A Randomized Clinical Trial Evaluating rh-FGF-2/ß-TCP in Periodontal Defects.

Biological mediators have been used to enhance periodontal regeneration. The aim of this prospective randomized controlled study was to evaluate the safety and effectiveness of 3 doses of fibroblast growth factor 2 (FGF-2) when combined with a ß-tricalcium phosphate (ß-TCP) scaffold carrier placed in vertical infrabony periodontal defects in adult patients. In this double-blinded, dose-verification, externally monitored clinical study, 88 patients who required surgical intervention to treat a qualifying infrabony periodontal defect were randomized to 1 of 4 treatment groups-ß-TCP alone (control) and 0.1% recombinant human FGF-2 (rh-FGF-2), 0.3% rh-FGF-2, and 0.4% rh-FGF-2 with ß-TCP-following scaling and root planing of the tooth prior to a surgical appointment. Flap surgery was performed with EDTA conditioning of the root prior to device implantation. There were no statistically significant differences in patient demographics and baseline characteristics among the 4 treatment groups. When a composite outcome of gain in clinical attachment of 1.5 mm was used with a linear bone growth of 2.5 mm, a dose response pattern detected a plateau in the 0.3% and 0.4% rh-FGF-2/ß-TCP groups with significant improvements over control and 0.1% rh-FGF-2/ß-TCP groups. The success rate at 6 mo was 71% in the 2 higher-concentration groups, as compared with 45% in the control and lowest treatment groups. Percentage bone fill in the 2 higher-concentration groups was 75% and 71%, compared with 63% and 61% in the control and lowest treatment group. No increases in specific antibody to rh-FGF-2 were detected, and no serious adverse events related to the products were reported. The results from this multicenter trial demonstrated that the treatment of infrabony vertical periodontal defects can be enhanced with the addition of rh-FGF-2/ß-TCP (ClinicalTrials.gov NCT01728844).

The simplified papilla preservation flap in the regenerative treatment of deep intrabony defects: clinical outcomes and postoperative morbidity.

BACKGROUND: The aims of the present multi-center, randomized, controlled clinical trial were: 1) to compare the efficacy of the simplified papilla preservation flap with and without a barrier membrane in deep intrabony defects; 2) to evaluate the postoperative morbidity and surgical complications; and 3) to preliminarily test the impact of baseline tooth mobility on clinical outcomes. METHODS: This parallel group, randomized, multi-center, controlled clinical trial involved 112 patients in 8 periodontal practices in 4 countries. A deep intrabony defect in each patient was accessed with the simplified papilla preservation flap. In the test defects, a bioabsorbable membrane was positioned. Patients' experiences with the surgical procedure and postoperative period were evaluated with a questionnaire. Clinical outcomes included clinical attachment level (CAL) and probing depth (PD) changes. RESULTS: Complete observations were available for 55 test and 54 control defects. CAL gains at 1 year were 3.5 +/- 2.1 mm in the guided tissue regeneration (GTR) group and 2.6 +/- 1.8 mm in the control group (P = 0.0117). CAL gains > or = 4 mm were observed in 50.9% of GTR sites and 33.3% of control sites. A significant center effect of 2.1 mm was observed (P= 0.01). Initial PD (P= 0.01) and baseline tooth mobility (P= 0.036) were significant covariates. During the procedure, 30.4% of test and 28.6% of controls reported feeling moderate pain, and subjects estimated the hardship of the procedure at 24 +/- 25 visual analog scale (VAS) units in the test group, and at 22 +/- 23 VAS in controls. In terms of the investigated outcomes, differences between test and control groups were not statistically significant. Among the postoperative complications, edema was most prevalent at week 1, and more frequently associated with the test treatment (P= 0.01). In the test group, 53.6% of membranes were exposed at week 3. CONCLUSIONS: The present study further supports the added benefits of guided tissue regeneration with respect to access flap alone in the treatment of deep intrabony defects, as well as the general efficacy of GTR in different clinical settings. Furthermore, our study indicates a possible influence of baseline tooth mobility on clinical outcomes.

Data elements for emergency department systems, release 1.0 (DEEDS): a summary report. DEEDS Writing Committee.

