Dental devices; reclassification of root-form endosseous dental implants and endosseous dental implant abutments. Final rule

The Food and Drug Administration (FDA) is reclassifying root-form endosseous dental implants and endosseous dental implant abutments from class III to class II (special controls). Root-form endosseous dental implants are intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. Endosseous dental implant abutments are separate components that are attached to the dental implant and intended to aid in prosthetic rehabilitation. FDA is reclassifying these devices on its own initiative on the basis of new information. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for these devices. FDA is taking this action under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990, the Food and Drug Administration Modernization Act of 1997, and the Medical Device User Fee and Modernization Act of 2002.     

Dental products devices; reclassification of endosseous dental implant accessories. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is reclassifying the manually powered drill bits, screwdrivers, countertorque devices, placement and removal tools, laboratory pieces used for fabrication of dental prosthetics, trial abutments, and other manually powered endosseous dental implant accessories from class III to class I. These devices are intended to aid in the placement or removal of endosseous dental implants and abutments, prepare the site for placement of endosseous dental implants or abutments, aid in the fitting of endosseous dental implants or abutments, aid in the fabrication of dental prosthetics, and be used as an accessory with endosseous dental implants when tissue contact will last less than an hour. FDA is also exempting these devices from premarket notification. This reclassification is on the Secretary of Health and Human Services' own initiative based on new information. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (the SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA).     

Skin changes following defibrillation. The effect of high voltage direct current

Previously, electrical injuries have been suggested caused only by the concomitant heat developed during the passage of an electrical current. Recent experimental studies on fully anesthetized pigs and the study of one human case have, however, shown typical electrical alterations. The purpose of the present study was further to evaluate the histology of electrically induced changes in the skin in humans. In addition, supplementary in vivo methods for evaluation of skin changes as high-frequency ultrasound and Raman spectroscopy were used. The skin of 11 patients treated with a defibrillation of the heart was examined for macroscopic changes, the skin of eight of them also for histologic changes and for changes observable via supplementary methods. Immediately and 7 days after the defibrillation, fractions of a narrow red ring were observed along the periphery of the tin-foil electrode. Epidermis showed signs previously observed following electrical influence: segmental alterations often related to the openings of sweat ducts, darkstaining or "empty" nuclei and homogeneous cytoplasm, eosinophilic or pale. Dermis did not show the specific sign of electrical influence: deposits of calcium salts on dermal fibres, neither via histologic examination nor via high-frequency ultrasonography and Raman spectroscopy. Fractions of a narrow red ring along the periphery of the electrode showing histological signs of electric influence in epidermis thus appear to be characteristic of high voltage electrical injury.     

Dental conditions. Final rule

The Department of Veterans Affairs (VA) adopts as a final rule the proposal to amend its adjudication regulations regarding service connection of dental conditions for treatment purposes. This amendment clarifies that principles governing determinations by VA's Veterans Benefits Administration (VBA) for service connection of dental conditions for the purpose of establishing eligibility for dental treatment by VA's Veterans Health Administration (VHA), apply only when VHA requests information or a rating from VBA for those purposes. This amendment also clarifies existing regulatory provisions and reflects the respective responsibilities of VHA and VBA in determinations concerning eligibility for dental treatment.     

Dental age in Central Poland

Precise evaluation of the developmental stage of a child is an integral part of both diagnosis and treatment of pediatric patients; it is also essential in forensic medicine and dentistry. Among radiological methods for dental age estimation in children the Demirjian's method is widely used, however original standards elaborated for the French-Canadian population are mostly not suitable for other populations. The aim of the study was to compare the dental age of children from the region of Mazovia (Central Poland) with the developmental standards presented by Demirjian, to analyse sexual dimorphism of dental age in the studied group and to estimate validity of the Demirjian's standards for the studied Polish population. The material consisted of clinical files and panoramic X-ray images of 994 children aged from 6 to 16 in good general health, without development impairments. Chronological ages of the patients were established. Next dental ages were estimated by means of the Demirjian method based on developmental maturity of seven left mandibular permanent teeth. It was found that the standards were significantly different from the chronological ages in the studied population, which means that dental development was considerably accelerated. The most significant acceleration was observed in girls aged 11 and 12, as well as in 13-year-old boys; in both groups a considerable acceleration of the dental age was seen in 6-year-olds. No statistically significant differences between dental ages of girls and boys were observed in particular age groups. There were devised gender-specific equations allowing for adaptation of original Demirjian's scores for estimation of dental age in the population of Mazovia (Central Poland). In conclusion, the developmental standards used by Demirjian are not suitable in the case of the population of children of Central Poland. Therefore, it is necessary to establish new tables for this population.     

