bluuebunny/crossref_metadata_2025_split huggingface dataset:
Outcomes and Their Measurement in Clinical Trials of Endosseous Oral Implants
Authors: van Steenberghe D. 
Published: October 2010

AbstractThe clinical suitability of an oral implant system should be substantiated by wellplanned clinical trials that meet the expectations of both the patient and the clinician; i.e., to offer anchorage to a dental prosthesis for one or more decades. The literature often reports on the survival rather than on the success rate, and for the latter a large variety of more or less stringent criteria have been proposed. Although the use of cumulative percentages to assess survival or success on consecutive patients, the so‐called Kaplan‐Meier statistics, is essential, many publications only report on absolute percentages, thus giving much too optimistic results. Indeed, the large number of recently inserted implants tend to dilute the small fraction that has gone through the maximum observation period. Multi‐center studies on consecutive patients who are not selected on the basis of bone quality and. volume should be recommended. Otherwise the labeling of the implant should clearly mention which groups; e.g., smokers or patients with limited bone volume are not part of the validated target group. The final outcome measurement would be that an endosseous implant is no longer able to carry out its purpose: to anchor or support successfully a functional dental prosthesis. Like many other clinical evaluations, surrogate parameters have been sought to assess interim success rates. The stability of the marginal bone level is one parameter proposed by many, although bone loss as such is not synonymous with failure. Several implant systems with a roughened surface (plasma sprayed or coated) suffer from progressive marginal bone loss and consequently ongoing loss of implants even after 5 or more years. Those implant systems should be evaluated with cumulative success rates over a period of 10 years. Only those that demonstrated a clustering of both bone and implant loss during the first 1 or 2 years after insertion and subsequently a levelling off for those two parameters—a so‐called plateau pattern, should be allowed to draw conclusions after 5 years. Since radiographs reveal only the approximal areas, measurement of the attachment level by means of probing towards a reference point on the abutment should also be performed annually. Intra‐oral radiographs can only reveal absence of radiolucency at the bone‐implant interface, but do not prove osseointegration. The use of an electronic device offers objective results and reveals even subclinical mobilities of endosseous implants. One can conclude that there is an urgent need for a consensus between health authorities, third parties, and the scientific community to define a set of universally‐acceptable success criteria, to impose the use of cumulative success rates, and to ask for observation periods of 10 years for implants that do not demonstrate stable results after one or two years. Ann Periodontol 1997;2:291–298.
Clinical Trials on Implants in Regenerated Bone
Authors: Buser Daniel A. , Tonetti Maurizo 
Published: October 2010

AbstractThe lack of a sufficient volume of healthy jaw bone was the most important local contraindication for the placement of dental implants in the 1980s. Thus, several attempts have been made in the past 10 years to develop new surgical methods for the reconstruction of lost jaw bone in potential implant patients. At present, methods such as guided bone regeneration utilizing barrier membranes or sinus lift procedures are widely used in dental offices. There are, however, some concerns about the efficacy and predictability of these procedures. There is a need to determine how new bone regenerative procedures should be properly evaluated. The goal of the present paper is to establish some guidelines for clinical trials on implants in regenerated bone. It is proposed that such trials should be conducted in two main phases according to predetermined endpoints. The first main phase evaluates the new bone regenerative procedure. This almost always requires an initial development period including step‐by‐step modifications to identify essential surgical factors for the achievement of successful treatment outcomes. At the end, the surgical protocol will be established in detail. This is followed by the validation period to evaluate efficacy and predictability of this surgical protocol in a clinical study with consecutively treated patients. After successful bone regeneration has been properly documented, the second main phase evaluates the implants inserted in regenerated hone in a prospective clinical study utilizing the same protocol as for implants in pristine, non‐regenerated bone. This documentation allows the evaluation of tissue integration of these implants and their 5‐year success rates. Ann Periodontol 1997;2:329– 342.
Clinical Trials on Therapies for Peri‐Implant Infections
Authors: Lang Nikiaus P. , Mombelli Andrea , Tonetti Maurizio S. , Brägger Urs , Hämmerle Christoph H.F. 
Published: October 2010

