Prospective Clinical Pilot Study Research Articles

Immediate Implant Placement in the Aesthetic Area using Inverted Body-shift Design: A Prospective Clinical Pilot Study.

A prospective clinical pilot study was carried out to evaluate a novel macroimplant design with a 12° angled platform. The implant is placed at the center of the socket, optimizing all the alveolar bone. In addition, the prosthetic emergence should be ideal, as it is corrected and emerges through the cingulate area. Twelve patients were enrolled in an immediate implant placement procedure with immediate aesthetic rehabilitation to replace an anterior maxillary tooth, and were treated with inverted body-shift design with 12° angled neck. Only type I sockets according to the Elian classification were considered eligible for the study. There were no implant failures after one year of loading. Regarding the horizontal and vertical hard tissue changes, there was a statistically significant median overall horizontal change of -0.99 mm at 1 mm and of -0.61 mm at 3 mm. On the other hand, stability was observed at 5 mm, since the result obtained was not statistically significant. The median pink esthetic score (PES) at one year of follow-up was 11.5. This implant may be useful in the immediate tooth replacement treatment of maxillary anterior post-extraction sockets, nevertheless, comparative studies with conventional implants should be carried out.

Prediction of a Difficult Airway Using the ARNE Score and Flexible Laryngoscopy in Patients with Laryngeal Pathology.

Background and Objectives: The ARNE score was developed for the prediction of a difficult airway for both general and ear, nose and throat (ENT) surgery with a universal cut-off value. We tested the accuracy of this score in the case of laryngeal surgery and provided an insight into its effects in combination with flexible laryngoscopy. Materials and Methods: This prospective pilot clinical study included 100 patients who were being scheduled for microscopic laryngeal surgery. We calculated the ARNE score for every patient, and flexible laryngoscopy was provided preoperative. Difficult intubation was assessed according to the intubation difficulty score (IDS). Results: A total of 33% patients had difficult intubation according to the IDS. The ARNE score showed limited accuracy for the prediction of difficult intubation in laryngology with p < 0.0001 and an AUC of 0.784. Flexible laryngoscopy also showed limitations when used as an independent parameter with p < 0.0001 and an AUC of 0.766. We defined a new cut-off value of 15.50 for laryngology, according to the AUC. After the patients were divided into two groups, according to the new cut-off value and provided cut-off value, the AUC improved to 0.707 from 0.619, respectively. Flexible laryngoscopy improved the prediction model of the ARNE score to an AUC of 0.882 and of the new cut-off value to an AUC of 0.833. Conclusions: It is recommended to use flexible laryngoscopy together with the ARNE score in difficult airway prediction in patients with laryngeal pathology. Also, the universally recommended cut-off value of 11 cannot be effectively used in laryngology, and a new cut-off value of 15.50 is recommended.

Safety and efficacy of autologous bone marrow clot as a multifunctional bioscaffold for instrumental posterior lumbar fusion: a 1-year follow-up pilot study.

Bone marrow aspirate (BMA), when combined with graft substitutes, has long been introduced as a promising alternative to iliac crest bone graft in spinal fusion. However, the use of BMA is limited by the absence of a standardized procedure, a structural texture, and the potential for diffusion away from the implant site. Recently, the potential use of a new formulation of BMA, named BMA clot, has been preclinically described. In this report, we present the results of a prospective pilot clinical study aimed at evaluating the safety and efficacy of autologous vertebral BMA (vBMA) clot as a three-dimensional and multifunctional bioscaffold in instrumented posterior lumbar fusion. Ten consecutive patients with an indication of multilevel (≤5) posterior spinal fusion due to lumbar spine degenerative diseases were included in the study and treated with vBMA. Clinical outcomes were assessed using the Visual Analog Scale (VAS), Oswestry Disability Index (ODI), and EuroQoL-5L (EQ-5L) preoperatively and at 3 months and 12 months after spinal fusion. Bone fusion quality was evaluated at the 12-month follow-up using the Brantigan classification on radiography (XR) imaging. Bone density was measured on computed tomography (CT) scans at 6 and 12 months of follow-up visits at the intervertebral arches and intervertebral joint areas and expressed in Hounsfield unit (HU). The results indicate a successful posterolateral fusion rate of approximately 100% (considering levels with C, D, and E grades according to the Brantigan classification) at the 12-month follow-up, along with an increase in bone density from 6 to 12 months of follow-up. An improvement in the quality of life and health status following surgery, as assessed by clinical scores (ODI, VAS, and EQ-5L), was also observed as early as 3 months postsurgery. No adverse events related to the vBMA clot were reported. This prospective pilot study demonstrates the effectiveness and safety profile of vBMA clot as an advanced bioscaffold capable of achieving posterior lumbar fusion in the treatment of degenerative spine diseases. This lays the groundwork for a larger randomized clinical study.