大鼠死后肝脏磷酸果糖激酶-2含量的变化

目的 分析不同死亡时间和死亡原因大鼠肝脏组织内磷酸果糖激酶-2(PFK-2)含量的变化.方法 大鼠105只随机分为三组,以不同方式(失血、窒息、断颈)处死.分别于死后0、1、2、4、8、12和24h取大鼠肝脏组织,免疫组化和图像分析技术测定大鼠PFK-2变化.结果 三组不同死亡原因大鼠肝脏组织内PFK-2的含量随死亡时间延长呈规律性减弱趋势.结论 大鼠肝脏组织内PFK-2的变化可以反映死亡时间的变化趋势.     

TRICARE; changes included in the National Defense Authorization Act for fiscal year 2005; TRICARE Dental Program. Interim final rule

The Department is publishing this interim final rule to implement sections 711 and 715 of the Ronald W. Reagan National Defense Authorization Act for Fiscal Year 2005 (NDAA-05), Public Law 108-375. Specifically, that legislation makes young dependents of deceased Service members eligible for enrollment in the TRICARE Dental Program when the child was not previously enrolled because of age, and authorizes post-graduate dental residents in a dental treatment facility of the uniformed services under a graduate dental education program accredited by the American Dental Association to provide dental treatment to dependents who are 12 years of age or younger and who are covered by a dental plan established under 10 U.S.C. 1076a. This rule also corrects certain references in 32 CFR 199.13. The rule is being published as an interim final rule with comment period in order to comply with statutory effective dates. Public comments are invited and will be considered for possible revisions to the final rule.     

应用放射影像技术进行牙龄推断

牙龄是年龄推断的重要方法之一，国外学者常将其与骨龄联合应用以提高年龄推断的准确性，但国内尚未普遍开展。大量研究表明，应用放射影像学这一无创的检查手段，可以准确观察牙齿的增龄性变化，如牙冠与牙根的发育程度、牙髓腔的变化等。目前应用放射影像学进行牙龄推断的主要方法有Gleiser和Hunt法、Demirjian法及牙髓腔测量法等。其中Demirjian法的准确性最高，但在推断法定敏感年龄时尚存在局限性。随着放射影像学的发展，尤其是CT的出现，依赖其高分辨率以及相匹配的测量软件，可提高牙龄推断的准确性与可靠性，有望成为今后推断活体年龄的重要手段。     

Identification of incinerated root canal filling materials after exposure to high heat incineration

With the increase in global terrorism there is a higher probability of having to identify victims of incineration events secondary to incendiary explosive devices. The victims of incineration events challenge forensic odontologists when coronal restorations are no longer present to compile postmortem data. With 40 million root canals being completed annually in the United States, a very large pool of antemortem data is available to the forensic odontologist to make positive identifications. When complete and thorough dental records exist, individuals that have undergone surgical and nonsurgical root canal therapy may have materials present in the canal that may aid in identification. This study provides elemental fingerprints of root canal obturation materials to be utilized as a forensic identification aid. This study used scanning electron microscopy/energy dispersive X-ray spectroscopy (SEM/EDS) to assess the elemental composition of materials before and after high temperature incineration. Sixteen endodontic materials were analyzed pre-incineration and placed in extracted teeth. The filled teeth were subjected to incineration at 900 degrees C for 30 min to simulate incineration events or cremation. Incinerated materials were radiographed and re-analyzed to determine if they retained their original elemental composition. Endodontic sealers, gutta percha, root-end filling materials, silver points, and separated files were distinguishable in the canal and traceable after incineration. The authors present a fingerprint of the endodontic obturation materials that are capable of withstanding high heat incineration to be used as an aid for postmortem identification. This work represents the initial stage of database generation for root canal filling materials for use as an aid in forensic identification.     

Dental anesthetic death. An unusual autoerotic episode

The details of an unusual autoerotic death are presented; the postulated method of induction of cerebral hypoxia was inhalation of nitrous oxide from a dental anesthetic machine; the theme of dental anesthesia, presumably an elaborate bondage fetish, recurred in documentary material found at the scene.     

Dental identification using digital images via computer network

Dental identification is a useful scientific method. In Japan, however, there are only a few forensic odontologists; moreover, until now, forensic dental services have only been offered by general dentists. These dentists may not be able to offer such forensic services during office time. For a quick comparison, the authors tried sending digital photos, taken with a 2-million-pixel digital camera, to dental offices via the Internet. If a dental office has Internet access, it is possible for dental charting to be sent directly to the autopsy room. Of course, digital images only provide the first outline. However, when antemortem dental records of the person in question are available at autopsy, a quick comparison can be made.     

TRICARE; changes included in the National Defense Authorization Act for Fiscal Year 2010; expansion of survivor eligibility under the TRICARE Dental Program. Final rule

The Department is publishing this final rule to implement the National Defense Authorization Act for Fiscal Year 2010 (NDAA for FY10), as amended by the National Defense Authorization Act for Fiscal Year 2011 (NDAA for FY11). Specifically, that legislation expands the survivor eligibility under the TRICARE Dental Program (TDP). The 2011 amendment to the legislation entitles the surviving spouse and child(ren) continuation of eligibility for the TDP regardless of whether they were previously enrolled in the TDP. Prior enrollment in the TDP had been a requirement of the 2010 legislation for both the spouse and children. The period of continued eligibility for a spouse will be 3 years beginning on the date of the member's death. The legislation entitles a child to continuation of eligibility for the TDP for the longer of three years or until age 21 (or 23 for most full-time students). Survivors, who meet the new eligibility requirements, will obtain TDP eligibility as of the publishing of the final rule in the Federal Register. Retroactive payment of premiums or claims paid for dental treatment during the time of loss of TDP eligibility will not be reimbursed to surviving dependents.     