Variations in the way that data are entered in ED record systems impede the use of ED records for direct patient care and deter their reuse for many other legitimate purposes. To foster more uniform ED data, the Centers for Disease Control and Prevention's (CDC) National Center for Injury Prevention and Control is coordinating a public-private partnership that has developed recommended specifications for many observations, actions, instructions, conclusions, and identifiers that are entered in ED records. The partnership's initial product. Data Elements for Emergency Department Systems, Release 1.0 (DEEDS), is intended for use by individuals and organizations responsible for ED record systems. If the recommended specifications are widely adopted, then problems--such as data incompatibility and high costs of collecting, linking, and using data--can be substantially reduced. The collaborative effort that led to DEEDS, Release 1.0 sets a precedent for future review and revision of the initial recommendations.

Data elements for emergency department systems, release 1.0 (DEEDS): a summary report. DEEDS Writing Committee.

Variations in the way that data are entered in emergency department record systems impede the use of ED records for direct patient care and deter their reuse for many other legitimate purposes. To foster more uniform ED data, the Centers for Disease Control and Prevention's National Center for Injury Prevention and Control is coordinating a public-private partnership that has developed recommended specifications for many observations, actions, instructions, conclusions, and identifiers that are entered in ED records. The partnership's initial product, Data Elements for Emergency Department Systems, Release 1.0 (DEEDS), is intended for use by individuals and organizations responsible for ED record systems. If the recommended specifications are widely adopted, then problems--such as data incompatibility and high costs of collecting, linking, and using data--can be substantially reduced. The collaborative effort that led to DEEDS, Release 1.0 sets a precedent for future review and revision of the initial recommendations.

Evaluating a new algorithm for linking maternal and newborn medical records.

Linking material and newborn medical records is a valuable tool for assessing the relationship between maternal variables and fetal outcome. This study evaluated the Center for Disease Control's newly developed maternal and newborn medical record linkage system, a computer program that uses weighted variables to determine the most likely maternal and newborn pairs. Any newborn record not achieving a set minimum score with a maternal record remains nonmatched. The objectives of the study were to estimate the program's matching accuracy, determine causes of incorrect matches and nonmatches, develop suggestions for program revisions, and evaluate the effects of the revisions. The study sample included 521 matched and 247 nonmatched maternal and newborn medical records from seven Ohio hospitals. Of all available newborn records (10,068), 574 (5.7%) did not match with maternal records; for those in which a match occurred, the authors ascertained a 98% matching accuracy and determined explanations for nonmatched and incorrectly matched records. The authors noted a greater prevalence of birth defects and prematurity among newborns with nonmatched records than among those with matched records. Program revisions, therefore, focused on reducing the prevalence of nonmatched records. The revised program reduced the prevalence of nonmatched records from 5.7% to 3% but reduced matching accuracy.

Clinical and radiographic healing pattern observations with combined regenerative techniques.

Clinical and radiographic healing observations were categorized into four patterns: rapid, typical, delayed, and adverse. While considerable overlap of characteristics was noted between the categories, singular factors or combinations of factors enabled pattern identification. The factor primarily associated with the rapid healing pattern was the appearance of bone in the former defect adjacent to the membrane at removal. In contrast, the adverse healing pattern depicted surface necrosis or loss of tissue height at membrane removal. One hundred random sites were evaluated, revealing 13% rapid healing patterns, 76% typical healing patterns, 8% delayed healing patterns, and 3% adverse healing patterns. With favorable patient compliance with oral hygiene and follow-up care, the rapid and typical healing patterns became clinically successful cases. The level of clinical success varied with the delayed healing pattern; the adverse pattern failed to achieve the therapeutic objective.

Geographic patterns of fatal abuse or neglect in children younger than 5 years old, United States, 1979 to 1988.

