years of age, which showed that several dental/oral conditions can be significantly associated with the diagnosis of a cerebral vascular accident (CVA), when included in a multivariate logistic regression model with and without many of the known risk factors for a CVA. The dental findings relative to the prevalence of dental caries and periodontal disease were not distinctly different between the subjects with and without a CVA in the bivariate analysis. A higher stimulated salivary flow was negatively associated with a CVA in the multivariate models. The plaque index and oral hygiene habits relating to brushing, flossing, and frequency of having teeth cleaned by a dentist/hygienist were significantly associated with a CVA in the bivariate analysis. Among these oral hygiene parameters, “needing help in brushing one's teeth” and the reported annual visit to the dentist/hygienist for teeth cleaning remained significant in the multivariate models involving the dependent‐living subjects. The need for help in brushing one's teeth could reflect the fact that many subjects had reduced manual dexterity as a result of the CVA and required this extra care. However, the finding that those dependent‐living individuals who reported that they did not have their teeth cleaned at least once a year were 4.76 times more likely to have had a CVA, suggests that a pattern of oral neglect might be associated with developing a CVA. The implications of this in terms of an intervention strategy for CVA warrants further consideration. However, caution is recommended because the data were obtained from a convenience sampling of older veterans and may not be generalizable to other populations. Ann Periodontol 1998;3:161–174.
Possible Explanations for the Tooth Loss and Cardiovascular Disease Relationship
Authors: Joshipura Kaumudi J. , Douglass Chester W. , Willett Walter C. 
Published: October 2010

AbstractSeveral studies have shown relationships between periodontal disease and cardiovascular disease (CVD). A few studies have also shown that tooth loss may be associated with increased risk of coronary heart disease and stroke. We have reviewed the relevant literature to assess possible explanations for the reported associations between tooth loss and CVD. In particular, we considered whether the reported association between tooth loss and CVD could be explained by antecedent periodontal disease, antecedent caries, the extraction process, dietary changes following tooth loss, or confounding or bias from other sources. Since access to care and attitudes to health care may influence the decision to extract teeth, as well as cardiovascular disease risk, one needs to be cautious about confounding from behaviorally related factors. Available evidence suggests that further studies are needed to rule out that confounding is a possible explanation for the tooth loss and CVD relationship, that prior periodontal disease may not completely explain the tooth loss–CVD relationship, and that the role of diet needs to be further explored. Ann Periodontol 1998;3:175–183.