Impact of loading protocol of a mandibular single implant-supported complete denture on oral health-related quality of life over a period of 5 years: A randomized controlled trial.

OBJECTIVES: The aim of the present study was to assess the long-term course of OHRQoL and the impact of the loading protocol in patients receiving a single mandibular implant supporting a complete denture over a period of five years. METHODS: In this multicenter RCT, a total of 158 edentulous patients were initially included and were randomly allocated immediately after placement of a mandibular midline implant to either immediate loading (IL) or to conventional loading (CL) with submerged healing. The assessment of OHRQoL was performed with the 49-item Oral Health Impact Profile (OHIP) at baseline and 1, 4, 12, 24, and 60 months after loading. At 5-year follow-up, 100 patients (mean age: 69.2 years; 45.0% female) with completed OHIP were available for analyses. A mixed-effects model with patients as random effect and an unstructured covariance matrix was developed to address repeated outcome measurement. RESULTS: The OHRQoL improved substantially after loading, indicated by a decrease of mean OHIP summary scores from 51.0 points at baseline, by 14.2 (95%-CI: 9.4 - 19.1; p<0.001) points to 37.2 points at 1-month follow-up, and by continuous improvement to 20.4 OHIP points at final follow-up. Considering constant treatment effects, the loading protocol had no significant effect on OHIP scores (-3.7, 95%-CI: -9.4 - 2.2; p = 0.204). Time effect was statistically significant with -0.21 (95%-CI: -0.28 - -0.15; p<0.001) points per month. CONCLUSION: Both the immediate and conventional loading of a single mandibular midline implant supporting a complete denture offer long-lasting high levels of OHRQoL, with no significant or clinically relevant long-term differences. CLINICAL SIGNIFICANCE: The study firstly presents long-term data for OHRQoL by investigating the loading protocol of single mandibular implant-supported complete dentures. Since immediate loading has been associated with a reduced implant survival rate for this concept, information on patient benefits is essential for evidence-based decision making.

Survival and Complications of Single Dental Implants in the Edentulous Mandible Following Immediate or Delayed Loading: A Randomized Controlled Clinical Trial.

It was the aim of this 24-mo randomized controlled clinical trial to investigate whether the survival of a single median implant placed in the edentulous mandible to retain a complete denture is not compromised by immediate loading. Secondary outcomes were differences in prosthetic complications between the loading principles. Each of the 158 patients who received an implant was randomly assigned to the immediate loading group ( n = 81) or the delayed loading group ( n = 77). Recall visits were performed 1 mo after implant placement (for only the delayed loading group) and 1, 4, 12, and 24 mo after implant loading. Nine implants failed in the immediate loading group, all within the first 3 mo of implant loading, and 1 implant failed in the delayed loading group prior to loading. Noninferiority of implant survival of the immediate loading group, as compared with the delayed loading group, could not be shown ( P = 0.81). Consistent with this result, a secondary analysis with Fisher exact test revealed that the observed difference in implant survival between the treatment groups was indeed statistically significant ( P = 0.019). The most frequent prosthetic complications and maintenance interventions in the mandible were retention adjustments, denture fractures, pressure sores, and matrix exchanges. There was only 1 statistically significant difference between the groups regarding the parameter "fracture of the denture base in the ball attachment area" ( P = 0.007). The results indicate that immediate loading of a single implant in the edentulous mandible reveals inferior survival than that of delayed loading and therefore should be considered only in exceptional cases (German Clinical Trials Register: DRKS00003730).

Selective retina therapy for acute central serous chorioretinopathy.

AIMS: To evaluate selective retina therapy (SRT) as a treatment of acute central serous chorioretinopathy. METHODS: 30 eyes of 30 patients with central serous chorioretinopathy of at least a 3 months' duration were recruited. 14 eyes were randomised to an SRT group (Q-switched neodymium-doped yttrium lithium fluoride (Nd:YLF) laser, wavelength 527 nm, t=1.7 µs, energy 100-370 µJ, spot diameter 200 µm, pulse repetition rate 100 Hz,) and 16 eyes to a control group. After 3 months of follow-up, patients in the control group with persistence of subretinal fluid (SRF) were allocated to a cross-over group, treated with SRT and followed up for further 3 months. The main outcome measures were change of best-corrected Early Treatment Diabetic Retinopathy Study visual acuity (BCVA) and SRF. RESULTS: At 3 months of follow-up, the mean (SD) improvement of BCVA was significantly greater after SRT than in the control group: 12.7 (7.2) versus 6.3 (8.9) letters (p=0.04). SRF had decreased significantly more after SRT as compared with that the control group: 203 (136) µm versus 41 (150) µm (p=0.005). In eight eyes allocated to the cross-over group, the mean BCVA had increased during 3 months of follow up before SRT by 1.4 (5.2) letters and continued to increase during 3 months following SRT by 7.4 (6.3) letters, while SRF increased by 39.5 (160.2) µm before SRT and decreased by 151.5 (204.9) µm after SRT. In six of the eight eyes, SRF had completely resolved 3 months after SRT. CONCLUSIONS: SRT appears to expedite functional recovery and the re-absorption of SRF as compared with that in untreated controls. A larger prospective, randomised phase 3 confirmative patient study is warranted. TRIAL REGISTRATION NUMBER: NCT00987077.