A pilot study analyzing the influence of the material and the size of the orthodontic archwire on the level of pain and anxiety in adult patients in treatment with brackets: A prospective triple-blind randomized clinical trial.

The objective was to investigate the influence of the material and dimensions of the orthodontic archwire on the pain and anxiety in adult patients in orthodontic treatment with brackets. A randomized prospective triple-blind clinical pilot study was conducted at the Dental Clinic of the University of Salamanca. The study sample comprised 30 adult patients who started orthodontic treatment with brackets. This sample was divided into two groups: the NiTi group (n=15) and Cu-NiTi group (n=15). Pain was analyzed with a visual analogue scale (VAS) and anxiety with the State-Trait Anxiety Inventory (STAI). Anxiety was assessed at the start of treatment (T0) and after one month (T1). Pain was analyzed at the start of treatment (T0), at different time points at the start (T01), and after 4 (T02), 24 (T03), and 48 hours (T04); these measurements were also recorded one month after starting orthodontic treatment (T11, T12, T13, and T14). The mean age of patients was 31.3 (± 6.05) years old. The highest level of pain, at the beginning of treatment, was observed after 48 hours (5.57 ± 1.72) and at one month after starting treatment at 24 hours (5.13 ± 1.89), with no significant differences between the two groups. When analyzing anxiety, no differences were observed between groups; the anxiety levels were higher one month after starting treatment compared to the start. Regarding the correlation between pain and anxiety, the NiTi group showed a greater direct relationship (<0.05) between these two variables at the start of treatment in the anxiety trait in relation to pain at T02 and T03 and after a month in T12, T13, and T14. In the sample studied, there was no significant influence of the size or material of the orthodontic archwire on pain and anxiety levels. Key words:Orthodontics, Brackets, Archwire, Pain, Anxiety, NiTi, Cu-NiTi.

Polymer-Coated Urinary Catheter Reduces Biofilm Formation and Biomineralization: A First-in-Man, Prospective Pilot Study

Purpose: Biofilm formation and biomineralization on urinary catheters may cause severe complications including infection and obstruction. Here, we describe an in vitro evaluation and prospective pilot clinical study of a silicone catheter coated with a biofilm-resistant polymer. Materials and Methods: Biofilm biomass and biomineralization on uncoated and coated catheters were quantified by confocal microscopy using fluorescently tagged bacteria or stained for biofilm and minerals. Biomineral identity was determined using scanning electron microscopy and X-ray spectroscopy. Biofilm formation and biomineralization were evaluated in vitro using uropathogens Proteus mirabilis and Pseudomonas aeruginosa and on catheters recovered from hospitalized patients. Fibrinogen in patient urine and on catheters was quantified using an immunofluorescence assay. Results: In vitro P. mirabilis and P. aeruginosa formed significantly less biofilm and biomineral and failed to block coated compared with uncoated catheters in a bladder model after 89 h. Biofilm-resistant polymer-coated catheters (n = 83) recovered from hospitalized patients exhibited significantly lower biofilm biomass and biomineralization compared with uncoated silicone catheters (n = 78). Electron microscopy with elemental analysis of recovered catheters revealed calcium oxalate crystals on coated compared with the struvite and apatite crystals on uncoated catheters associated with catheter blockage. Lower levels of biofilm-promoting fibrinogen in postcatheterization urine and on catheters from patients receiving coated catheters was observed compared with those receiving uncoated catheters indicative of a reduced inflammatory response. Conclusions: These data provide evidence that polymer-coated urinary catheters exhibit enhanced resistance to fibrinogen deposition, biofilm formation, and encrustation, reducing the risks associated with catheter-associated urinary tract infections and obstruction.

