5-year randomized multicenter clinical trial on single dental implants placed in the midline of the edentulous mandible.

OBJECTIVES: This multicenter randomized controlled clinical trial was conducted to investigate whether the loading protocol of single dental implants placed in the midline of edentulous mandibles will influence the implant survival or prosthetic maintenance. MATERIALS AND METHODS: In total, 158 patients were randomly assigned either to the immediate loading group (n = 81) or to the delayed loading group (n = 77). All implants were loaded with an overdenture retained by a ball attachment. RESULTS: After 5 years, 102 patients attended the follow-up investigation. Immediately loaded single implants in the midline of the edentulous mandible revealed a statistically significant lower survival rate than implants loaded conventionally over an observation period of 5 years. In the immediate loading group, 9 implants failed within the first three months of implant loading. No further implant loss was recorded for this group. Two implants failed in the delayed loading group, whereas one implant had to be removed during second-stage surgery and the second five years after implant loading. Non-inferiority of the survival rate of the midline implant of the immediate loading group, compared with the delayed loading group, could not be shown (p = .79, CI immediate loading: 74.9%; 100.0%, CI delayed loading: 73.0%; 100.0%). The observed difference in implant survival between the two treatment groups over time was statistically significant. CONCLUSIONS: The results of the present study indicate that immediate loading of a single mandibular implant in the edentulous mandible should be considered only in exceptional cases.

X chromosomal variation is associated with slow progression to AIDS in HIV-1-infected women.

AIDS has changed from a mostly male-specific health problem to one that predominantly affects females. Although sex differences in HIV-1 susceptibility are beyond doubt, the extent to which sex affects the onset and progression of AIDS has remained elusive. Here, we provide evidence for an influence of X chromosomal variation on the course of retroviral infection, both in HIV-1-infected patients and in the rhesus macaque model of AIDS. A two-stage, microsatellite-based GWAS of SIV-infected monkeys revealed MHC class I markers and a hitherto-unknown X chromosomal locus as being associated with a nominal score measuring progression to AIDS (Fisher's exact p < 10(-6)). The X chromosomal association was subsequently confirmed in HIV-1-infected patients with published SNP genotype data. SNP rs5968255, located at human Xq21.1 in a conserved sequence element near the RPS6KA6 and CYLC1 genes, was identified as a significant genetic determinant of disease progression in females (ANOVA p = 8.8 x 10(-5)), but not in males (p = 0.19). Heterozygous female carriers of the C allele showed significantly slower CD4 cell decline and a lower viral load at set point than TT homozygous females and than males. Inspection of HapMap revealed that the CT genotype is significantly more frequent among Asians than among Europeans or Africans. Our results suggest that, in addition to the individual innate and adaptive immunity status, sex-linked genetic variation impacts upon the rate of progression to AIDS. Elucidating the mechanisms underlying this sex-specific effect will promote the development of antiretroviral therapies with high efficacy in both sexes.

Biochemical tissue-specific injury markers of the heart and brain in postpartum cord blood.

OBJECTIVE: We sought to establish references ranges and to test the hypothesis that biochemical tissue-specific markers for the heart in umbilical cord blood of newborns with cardiac defects and intrauterine growth restriction (IUGR) are abnormal. STUDY DESIGN: A prospective study was conducted. Serum samples of the umbilical vein (n = 280) and artery (n = 156) from 599 healthy newborns at 37(+0)-42(+0) weeks of gestation were collected. Total creatine kinase (CK), CK-MB heart type (CK-MB), cardiac troponin T (cTnT), myoglobin, N-terminal pro-B-type natriuretic peptide (NT-proBNP), and S100 were measured. Reference ranges for each marker were constructed. Concentrations of tissue-specific markers from umbilical cord blood of neonates with cardiac defects (n = 10) and IUGR (n = 41) were plotted against the established reference ranges. RESULTS: Reference ranges for each studied marker were established for both umbilical artery and vein. In fetuses with cardiac defects, both NT-proBNP (4/6 [66%] in the artery, 7/10 [70%] in the vein) and cTnT (2/10 [20%] in the vein) were increased. In fetuses with IUGR in the vein, NT-proBNP (10/41 [24%]) and cTnT (5/41 [12%]) were increased, whereas S100 (9/41 [21%]) was decreased. CONCLUSION: In a subset of neonates with cardiac defects or growth restriction, irrespective of the pH at birth, tissue-specific injury markers for the heart in umbilical cord blood are abnormal.

Single mandibular implant study (SMIS) - masticatory performance - results from a randomized clinical trial using two different loading protocols.