OBJECTIVE: To examine geographic patterns of fatal child abuse or neglect (CAN) among children younger than 5 years old. DESIGN: A death certificate-based model to estimate the occurrence of fatal CAN. SETTING: United States, 1979 to 1988. PARTICIPANTS: The population of children younger than 5 years old. INTERVENTIONS: None. MAIN RESULTS: We estimate that from 868 to 1815 deaths annually occur among children younger than 5 years old from CAN. The lower figure is the estimate of confirmed CAN, and the higher is the estimate of the sum of confirmed, probable, and possible CAN. Death rates were highest in the South and West, intermediate in the North Central, and lowest in the Northeast. A threefold difference was noted between rates in the lowest- and highest-ranking states (ie, Connecticut, 2.9 to 5.2 per 100,000, and Nevada, 6.7 to 15.4 per 100,000, respectively). When the 39 largest metropolitan areas were ranked, a similar variation between the lowest and the highest was observed (ie, Boston, Mass, 2.7 to 5.5 per 100,000, and Phoenix, Ariz, 6.6 to 15.5 per 100,000, respectively). CONCLUSION: Understanding the sizable geographic variation in CAN deaths rates could lead to effective interventions. If the US fatality rate were reduced to that of Connecticut, between 434 and 908 fewer CAN deaths might occur annually.

Estimates of fatal child abuse and neglect, United States, 1979 through 1988.

The results of recent surveys in the United States have suggested a rising tide of fatalities due to child abuse or neglect (CAN). Because these surveys lack consistency in case definition and are incomplete in coverage, the use of death certificate data to estimate the number of CAN deaths was explored. To estimate these deaths among children 0 through 17 years old for 1979 through 1988, three models were formulated, each comprising six coding categories: (1) deaths coded explicitly as due to CAN, (2) homicides, (3) injury deaths of undetermined intentionality, (4) accidental injury deaths, (5) sudden infant death syndrome fatalities, and (6) natural-cause deaths. Research studies and crime data were relied on to estimate the proportions of deaths in categories 2 through 6 that were actually due to CAN, and other assumptions were varied to create a range of estimates. For the 10-year period, the estimated mean annual CAN fatalities ranged from 861 to 1814 for ages 0 through 4, and from 949 to 2022 for ages 0 through 17. Child abuse and neglect death rates did not increase over the period; in fact, they were relatively stable for ages 0 through 17 and showed a modest decline for 0 through 4. Ninety percent of fatal CAN occurs among children younger than 5 years old, and 41% occurs among infants. About 85% of CAN deaths are recorded as due to other causes.(ABSTRACT TRUNCATED AT 250 WORDS)

Long-term assessment of combined osseous composite grafting, root conditioning, and guided tissue regeneration.

Although the short-term success of guided tissue regeneration has been widely reported, few studies on the long-term success of treatment have been published. The present investigation assessed the 5-year results of guided tissue regeneration procedures used alone or in combination with root conditioning and osseous composite grafts. Results indicated that the long-term success of guided tissue regeneration was significantly enhanced by the addition of root conditioning and grafting procedures.

Trauma registries. Current status and future prospects.

Hospital trauma registries are evolving rapidly as a result of a renewed focus on trauma care evaluation and recent advances in microcomputer technology. In theory, trauma registries can serve as the principal tool for the systematic audit of the quality of patient care provided by a hospital or a trauma system and as a potential source of part of the data needed for injury surveillance. In practice, however, there is a tendency to underestimate the resources needed to initiate and maintain a registry. Herein, we describe the purposes, resource requirements, and limitations of trauma registries. We conclude that standardization of case criteria, core data content, data definitions, and coding conventions can enhance the utility of trauma registries.

A microcomputer program for coding external cause of injury.

The publication of Injury in America emphasized a renewed interest in the scientific study of trauma. Collection and analysis of population-based data were viewed as necessary prerequisites for the establishment and evaluation of injury prevention programs. While it was noted that there is an existing broad-based gathering of injury mortality information, it was also made clear that there is a paucity of systematically collected morbidity data. A fundamental step toward correcting this deficiency is to identify and adopt a uniform system for coding causes of injury morbidity that is compatible with the large body of mortality data currently being collected. This paper describes a microcomputer-based program, which is intended to aid in the selection of External Cause of Injury Codes (E-codes). It is designed for coding both fatal and nonfatal injury causes and is appropriate for use in the hospital setting. The system is a modification of the one currently used for coding all injury deaths in the United States.