AbstractPeri‐implant infections are pathological conditions which are normally localized in the soft tissues surrounding an oral implant. They may range from a rather localized mucositis lesion reflecting the host response to a bacterial challenge to a more advanced lesion “termed peri‐implantitis” when previously osseointegrated oral implants have been partially disintegrated; i.e. have lost alveolar bone around the implant. Usually these lesions start as a result of plaque accumulation and show similar progression as observed around teeth. Muscositis seems to be a prerequisite for the following peri‐implantitis. However, the factors involving the transition to a more advanced lesion are still not known. Logically, the therapy for peri‐implant infection has to be related to antibacterial treatment prior to the attempt to surgically regenerate peri‐implant alveolar bone lost as a result of the infection. In order to diagnose these lesions at an early stage frequent assessments of clinical parameters are needed during maintenance therapy. The anti‐infective treatment may intercept the development of the lesion. Following mechanical debridement of plaque deposits the application of efficacious antiseptics (Chlorhexidine) is a necessity. Following this, antibiotics may cumulatively be applied to control the infection. Only a few longitudinal studies have documented the efficacy of such treatment regimens, and controls have generally not been available for ethical reasons. In regenerating the lost jaw bone only case reports are available today. Controlled animal studies will have to be performed to document the possibility of re‐osseointegration and the factors influencing predictability. Ann Periodontol 1997;2:343–356.
Design Principles nand Statistical Considerations in Periodontal Clinical Trials
Authors: Koch Gary G. , Paquette David W. 
Published: October 2010

AbstractAlthough clinical trials are a small subset of conducted biomedical research, they have become powerful investigational tools for the evaluation and approval of new treatments by clinician groups and regulatory agencies like the US Food and Drug Administration. To impact the delivery of care, trials in general must meet three criteria: clarity, comparability, and generalizability. Accordingly, trials can offer meaningful data if they have procedures which are well defined and subjects who represent a reasonably homogeneous population. The evaluation of Periodontptis interventions presents several challenges due to the disease's heterogeneity and its irregular, episodic pattern; nevertheless, the intent of these novel interventions is to prevent, diagnose, inhibit, or reverse periodontal disease progression. Careful consideration of the trial's objectives should dictate clinical endpoints (primary and surrogate), comparison groups (placebo, standard therapy, test therapy), and equivalence versus superiority as the basis for conclusions. Several design elements such as control population specification, randomization, masking, sample size calculation, and standardization of procedures for patient care and assessment can decrease potential bias and variability. In both parallel and paired (split‐mouth) design trials, multiplicities of endpoints, treatments, and subgroups require strategies which address the broader scope of chance findings without excessive loss of study power. Also, the longitudinal assessment of multiple periodontal sites within patients produces correlated data structures for which analytic methods need to account for the appropriate sampling unit. With these design and analytic elements, clinical trials can provide important evidence to investigators, patients, and governmental agencies for the introduction of novel interventions in periodontal practice. Ann Periodontol 1997;2:42–63.
Subject Recruitment, Retention, and Compliance in Clinical Trials in Periodontics
Authors: Milgrom Peter M. , Hujoel Philippe P. , Weinstein Philip , Holborow Douglas W. 
Published: October 2010