Non-compressive sleeves versus compression stockings after total knee arthroplasty: A prospective pilot study

BackgroundCompression stockings are routinely prescribed after total knee arthroplasty (TKA). Non-compressive sleeves embedded with semiconductor elements (Incrediwear) are designed to enhance blood flow. The objective of this investigation is to compare compression stockings and Incrediwear on post-TKA measures. MethodsIn this single-center prospective clinical pilot study, patients undergoing TKA were assigned to either the compression stocking (control) or Incrediwear (experimental) group. Subjects were evaluated preoperatively and postoperative at 3 weeks for pain, knee effusion, knee range of motion (ROM), thigh and calf circumferences. ResultsIncrediwear subjects had slightly higher preoperative effusion than controls (mean effusion 1.38 vs. 1.16, p = .28); however, by week 3, Incrediwear subjects had lower levels of effusion than controls (1.12 vs. 1.56, p = .015). At week 3, when compared to pre-op, Incrediwear subjects experienced a 19% decrease in effusion while controls experienced a 35% increase in effusion (p = .003). Preoperatively, there were no differences observed between Incrediwear subjects and controls flexion ROM (mean ROM 117 vs. 116, p = .67); however, by week 3, Incrediwear subjects had greater flexion ROM than controls (113 vs. 108, p = .02). Incrediwear subjects experienced only a 3% decrease in flexion ROM while controls experienced a 7% decrease in ROM (p = .07). Incrediwear subjects reported higher preoperative pain than controls (mean pain 4.2 vs. 3.2, p = .051); however, by week 3, there was no difference observed between these groups (2.9 vs. 3.0, p = .440). DiscussionNon-compressive sleeves embedded with semiconductor elements (Incrediwear) appeared to reduce effusion and improve knee flexion better than traditional compression stockings 3 weeks after total knee arthroplasty.

Efficacy and Side Effects of Denosumab for Stage 3b-4 CKD Patients with Osteoporosis: An Open-Label, Prospective Pilot Clinical Study

Efficacy and Side Effects of Denosumab for Stage 3b-4 CKD Patients with Osteoporosis: An Open-Label, Prospective Pilot Clinical Study

Evaluation of a protocol to assess a novel artificial biofilm equivalent for dentures-A prospective clinical pilot study.

This pilot study aimed to carry out preliminary tests of the removability of an artificial biofilm equivalent (ABE) and to verify the reproducibility of the ABE testing protocol for a planned main study. There is a lack of data to develop suitable artificial biofilm substitutes, which may be helpful to perform denture hygiene education and to carry out in vitro examinations of oral hygiene products. This single-group, prospective, longitudinal, interventional pilot study was conducted in Dresden (Germany) from February until December 2020. Participants were recruited who wore fully functional upper complete dentures. Denture biofilm was grown on acrylic specimens by wearing dentures for 12 h and 36 h using intraoral appliances. Acrylic specimens were coated with ABEs of three compositions: chitosan (ChS) 0.3 g, methylcellulose (MC) 1.7 g; ChS 0.2 g, MC 1.8 g; ChS 0.1 g, MC 1.9 g (labelled 1.7MC, 1.8MC and 1.9MC, respectively). All specimens underwent standardised mechanical brushing. The percentages of remaining biofilm (POB) were measured. Thirty-one participants were prescreened, and eight (26%) were included. The appliances were well tolerated, and biofilm was collected. ABE was prepared and brushed as planned. Three and six brushing strokes were needed to remove 12-h and 36-h natural denture biofilm, respectively. Correspondingly, three brushing strokes were needed to remove 1.9MC ABE and six brushing strokes to remove 1.8MC and 1.7MC ABE. A reproducibility of ABE removal was indicated. The removability of ABE and the ABE testing protocol were feasible and reproducible for conducting the future main study.

Clinical outcomes of periodontal regenerative therapy with carbonate apatite granules for treatments of intrabony defects, Class II and Class III furcation involvements: A 9-month prospective pilot clinical study