OBJECTIVES: This multi-centre randomized controlled trial was conducted to investigate, whether the masticatory performance of elderly edentulous patients is improved by placement of a single implant in the midline of the edentulous mandible, and whether improvements differ with respect to the loading protocol, i.e., implant is loaded either directly or three months later after second stage surgery. METHODS: Edentulous seniors aged 60-89 years were screened according to inclusion and exclusion criteria and 163 underwent implant placement. Of those, 158 were randomly assigned either to the direct loading group A (n=81) or the conventional loading group B (n=77). Chewing efficacy was obtained before treatment, one month after implant placement during the submerged healing phase (only group B) and 1 and 4 months after implant loading. RESULTS: The masticatory performance increased over time in both groups. Four months after loading, a significant increase was observed for both groups compared to the baseline data without implant (p≤0.05). However, between the two groups, chewing efficiency did not differ significantly at any point in time (p>0.05). CONCLUSIONS: A single midline implant in the edentulous mandible increases masticatory performance significantly, independently from the loading protocol. CLINICAL SIGNIFICANCE: A single midline implant in the edentulous mandible increases masticatory performance. The loading protocol has no influence.

Single Mandibular Implant Study: Recruitment Considerations.

PURPOSE: The aim of this multicenter single mandibular implant study was to compare the clinical outcome of an immediately loaded implant placed in the midline of an edentulous mandible with the clinical outcome when closed healing and delayed loading is chosen. Here, the patient recruitment period and the main reasons for exclusion were analyzed. MATERIALS AND METHODS: Patient recruitment was performed at nine German universities. Rather conservative inclusion and exclusion criteria, including denture satisfaction, denture status, a psychologic symptom checklist, and a defined bone height in the posterior mandible, had to be fulfilled. It was initially calculated that 230 persons would have to be screened within 13 months to include 180 persons in the trial. RESULTS: Within 13 months (December 2012 to December 2013), 201 patients were screened for possible inclusion in the trial and 148 met the inclusion criteria. Finally, after the recruitment period was extended by 2.5 months, 224 patients were screened and 169 were included. Of those screened, 55 (24.6%) did not meet the inclusion criteria and were excluded. Another 4 patients (1.8%) were excluded based on their psychologic symptom checklist score, while 5 others (2.8%) showed signs of noncompliance. A further 8 patients (4.4%) decided not to participate and withdrew their informed consent, and another 3 (1.3%) were no longer available after screening. Another 2 patients were excluded due to medical contraindications and 1 due to an insufficient mandibular denture. In 34 cases (15.2%), the residual bone height did not comply with McGarry type II or III. CONCLUSION: Within the limitations of this patient recruitment period, it can be concluded that residual bone height is the most important factor when considering elderly edentulous patients for implant therapy. The psychologic symptom checklist score was less important.

Single dental implant retained mandibular complete dentures--influence of the loading protocol: study protocol for a randomized controlled trial.

BACKGROUND: Over the years, there has been a strong consensus in dentistry that at least two implants are required to retain a complete mandibular denture. It has been shown in several clinical trials that one single median implant can retain a mandibular overdenture sufficiently well for up to 5 years without implant failures, when delayed loading was used. However, other trials have reported conflicting results with in part considerable failure rates when immediate loading was applied. Therefore it is the purpose of the current randomized clinical trial to test the hypothesis that immediate loading of a single mandibular midline implant with an overdenture will result in a comparable clinical outcome as using the standard protocol of delayed loading. METHODS/DESIGN: This prospective nine-center randomized controlled clinical trial is still ongoing. The final patient will complete the trial in 2016. In total, 180 edentulous patients between 60 and 89 years with sufficient complete dentures will receive one median implant in the edentulous mandible, which will retain the existing complete denture using a ball attachment. Loading of the median implant is either immediately after implant placement (experimental group) or delayed by 3 months of submerged healing at second-stage surgery (control group). Follow-up of patients will be performed for 24 months after implant loading. The primary outcome measure is non-inferiority of implant success rate of the experimental group compared to the control group. The secondary outcome measures encompass clinical, technical and subjective variables. The study was funded by the Deutsche Forschungsgemeinschaft (German research foundation, KE 477/8-1). DISCUSSION: This multi-center clinical trial will give information on the ability of a single median implant to retain a complete mandibular denture when immediately loaded. If viable, this treatment option will strongly improve everyday dental practice. TRIAL REGISTRATION: The trial has been registered at Deutsches Register Klinischer Studien (German register of clinical trials) under DRKS-ID: DRKS00003730 since 23 August 2012. (http://www.germanctr.de).