AbstractRecruitment of subjects in randomized controlled trials is the process of screening and enrolling a predetermined number of subjects within a planned time. Differences between projected and actual recruitment rates are common and, when large, form a serious threat to the successful completion of the trial. Recruitment can be enhanced by 1) use of different, concurrent recruitment methods; 2) avoiding underestimations of the costs and time intensity of subject recruitment; and 3) regular monitoring of the efficiency of the recruitment effort. The recruitment process can be complicated by legal requirements of proper representation of sex and race characteristics or by stringent entry criteria. Complex designs (e.g., trials with a pre‐randomization placebo run‐in, split‐mouth designs) have not yet shown to be cost‐effective and may endanger recruitment success. Enhancing both subject retention and protocol compliance requires careful planning, attention to product design and staff training. The impact on trial findings is discussed. Ann Periodontol 1997;2:64–74.
Phagocytic Function of Salivary PMN After Smoking or Secondary Smoking
Authors: Numabe Yukihiro , Ogawa Tomohisa , Kamoi Hisahiro , Kiyonobu Kohichi , Sato Soh , Kamoi Kyuichi , Deguchi Shinji 
Published: October 2010

AbstractAlterations in polymorphonuclear leukocyte (PMN) functions, such as phagocytosis, Chemotaxis, and oxidative burst, play a pivotal role in periodontal pathogenesis. In addition, previous studies have demonstrated a strong relationship between smoking and periodontal disease. In the present study, the effect of cigarette smoking or passive smoking (secondary smoking) on the phagocytic function of salivary PMN (SPMN) was investigated. Twenty volunteers with clinically healthy gingiva (10 smokers, 10 non‐smokers) participated in this study. In a small room, the smokers and passive smokers (non‐smokers) were instructed to smoke and breathe, respectively, in an identical, specific way for about 4 minutes. SPMN was isolated immediately before and after smoking or passive smoking. PMN was then incubated with fluoresbrite beads for 45 minutes at 37°C and the phagocytic status estimated by using a flow cytometer. Cell viability was determined by trypan blue exclusion (smokers before smoking: 88.3%; smokers after smoking: 89.6%; non‐smokers before passive smoking: 89.0%; non‐smokers after passive smoking: 89.4%). In both smokers and passive smokers, the proportion of phagocytic cells increased between before and after smoking (smokers before: 33.2%; after: 42.1%; passive smokers before: 36.2%; after: 44.1%). Both increases were statistically significant (P < 0.01). These results demonstrate that the phagocytic activity of SPMN intensifies after smoking and passive smoking. They also suggest that certain substances in cigarette smoke, perhaps nicotine, overstimulate the host response in the oral cavity. Ann Periodontol 1998;3:102–107.
The Pathobiology of Periodontal Diseases May Affect Systemic Diseases: Inversion of a Paradigm
Authors: Page Roy C. 
Published: October 2010

AbstractA new paradigm for the pathobiology of periodontitis is presented, and the manner in which periodontitis may relate to susceptibility for certain systemic diseases such as cardiovascular disease and preterm labor is described. Periodontitis is caused by a small group of Gram‐negative bacteria present on the tooth root surfaces as biofilms. Lipopolysaccharide (LPS) and other substances gain access to the gingival tissues, initiate and perpetuate immunoinflammation, resulting in production of high levels of proinflammatory cytokines. These induce production of matrix metalloproteinases which destroy the connective tissues of the gingiva and periodontal ligament, and prostaglandins which mediate alveolar bone destruction. Periodontitis may enhance susceptibility to systemic diseases in several ways. LPS and viable Gram‐negative bacteria from the biofilms and proinflammatory cytokines from the inflamed periodontal tissues may enter the circulation in pathogenic quantities. In addition, periodontitis and certain systemic diseases, such as cardiovascular disease, share risk factors including tobacco smoking, male gender, race/ethnicity, stress, and aging. Ann Periodontol 1998;3:108–120.
Etiopathogenesis of Cardiovascular Disease: Hemostasis, Thrombosis, and Vascular Medicine
Authors: Lowe Gordon D.O. 
Published: October 2010