IntroductionCarbonated apatite (CO3Ap) has unique properties as an alloplastic bone substitute and has been reported the safety and efficacy for bone regeneration. However, no previous studies reported the clinical application of CO3Ap for periodontal regeneration therapy. The aim of this study was to evaluate the safety and efficacy of periodontal regeneration with CO3Ap in treating intrabony defects, Class II and Class III furcation involvement (FI). MethodsA single-arm and single-center prospective pilot clinical study was performed to verify the safety and efficacy of CO3Ap in patients with periodontitis. A total of four patients with seven teeth, including three deep intrabony defects, two Class II FI, and two Class III FI, were treated with CO3Ap. The clinical parameters, including probing pocket depth (PPD), clinical attachment level (CAL), bleeding on probing (BOP), tooth mobility (Mo), Plaque index (PI), and Gingival index (GI) were evaluated at baseline, 6 months, and 9 months after the surgery. Radiographic analysis was conducted on images of dental X-ray and cone beam computed tomography (CBCT) at baseline and 9 months post-surgery. ResultsThe postoperative healing in all cases was uneventful, with no abnormal bleeding, pain, or swelling. The mean PPD reduction and CAL gain were 5.0 ± 1.0 mm, 4.5 ± 0.7 mm, 1.5 ± 0.7 mm, and 4.7 ± 1.2 mm, 4.5 ± 0.7 mm, 0.0 mm for intrabony defect, Class II and Class III FI, respectively. According to radiographic analysis, linear bone height in intrabony defects and vertical subclassification of FI in Class II FI were improved. ConclusionsThe clinical application of CO3Ap for the treatment of intrabony defects and Class II FI could be effective for periodontal regeneration, although its efficacy in treating Class III FI might be limited. Despite the limitations of this study, the findings in this study suggested that CO3Ap has the potential to be a promising bone graft substitute for periodontal regeneration.

Evaluation of the Efficacy of Nanofat Injection in Treatment of Androgenic Alopecia

Abstract Background Androgenic alopecia is the most common hair loss disorder in both males and females. The importance of this disease comes from the immense emotional distress that it leaves on the patient caused by the hair loss. The terminal hair follicles over the frontal and vertex regions are replaced by miniaturized hair follicles which leads progressively to a visible reduction in hair density. Aim of the Work To evaluate the efficacy of Nanofat injected into the scalp for management of androgenic alopecia. Patients and Methods This prospective clinical pilot study included 20 patients with androgenic alopecia, 10 males and 10 females, attending Dermatology outpatient clinic of Ain Shams University Hospitals from December 2020 to July 2021. Results Our results showed clinically significant improvement by comparing patients’ photographs in most of the treated patients and high mean patients’ satisfaction with minor encountered side effects. Moreover, dermoscope revealed significant increased median terminal hair density in all patients 6 months after nanofat session. Conclusion Although the exact mechanism of action is still unclear, nanofat injection can be considered an effective treatment modality for androgenic alopecia. Yet, further studies are needed with a bigger number of cases to minimize statistical errors and to detect the most accurate nanofat isolation method yielding best results.

Correlation between Accuracy in Computer-Guided Implantology and Peri-Implant Tissue Stability: A Prospective Clinical and Radiological Pilot Study.

The present pilot study was designed by hypothesizing a possible correlation between lack of accuracy in implant placement and peri-implant hard and soft tissue health. A total of five patients underwent computer-guided implant surgery and full-arch immediate loading between 2013 and 2014. They subsequently underwent postoperative cone-beam computed tomography (CBCT). After a follow-up of 5 years, all patients were recalled for a clinical-radiographic evaluation of peri-implant health status. The mean linear deviation was 0.5 ± 0.2 mm at the implant's head and 0.6 ± 0.2 mm at the implant's apex, while the mean angular deviation of the long axis was 2.8° ± 1.2°. A mean marginal bone loss (MBL) of 1.16 ± 0.94 mm and 2.01 ± 1.76 mm was observed after 1 and 5 years of follow-up, respectively. At 5 years, the mean peri-implant probing depth (PPD) was 4.09 ± 1.44 mm, 66.6% of the evaluated implants showed peri-implant bleeding on probing (BOP), keratinized mucosa (KM) was <2 mm in 48.4% of cases, and mucosal recession (REC) ≥ 1 mm was assessed in 45.4% of the included implants. A negative correlation was observed between bucco-palatal/lingual linear inaccuracy and MBL, PPD, BOP, and KM.