Somatosensory function in asymptomatic Parkin-mutation carriers.

BACKGROUND AND PURPOSE: It is a matter of debate whether somatosensory abnormalities in Parkinson's disease (PD) precede or follow PD motor signs and whether they are of central or peripheral origin. The sensory sural nerve action potential amplitude (SNAP) was previously reported to be reduced in symptomatic Parkin-associated PD. The aim of our study was to investigate asymptomatic Parkin-mutation carriers to elucidate whether putative somatosensory abnormalities precede motor symptoms therewith helping to determine the origin of somatosensory signs. METHODS: Nine subjects with Parkin-mutations and nine healthy controls were examined clinically, with quantitative sensory testing (QST) and neurography. RESULTS: There was a higher frequency of cold pain threshold abnormalities and hypofunction of Abeta-fibres/central afferent pathways in Parkin-mutation carriers compared to controls. Neurography of Parkin-mutation carriers did not indicate peripheral neuropathy. CONCLUSIONS: Sensory abnormalities of asymptomatic Parkin-mutation carriers as obtained by QST suggest impairment of either small and large peripheral pathways or central somatosensory processing. In contrast to Parkin-associated PD, asymptomatic Parkin-mutation carriers do not show a reduced SNAP.

[Erectile dysfunction after radical prostatectomy : patient information, contact persons, postoperative proerectile therapy]. / Erektile Dysfunktion nach radikaler Prostatektomie : Aufklärung, Ansprechpartner, postoperative proerektile Therapie.

BACKGROUND: Postoperative erectile dysfunction (ED) is one of the potential after-effects of radical prostatectomy. The aim of this study was to learn which caregivers inform the patients prior to the intervention about the risk of ED, which individuals the patients discuss this issue with, and whether the patients preoperatively consider use of a PDE5 inhibitor for proerectile therapy after the operation. METHODS: Using the IIEF-5 questionnaire, the preoperative erectile function of 110 patients was evaluated after the hospital admission interview. The patients were asked who had informed them about the risk of postoperative ED. They were also asked in whom they had confided to discuss this issue and whether they were prepared to undergo postoperative proerectile therapy with a PDE5 inhibitor. The patients were subsequently assigned to one of two groups: group I, consisting of those with a preoperative IIEF score > or = 21, or group II, those with a preoperative IIEF score <21. RESULTS: The answers given by groups I and II did not differ significantly. The median patient age was the same, 68, in both groups. In addition to being informed about postoperative ED by the hospital doctor on admission (100%), the patients were informed about this by the following individuals (results for group II in parentheses): board-certified urologist, 81.8% (74%); general practitioner (GP), 27.3%; partner, 12.1% (11.7%); self-help groups, 0% (2.6%); and friends, 3% (6.5%). Patients also discussed the risk of postoperative ED with the following individuals (results for group II in parentheses): local urologist, 66.7% (63.4%); partner, 45.5% (42.9%); hospital doctor, 39.4% (42.9%); GP, 21.2% (23.4%); friends, 9.1% (14.3); or no one, 3% (5.2%). Regarding whether patients were willing to undergo postoperative therapy using a PDE5 inhibitor, 36.4% in group I and 32.5% in group II said yes, 12.1% in group I and 11.7% in group II said no, and 51.5% in group I and 55.8% in group II were undecided. CONCLUSION: Irrespective of the patient's erectile status, the hospital doctor and the local urologist informed the patients about the risk of postoperative ED. Satisfactory information delivered by at least two people occurred in over 70% of all cases. The most frequent confidant of the patient for discussing this issue was his local urologist. Fewer than 50% of the patients discussed this topic with their partners. Possible reasons for underestimating the importance of sexual function could be the frequent taboo status of sexuality as a discussion topic in relationships, as well as preoperative distress. These circumstances should be taken into account by offering sufficient information, including that on the availability of postoperative proerectile therapy, for both the patient and his partner as early as possible, i.e., at the stage of choosing a treatment option.