AbstractThe role of hemostatic variables (which promote hemostatic plugs and thrombi) and rheological variables (which affect blood flow) in the pathogenesis of vascular diseases (ischemic heart disease, stroke, and peripheral arterial disease) is reviewed, with emphasis on epidemiological studies. Rheological variables are consistently associated with both prevalent and incident cardiovascular disease. These associations are only partly explained by conventional risk factors. The predictive value of plasma viscosity for cardiovascular events is partly explained by fibrinogen, and partly by lipoproteins. The associations of whole blood viscosity with cardiovascular disease are partly explained by plasma viscosity and partly by hematocrit. White cell count, but not platelet count, predicts ischemic heart disease events. Cigarette smokers have higher levels of rheological variables than non‐smokers; these increases are partly or wholly reversible in ex‐smokers. Lipoprotein reduction by pravastatin lowers plasma and whole‐blood viscosity, which may be one mechanism through which lipid lowering produces an early reduction in cardiovascular events. Data from the Edinburgh Artery Study suggest that viscosity is related both to the extent of atherosclerosis, and to ischemia in the presence of a given degree of atherosclerotic stenoses. Among hemostatic variables, fibrinogen, factor VIII: vWF complex, tPA antigen, and fibrin D‐dimer are associated with both prevalent and incident cardiovascular disease. Again, these associations are only partly explained by conventional risk factors. They suggest that endothelial disturbance and increased fibrin turnover may play roles in cardiovascular disease. Hemostatic and rheological variables are therefore associated with both prevalent and incident cardiovascular disease, and may be mechanisms through which risk factors such as smoking, hyperlipidemia and infections (including oral infections) may promote vascular events. Ann Periodontol 1998;3:121–126.
Enhanced Interaction of Advanced Glycation End Products With Their Cellular Receptor RAGE: Implications for the Pathogenesis of Accelerated Periodontal Disease in Diabetes
Authors: Lalla Evanthia , Lamster Ira B. , Schmidt Ann Marie 
Published: October 2010

AbstractThe prevalence and severity of periodontal disease is increased in patients with both insulin‐deficient and insulin‐resistant forms of diabetes. While a number of underlying factors likely contribute to enhanced periodontal inflammation and alveolar bone loss in diabetes, a common characteristic of these disorders, regardless of etiology, is the presence of hyperglycemia. A critical consequence of hyperglycemia is non‐enzymatic glycation and oxidation of proteins and lipids. After a series of reversible reactions which lead to the generation of Schiff bases/Amadori products, a further series of complex molecular rearrangements ensues which results in the formation of the irreversible advanced glycation end products, or AGEs. AGEs accumulate during the process of normal aging in the plasma and tissues, but to an accelerated degree in patients with diabetes. A central means by which AGEs are believed to impart their pathogenic effects is via interaction with specific cellular receptors; the best‐characterized of these is receptor for AGE, or RAGE. RAGE, a member of the immunoglobulin superfamily of cell surface molecules, is present in increased levels on target cells in diabetes, such as endothelial cells and monocytes. One consequence of AGE‐RAGE interaction is the generation of enhanced cellular oxidant stress, a means by which cell signaling pathways may be activated, thereby resulting in altered cellular phenotype and cellular dysfunction. In this report, we will review our studies to date on AGEs and RAGE and consider the implications of their enhanced interaction in the pathogenesis of accelerated periodontal disease in diabetes. Ann Periodontol 1998;3:13–19.
Periodontal Diseases' Contributions to Cardiovascular Disease: An Overview of Potential Mechanisms
Authors: Kinane D.F. 
Published: October 2010

AbstractPeriodontitis and atherosclerosis have complex etiologies, genetic and gender predispositions, and potentially share many risk factors—the most significant of which may be smoking status. These diseases also have many pathogenic mechanisms in common. It is becoming increasingly clear that infections and chronic inflammatory conditions such as periodontitis may influence the atherosclerotic process. The severity and chronicity of periodontal disease provides a rich source of subgingival microbial and host response products and effects over a long time period. The objective of this review is to consider the mechanisms whereby diseases such as periodontitis, which is chronic and inflammatory in nature and initiated by microbial plaque, can predispose to atherosclerosis. In common with periodontal disease, the pathogenesis of atherosclerosis is not completely understood and both diseases are currently under intensive investigation. Two main processes in particular are worthy of consideration and may provide the link between these 2 diseases, namely the lipopolysaccharide‐related responses and the hyperresponsive monocyte phenomenon. Insufficient experimental evidence exists, however, to further support these hypotheses at present and clearly more research is needed on both of these processes and the interrelationships between both diseases. Ann Periodontol 1998;3:142–150.
A New Causal Model of Dental Diseases Associated With Endocarditis
Authors: Drangsholt Mark T. 
Published: October 2010