Cardiac surgery elicits pericardial inflammatory responses that are distinct compared with postcardiopulmonary bypass systemic inflammation

ObjectivesCardiac surgery using cardiopulmonary bypass contributes to a robust systemic inflammatory process. Local intrapericardial postsurgical inflammation is believed to trigger important clinical implications, such as postoperative atrial fibrillation and postsurgical intrathoracic adhesions. Immune mediators in the pericardial space may underlie such complications. MethodsIn this prospective pilot clinical study, 12 patients undergoing isolated coronary artery bypass graft surgery were enrolled. Native pericardial fluid and venous blood samples (baseline) were collected immediately after pericardiotomy. Postoperative pericardial fluid and venous blood samples were collected 48-hours after cardiopulmonary bypass and compared with baseline. Flow cytometry determined proportions of specific immune cells, whereas multiplex analysis probed for inflammatory mediators. ResultsNeutrophils are the predominant cells in both the pericardial space and peripheral blood postoperatively. There are significantly more CD163lo macrophages in blood compared with pericardial effluent after surgery. Although there are significantly more CD163hi macrophages in native pericardial fluid compared with baseline blood, after surgery there are significantly fewer of these cells present in the pericardial space compared with blood. Postoperatively, concentration of interleukin receptor antagonist 6, and interleukin 8 were significantly higher in the pericardial space compared with blood. After surgery, compared with blood, the pericardial space has a significantly higher concentration of matrix metalloproteinase 3, matrix metalloproteinase 8, and matrix metalloproteinase 9. The same trend was observed with transformational growth factor β. ConclusionsCardiac surgery elicits an inflammatory response in the pericardial space, which differs from systemic inflammatory responses. Future work should determine whether or not this distinct local inflammatory response contributes to postsurgical complications and could be modified to influence clinical outcomes.

Horizontal Bone Augmentation With Autogenous and Collagenated Xenogeneic Bone Blocks: A Split-Mouth Prospective Clinical, Tomographic, and Histological Pilot Study.

The aim of this study was to compare the clinical, tomographic, and histological performance of collagenated xenogeneic bone blocks (CXBB) in horizontal bone augmentations for implant placement. Five patients with an absence of the 4 upper incisors and an HAC 3 horizontal bone defect, with a remaining of 3 to 5 mm, underwent a bone-grafting procedure with CXBB (test group [TG], n = 5) and autogenous graft (control group [CG], n = 5), with one type of graft used on the right side and other type on the left side. Changes in bone thickness and density (tomographic evaluation), levels of complications (clinically), and distribution pattern between mineralized and nonmineralized tissue (histomorphometrically) were analyzed. Tomographic analysis showed a horizontal bone increase of 4.25 ± 0.78 mm in the TG and 3.08 ± 0.8 mm in the CG between baseline and 8 months postoperatively (P < .05). The horizontal loss between the day of installation of the blocks and 8 months postoperatively was 1.02 ± 0.39 mm for the TG and 1.10 ± 0.71 mm for the CG (P > .05). With regard to bone density, the TG blocks right after installation had 440.2 ± 89.15 HU, and after 8 months, the region reached 730.7 ± 130.98 HU, representing an increase of 29.05%. For the CG blocks, bone density increased from 1052.2 ± 398.35 HU to 1222.5 ± 453.28 HU, representing an increase of 17.03%. The increase in bone density was significantly higher in the TG (P < .05). Clinically, no cases of exposure of the bone blocks and no failure of incorporation were observed. Histomorphometrically, the percentage of mineralized tissue was lower in the TG than in the CG (48.10% ± 2.88% and 53.53% ± 1.05%, respectively), and the opposite was verified for the levels of nonmineralized tissue (52.79% ± 2.88% and 46.47% ± 1.05%, respectively; P < .05). The use of CXBB achieved higher levels of horizontal gain, with lower bone density and lower levels of mineralized tissue when compared with the use of autogenous blocks.

Putting the “f”etus back in maternal-fetal telemedicine: a prospective pilot study