Hepatic aminotransferases of normal and IUGR fetuses in cord blood at birth.

BACKGROUND: The accepted standard for assessing the wellbeing of the newborn is the Apgar score and blood gas analysis. However, the prediction of neonatal morbidity or mortality is limited. In small-for-gestation (SGA) fetuses at 18-38 weeks of gestation, pO(2) is <5th centile both in the umbilical artery and vein in 30%. In a previous study in singleton term neonates cardiac specific enzymes (B-type natriuretic peptide, BNP and cardiac troponin T, cTnT) are increased in growth-restricted fetuses compared with normals. AIMS: To test the hypothesis, that fetuses with intra uterine growth restriction (IUGR) have elevated AST (GOT) and ALT (GPT) aminotransferases as a result of hypoxic liver cell injury, and to establish references ranges. STUDY DESIGN: Prospective cohort study, serum of umbilical artery (n=156) and vein (n=180), 599 normal singletons at 37(+0)-42(+0)weeks, neonates with IUGR (n=41), analysis for pH, birthweight and maternal weight, spontaneous vs cesarean section, vein vs artery and for the sex. OUTCOME MEASURES: Aspartate aminotransferase (AST, GOT) and Alanine aminotransferase (ALT, GPT) were measured in normals and IUGR neonates. RESULTS: Neonates with IUGR (n=41) had AST values that were not different from the reference group, but had significantly lower ALT (-1.49, 95% CI -1.98 to -1.00 vs 0.14, 95% CI -0.42-0.13), (p<0.001), (Fig. 3). CONCLUSIONS: In neonates with IUGR, hypoxic hepatic injury markers in cord blood were not elevated. Rather, a substantially reduced ALT suggests a down-regulated hepatic activity.

Reconstruction of the lower lip: rationale to preserve the aesthetic units of the face.

BACKGROUND: The boundaries of the aesthetic units of the face are often crossed after lower lip cancer surgery. The aim of this study was to compare the aesthetic and functional outcome after use of different operative techniques based on the concept of the aesthetic units of the face. MATERIALS: Sixty-three patients were evaluated after lower lip reconstruction. The aesthetic outcome was recorded by standard photography evaluating the disruption of the boundaries of the aesthetic units of the face, lip projection, and the resulting facial expression. The functional outcome consisted of the evaluation of mouth opening, pouting, and lips at rest for the evaluation of mouth continence. Three techniques were used: wedge excision, the Webster-Fries method, and the step technique. The step technique was combined with an Abbé or an Estlander flap in defects involving more than two-thirds of the lip. RESULTS: In defects involving up to one-third of the lip, the aesthetic outcome was better for the step technique than for wedge excision (a statistical trend was observed, p = 0.088). In defects involving two-thirds of the lip, the aesthetic and functional outcome was better using the step technique than the Webster-Fries method (p = 0.002), because the boundaries of the aesthetic units are respected. In defects involving more than two-thirds of the lip, the result was better using the step technique combined with the Abbé flap. CONCLUSION: The authors have shown that the step technique alone or combined with a flap of the opposite lip is a rational approach for preserving the aesthetic units of the face and its function.

Fetal transabdominal anatomy scanning using standard views at 11 to 14 weeks' gestation.

OBJECTIVES: This study was undertaken to investigate fetal anatomy with the use of standard views and a scoring system, to investigate interobserver variability, and to compare ultrasound modes simultaneously with the measurement of nuchal translucency (11-14 weeks' gestation). STUDY DESIGN: Twelve fetal anatomic regions were defined as standard views (n = 60) and assessed with the use of a scoring system (1 = not seen, 2 = seen uncertainly, 3 = seen acceptably, 4 = well seen, and 5 = very well seen). The variation of scores and interobserver variability were analyzed (n = 40), the B-mode was compared with tissue harmonic and compound imaging (n = 60). RESULTS: The overall average score (11 + 0 to 13 + 6 weeks) with tissue harmonic and compound imaging was 3.56 (well seen) and increased with gestation. The highest score was for the neck and the lowest for the cerebellum. The proportion of identical scores for each given region showed a range of 58% to 83%. Tissue harmonic and compound imaging was significantly better than the plain B-mode, P < .001 (sign test). CONCLUSION: Transabdominal fetal anatomy scanning with standard fetal anatomy views at 11 to 14 weeks of gestation is possible with good reproducibility and demonstrability when harmonic and compound imaging are used.