AbstractInfective endocarditis (IE) is a serious disease that is associated with dental diseases and treatment. The objective of this study was to summarize the epidemiological information about IE and reevaluate previous causal models in light of this evidence. The world biomedical literature was searched from 1930 to 1996 for descriptive and analytic epidemiological studies of IE. Multiple searching strategies were performed on 9 databases, including MEDLINE, CATLINE, and WORLDCAT. Results show that: 1) the incidence of IE varies between 0.70 to 6.8 per 100,000 person‐years; 2) the incidence of IE increases 20‐fold with advancing age; 3) over 50% of all IE cases are not associated with either an obvious procedural or infectious event 3 months prior to developing symptoms; 4) about 8% of all IE cases are associated with periodontal or dental disease without a dental procedure; 5) the time from the diagnosis of heart valve deformities to the development of IE approaches 20 years; 6) the median time from identifiable procedures to the onset of IE symptoms is about 2 to 4 weeks; 7) the risk of IE after a dental procedure is probably in the range of 1 per 3,000 to 5,000 procedures; and 8) over 80% of all IE cases are acquired in the community, and the bacteria are part of the host's endogenous flora. The synthesis of these data demonstrates that IE is a disorder with the epidemiological picture of a chronic disease such as cancer, instead of an acute infectious disease, with a long latent period and possibly several definable intermediates or stages. A new causal model is proposed that includes early bacteremias that may “prime” the endothelial surface of the heart valves over many years, and a late bacteremia over days to weeks that allows adherence and colonization of the valve, resulting in the characteristic fulminant infection. Ann Periodontol 1998;3:184–196.
The Oral Health Status of Individuals on Renal Dialysis
Authors: Naugle Kimberley , Darby Michele L. , Bauman Deborah B. , Lineberger L. Truett , Powers Ralph 
Published: October 2010

AbstractThe primary purpose of this investigation was to determine the oral health status of individuals undergoing renal dialysis in southeastern Virginia. A sample was identified for this cross‐sectional study via a local health maintenance organization. Three subgroups of the population were studied: 1) those who have been on renal dialysis for less than a year; 2) those on renal dialysis for 1 to 3 years; and 3) those on renal dialysis for longer than 3 years. Three dental indices—the Peribdontal Disease Index; the Decayed, Missing, Filled Index; and the Simplified Oral Hygiene Index—were used to identify periodontal disease, dental caries activity, and oral hygiene status. Data were compiled and analyzed by using the parametric test, 1 ‐way analysis of variance. Results suggested that 100% (n = 45) of the individuals undergoing renal dialysis presented with some form of periodontal disease ([unk] = 3.15, SD = 1.41). The majority (64%) of the sample displayed either severe gingivitis (28%) or early periodontitis (36%). Sixty‐four percent of the sample displayed a high DMF Index ([unk] = 11.77, SD = 7.55), while 98% of the sample accumulated calculus. Oral debris was present in 100% of the sample, resulting in a high Simplified Oral Hygiene Index score ([unk] = 3.24, SD = 1.26), suggesting an increased need for oral care instruction. Findings led to the conclusion that the renal dialysis population in southeastern Virginia, regardless of length of time on dialysis, is in need of comprehensive professional oral care and self‐care instruction. Oral disease was present and is a source of active infection in these medically compromised individuals and, as such, has dire implications for morbidity and mortality. Ann Periodontol 1998;3:197–205.