Hybrid care programs bring advantages of virtual visits (cost, logistics and comfort) and in-person visits (doctor-patient relationship and extended clinical evaluation). For maternal-fetal telemedicine to become a mainstream of MFM, the virtual visits must be comprehensive, and extend beyond maternal assessment to fetal wellbeing. We sought to assess the feasibility of hybrid care for women with gestational diabetes mellitus (GDM). A prospective pilot clinical study. Women with a singleton pregnancy and GDM at ≥31 weeks of gestation were recruited. Patient journey included alternating in-person and remote visits for a duration of four weeks. The remote visit included maternal assessment - vital signs, glycemic control (documented in Datos app), urinalysis (Healthy.io), fetal heart rate assessment (INVU by Nuvo™) and ultrasound measured maximal vertical pocket (PulseNmore) yielding a modified biophysical profile (mBPP) [Figure1]. Total visit length was compared between the virtual and in-person visits. Usefulness, effectiveness, reliability, and patient satisfaction were assessed with the telehealth usability questionnaire (TUQ). 20 participants with GDM between 31-34 gestational weeks at recruitment were enrolled [Table1]. One participant withdrew consent after one virtual visit. 38/39 (97.4%) of remote visits concluded in comprehensive assessment including mBPP to the physician's satisfaction. One referral to in-person monitoring occurred due to technical difficulties. Total remote visit length was significantly shorter (65.4±21.6 min) compared to the in-person visit (171.1±21.4 min, P< 0.001). TUQ results indicate high usability of the telehealth system (6.6/7). No adverse events or safety incidents occurred. A hybrid maternal-fetal program consisting of alternating in-person and virtual visits is feasible, saves time and improves women satisfaction. Use of the service and technologies requires a learning process for both the care team and the women. Shifting maternal-fetal surveillance to women’s home or work has broad implications with many advantages.View Large Image Figure ViewerDownload Hi-res image Download (PPT)

Changes of the nociceptive flexion reflex threshold in patients undergoing cardiac surgery-a prospective clinical pilot study.

Opioid dosage for general anaesthesia and sedation relies on surrogate parameters such as heartrate and blood pressure. This implies the risk of both under- and overdosing. A promising tool to provide target-oriented opioid dosing is measuring the nociceptive flexion reflex threshold (NFRT). The aim of this study was to investigate the individual trajectories and to determine this methods' clinical practicability in the perioperative setting of cardiac surgery. NFRT was measured preoperatively (twice as baseline), immediately after surgery and later in the general ward (primary outcomes). No intraoperative measurements were performed since neuromuscular blockade hinders NFRT assessment. Administered analgesics and pain scores were also recorded (secondary outcomes). Data were collected from August 2019 to March 2020. 264 patients scheduled for cardiac surgery were screened for eligibility. 55 patients were included, 30 rendered datasets for analysis. Thresholds after conclusion of surgery [TICU: median (IQR), 31.1mA (21.5-50.0mA)] were significantly higher than preoperatively [Tpre: 9.2mA (5.4-13.4mA); P < 0.001]. In 11 patients (36.7%), no immediate postoperative reflex response was elicited. Later, all reflexes returned, but thresholds remained significantly higher than preoperatively [Tpost: 11.9mA (9.2-16.6mA); P = 0.043]. NFRT values after surgery were higher compared to baseline measurements. Subsequently they decreased but did not reach their baseline levels. There was no corresponding dose-dependency, suggesting multimodal effects on the nociceptive system. Unless measurements are not prevented by technical issues NFRT-assessment appears to be a future tool to target analgesics in patients not able to self-report pain. Trial registration Study registration: DRKS00021617. https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00021617 (registered retrospectively).

Non-invasive sampling procedure revealing the molecular events at different abutments of bone-anchored hearing systems-A prospective clinical pilot study.

To investigate the molecular activities in different compartments around the bone-anchored hearing system (BAHS) with either electropolished or machined abutments and to correlate these activities with clinical and microbiological findings. Twelve patients received machined or electropolished abutments after implant installation of BAHS. Peri-abutment fluid and tissue were collected from baseline to 12 months. Gene expression of cytokines and factors related to tissue healing and inflammation, regeneration and remodelling, as well as bacterial recognition were determined using quantitative-polymerase chain reaction (qPCR). The clinical status was evaluated using the Holgers scoring system, and bacterial colonisation was investigated by culturing. The gene expression of inflammatory cytokines (IL-8, IL-1β, and IL-10) and bacteria-related Toll-like receptors (2 and 4) was higher in the peri-abutment fluid than at baseline and in the peri-abutment tissue at 3 and 12 months. Conversely, the expression of genes related to tissue regeneration (Coll1a1 and FOXO1) was higher in the tissue samples than in the peri-abutment fluid at 3 and 12 months. Electropolished abutments triggered higher expression of inflammatory cytokines (IL-8 and IL-1β) (in peri-abutment fluid) and regeneration factor FOXO1 (in peri-abutment tissue) than machined abutments. Several cytokine genes in the peri-abutment fluid correlated positively with the detection of aerobes, anaerobes and Staphylococcus species, as well as with high Holger scores. This study provides unprecedented molecular information on the biological processes of BAHS. Despite being apparently healed, the peri-abutment fluid harbours prolonged inflammatory activity in conjunction with the presence of different bacterial species. An electropolished abutment surface appears to be associated with stronger proinflammatory activity than that with a machined surface. The analysis of the peri-abutment fluid deserves further verification as a non-invasive sampling and diagnostic procedure of BAHS.