Somatosensory processing in a German family with PINK1 mutations: its potential role in Parkinson disease.

BACKGROUND: It is unclear whether sensory symptoms in Parkinson disease (PD) are of primary or of secondary origin attributable to motor symptoms such as rigidity and bradykinesia. OBJECTIVE: The aim of this study was to elucidate whether sensory abnormalities are present and may precede motor symptoms in familial parkinsonism by characterizing sensory function in symptomatic and asymptomatic PINK1 mutation carriers. METHODS: Fourteen family members with PINK1 mutation and 14 healthy controls were examined clinically, with nerve conduction studies and quantitative sensory testing (QST). RESULTS: Thresholds for mechanical detection, mechanical pain and pressure pain were higher in PINK1 mutation carriers compared to controls. Higher thresholds for mechanical detection, mechanical pain and pressure pain were even found in asymptomatic, clinically not or only mildly affected PINK1 mutation carriers. CONCLUSIONS: Data suggest that PINK1-associated PD is associated with a primary hypofunction of nociceptive and non-nociceptive afferent systems that can already be found at the time when motor signs of PD are only subtle. As nerve conduction studies did not reveal differences between PINK1 mutation carriers and controls, we propose that the somatosensory impairment is related to abnormal central somatosensory processing.

MRI and FDG-PET in the assessment of inflammatory aortic arch syndrome in complicated courses of giant cell arteritis.

OBJECTIVES: To evaluate the use of MRI and FDG-PET for the diagnosis and measurement of disease activity of inflammatory aortic arch syndrome in patients with complicated giant cell arteritis. METHODS: MRI and FDG-PET were performed for 25 patients with giant cell arteritis who presented with a complicated disease course despite immunosuppressive therapy. Disease activity of the thoracic aorta and the supra-aortic arteries as assessed by both modalities was compared with serological (C-reactive protein (CRP), erythrocyte sedimentation rate (ESR)) and clinical findings (Birmingham vasculitis activity score (BVAS.2)). Additionally, the usefulness of MRI for assessment of vessel wall thickening, aneurysms and stenoses was evaluated. RESULTS: In 17/25 patients, MRI disclosed structural vessel lesions suspicious for vasculitis. Active disease was detected by MRI, thoracic PET, and whole body PET in 22, 14 and 20 patients, respectively. While serological and clinical findings correlated significantly with each other, there was no concordance with MRI and only low, non-significant correlation of PET with CRP (r(s) = -0.158, 0.136), ESR (r(s) = -0.232, 0.320) and BVAS.2 (r(s) = -0.064, 0.221) for disease activity. CONCLUSIONS: MRI and PET are unreliable for assessing large-vessel inflammation in patients with giant cell arteritis and pre-existing immunosuppressive therapy. MRI is valuable for its ability to detect morphological vessel lesions, such as aneurysms and stenoses.

Fetal transabdominal biometry at 11-14 weeks of gestation.

OBJECTIVE: To establish comprehensive transabdominal ultrasonographic reference ranges for viable normal singleton human fetuses at 11-14 weeks' gestation. METHODS: Single transabdominal ultrasound measurements were taken once per pregnancy at a gestational age of between 11+0 and 14+0 weeks (crown-rump length, 45-84 mm), in viable singleton fetuses with nuchal translucency < or = 3 mm and without detectable structural anomalies, using four standard planes: (i) biparietal diameter (BPD) and fronto-occipital diameter (FOD) resulting in head circumference (HC), anterior horn (Va), posterior horn (Vp), and hemisphere (HEM); (ii) transcerebellar diameter (TCD) and cisterna magna (CM); (iii) abdominal anteroposterior (AAP) and abdominal transverse diameter (ATD) resulting in abdominal circumference (AC); and (iv) femur length (FL). The respective ratios Va/HEM, Vp/HEM, HC/AC, BPD/FL, BPD/FOD, FL/CRL, FL/BPD and FL/AC and the estimated weight were derived. Reference ranges were constructed and the mean and 5th and 95th centiles were plotted against gestation. RESULTS: There was a general increase in biometric parameters with gestation. The ratios for the ventricles vs. hemisphere and BPD/FL ratio decreased while the BPD/FOD and HC/AC ratios remained constant. Analysis of the reference range for BPD/FL was performed in both 167 and 664 fetuses and the results showed almost the identical type of equation, indicating a high degree of accuracy for the growth charts. CONCLUSIONS: We have established comprehensive reference ranges for first-trimester fetal biometry by transabdominal sonography. These charts may have a role in the diagnosis of early onset symmetrical or asymmetrical growth restriction and in the interpretation of measurements in chromosomally abnormal fetuses, and they may help in the detection of skeletal dysplasias or acrania/anencephaly.