The Delta Dental case: "Fair procedure" comes to managed care. Delta Dental Plan of California v. Banasky

All providers contemplating managed care contracts, both individual and institutional, should carefully review the health plans' internal administrative review and dispute resolution procedures before making their decisions, especially if the contracts will represent significant income for the provider. While there may be judicial recourse in California and in other states that adopt the holding in Delta Dental, in other states providers may well be held to the health plans' internal administrative decisions as a matter of contractual agreement. Health plans should also review their own policies and procedures for adequacy under applicable state law. The health care community will not know the full extent of Delta Dental's implications until later cases area decided, but for now it seems certain that another wave of change in this area is just beginning.     

Dental identification problems in the Abu Dhabi air accident

The forensic odontological examination of 112 victims in the 1983 air accident near Abu Dhabi is described with particular reference to the problems encountered in the age assessment of the 26 children, and serves to illustrate that dental identification in aviation accidents may be of only limited application in Asian victims. Following this accident, other means of identification had misguidedly been removed by the recovery teams. Of those identified, half were by dental means alone, but this amounted to only 6.24% of the total number of victims.     

Root Morphology and Anatomical Patterns in Forensic Dental Identification: A Comparison of Computer‐Aided Identification with Traditional Forensic Dental Identification*

Abstract: An online forensic dental identification exercise was conducted involving 24 antemortem–postmortem (AM–PM) dental radiograph pairs from actual forensic identification cases. Images had been digitally cropped to remove coronal tooth structure and dental restorations. Volunteer forensic odontologists were passively recruited to compare the AM–PM dental radiographs online and conclude identification status using the guidelines for identification from the American Board of Forensic Odontology. The mean accuracy rate for identification was 86.0% (standard deviation 9.2%). The same radiograph pairs were compared using a digital imaging software algorithm, which generated a normalized coefficient of similarity for each pair. Twenty of the radiograph pairs generated a mean accuracy of 85.0%. Four of the pairs could not be used to generate a coefficient of similarity. Receiver operator curve and area under the curve statistical analysis confirmed good discrimination abilities of both methods (online exercise = 0.978; UT‐ID index = 0.923) and Spearman’s rank correlation coefficient analysis (0.683) indicated good correlation between the results of both methods. Computer‐aided dental identification allows for an objective comparison of AM–PM radiographs and can be a useful tool to support a forensic dental identification conclusion.     

Dental age estimation and third molars: a preliminary study

The aim of the present investigation was to reconstruct the chronological age based on the dental developmental stages of third molars evaluated on orthopantomograms. A total of 1175 orthopantomograms were assembled from patients of Caucasian origin between 16 and 22 years of age. Each third molar present was scored by two observers according to a 10-stage developmental scale. The kappa statistics measured the intra- and inter-observer reliability. The general statistical analysis was based on multiple regression analysis in order to obtain multiple regression formulas for dental age estimation based on the number of third molars present on the evaluated orthopantomogram. No regression models were statistically significant when there was only one-third molar present because of the relatively small number of orthopantomograms that fitted this criterion. A strong agreement was found between the intra- and inter-observer measurements. The statistical analysis revealed both for males and females high Pearson correlation coefficients between contralateral third molars and smaller coefficients between antimeres. The obtained multiple regression formulas are only applicable in certain specified conditions, for instance when four third molars are present the following formulas should be used in a Caucasian male "age=10.2000+0.5122UL+0.5273LL" (developmental stage of upper and lower left third molars) or in case of a female "age=13.6206+0.1933UR+0.5080LR" (developmental stage of upper and lower right third molars). This investigation revealed that the chronological age of a Caucasian individual may be estimated based on regression formulas with a S.D. of 1.52 or 1.56 years for males and females, respectively, when all four third molars are present.     

Study of Chilean Children’s Dental Maturation*

Abstract: In forensic science, determining a person’s chronological age has become a challenge for researchers. Determining age using dental calcification is becoming increasingly important. The objective of this study is to estimate the dental age of the children’s population in Region VIII, Chile. The sample was randomly taken from children under the care of the Faculty of Dentistry at the Universidad de Concepción in Chile. The study encompasses 159 children between 3 and 14 years of age. The dental age was determined following the Demirjian method. The Bland–Altman method was applied to establish the correlation. It was determined that the range between chronological and dental age is similar, and the degree of correlation between both ages is nearly perfect. In conclusion, the degree of correlation between the chronological and dental ages for each gender is also very good although it is slightly higher for females.