Screening for trisomy 21 by maternal age, fetal nuchal translucency and maternal serum biochemistry at 11-14 weeks: a German multicenter study.

OBJECTIVE: To examine the effectiveness of screening for trisomy 21 by a combination of maternal age, fetal nuchal translucency (NT) thickness and maternal serum biochemistry using free beta-human chorionic gonadotropin (hCG) and pregnancy-associated plasma protein-A (PAPP-A) at 11-14 weeks of gestation. METHODS: This was a multicenter study of screening for trisomy 21 by a combination of maternal age, fetal NT and maternal serum free beta-hCG and PAPP-A at 11-14 weeks of gestation, using the methodology developed by the Fetal Medicine Foundation. The distribution of estimated risks for trisomy 21 was determined and the sensitivity and false-positive rate for a risk cut-off of 1 in 300 were calculated. RESULTS: In total, 3864 singleton pregnancies with live fetuses at 11-14 weeks were examined and the fetal NT and maternal serum free beta-hCG and PAPP-A were successfully measured in all cases. The median maternal age was 33 (range 15-46) years and, in 1271 (35.8%), the age was 35 years or more, the median gestation at screening was 12 (11-14) weeks and the median fetal crown-rump length was 64 (range 45-84) mm. The fetal NT was above the 95th centile in 73.7% (14 of 19) of trisomy 21 and in 4.8% (169 of 3505) of normal pregnancies. The estimated risk for trisomy 21 based on maternal age, fetal NT and maternal serum free beta-hCG and PAPP-A was 1 in 300 or greater in 6.6% (233 of 3505) of normal pregnancies, in 84.2% (16 of 19) of those with trisomy 21 and 88.9% (24 of 27) of those with other chromosomal defects. CONCLUSIONS: In Germany, the results of screening for chromosomal defects by measurement of fetal NT and maternal serum biochemistry, in centers with appropriately qualified sonographers, are similar to those reported in the UK using the same methodology.

Screening for trisomy 21 by fetal nuchal translucency and maternal age: a multicenter project in Germany, Austria and Switzerland.

OBJECTIVE: To examine the effectiveness of screening for trisomy 21 by a combination of maternal age and fetal nuchal translucency thickness at 10-14 weeks of gestation in Germany, Austria and Switzerland. METHODS: This was a multicenter study of screening for trisomy 21 by a combination of maternal age and fetal nuchal translucency thickness at 10-14 weeks of gestation. All the sonographers involved in the study had received The Fetal Medicine Foundation Certificate of Competence in the 10-14-week scan. Fetal nuchal translucency thickness and crown-rump length were measured in 23 805 singleton pregnancies with live fetuses. In each case the risk for trisomy 21 was estimated on the basis of maternal age and fetal nuchal translucency thickness for crown-rump length with the use of The Fetal Medicine Foundation's software. The distribution of estimated risk was determined and the sensitivity and false-positive rate for a risk cut-off of 1 in 300 was calculated. RESULTS: Fetal nuchal translucency thickness was successfully measured in all 23 805 pregnancies and outcome was available in 21 959. The median maternal age was 33 (range 15-49) years and in 7935 (36.1%) the age was 35 years or greater. The median gestation at screening was 12 (10-14) weeks and the median fetal crown-rump length was 61 (range 38-84) mm. The estimated risk for trisomy 21 based on maternal age and fetal nuchal translucency thickness for crown-rump length was 1 in 300 or greater in 13.0% (2800 of 21 475) normal pregnancies, in 87.6% (184 of 210) of those with trisomy 21 and in 87.2% (239 of 274) with other chromosomal defects. CONCLUSIONS: In Germany, Austria and Switzerland the results of screening for chromosomal defects by measurement of fetal nuchal translucency thickness, in centers with appropriately qualified sonographers and using The Fetal Medicine Foundation's software, are similar to those reported in the UK using the same methodology.