A prospective pilot study of a gluten-free diet for primary sclerosing cholangitis and associated colitis.

Primary sclerosing cholangitis (PSC) is a progressive bile duct disease associated with inflammatory bowel disease (PSC-IBD). To investigate whether patients with PSC-IBD benefit from a gluten-free and amylase trypsin inhibitor (ATI)-free diet (GFD). We performed a prospective clinical pilot study administering an eight-week GFD. The primary outcomes were colonic inflammation assessed by proctosigmoidoscopy, and liver stiffness (surrogate for fibrosis, inflammation and cholestasis) measured by transient elastography before and after GFD. Amongst the secondary (exploratory) outcomes were colonic mucosal and serum cytokine/chemokine changes, the intestinal microbiome and transcriptome dynamics, and shifts in serum markers of hepatic fibrogenesis. Fifteen patients with PSC-IBD completed the study. The study did not meet its primary outcome: the endoscopic score and liver stiffness remained unchanged. However, the expression of pro-inflammatory mucosal cytokines and chemokines such as IL6, IL8, CCL2, and TNFα was significantly down-regulated. Two critical markers of liver fibrosis and matrix remodelling, thrombospondin-2 and -4, decreased significantly. The microbiota composition changed slightly, including a decrease in the pathogen Romboutsia ilealis. The intestinal transcriptome indicated a gut barrier improvement. Pruritus, fatigue, overall well-being, faecal calprotectin levels, and serum alkaline phosphatase did not change significantly. This study did not demonstrate a clinical improvement with short-term GFD in patients with PSC-IBD. However, a gluten/ATI-free diet may improve biomarkers of intestinal inflammation and barrier function in these patients with associated changes in the enteric microbiota. Further investigation of the therapeutic potential of the GFD in PSC-IBD is warranted.

Beneficial effects of Pilates exercise on female sexual dysfunction: A prospective pilot study

ObjectiveFemale sexual dysfunction (FSD) is a significant public health issue, and it has a high global prevalence. Few effective treatment options are available for the treatment of FSD. We conducted a prospective clinical pilot study to investigate the beneficial effects of Pilates exercise on sexual function in women with FSD. MethodsWomen aged between 20 and 50 years and who had regular menstrual cycles and sexual relationships and participating Pilates exercise program were asked to complete Beck Depression Inventory (BDI) and Female Sexual Function Index (FSFI) questionnaires before starting the Pilates exercise program. If the total FSFI score was less than 26.55, which is the cut-off for FSD, the subject was invited to participate in the study. Primary endpoints were changes in total and individual domain scores on the FSFI and BDI. ResultsA total of 36 premenopausal women were included in the study. After a 12-week Pilates program, all domains of the FSFI were significantly improved, with mean±SD total FSFI scores increasing from 12.0±4.9 to 29.3±3.4 (P<0.0001). BDI scores were significantly decreased from 25.1±14.3 to 1.6±3.7 (P<0.0001) after the exercise program. ConclusionsThis pilot study showed that Pilates exercise could improve sexual functions in women with FSD. Pilates may facilitate the treatment of sexual dysfunction in women.

Prospective Evaluation of Health-Related Quality of Life in Patients with Metastatic Urothelial Carcinoma Undergoing Immunotherapy with Pembrolizumab: Symptom Burden Can Predict Survival

Introduction: Despite the fact that guidelines recommend monitoring of quality of life during all phases of treatment in urothelial carcinoma, prospective data about health-related quality of life (HRQoL) in metastatic urothelial carcinoma undergoing immunotherapy are sparse. Consequently, we performed a prospective clinical pilot study about HRQoL using the Functional Assessment of Cancer Therapy – Immune Checkpoint Modulator (FACT-ICM) questionnaire. Materials and Methods: Formally, this study is a prospective uni-centric noninterventional observation from January 2021 to December 2021. Results: Fourteen patients with a mean age of 73.9 years (SD 8.8) participated in the study. The physical well-being subscale of FACT-G is most impaired during therapy with mean scores of 7.5, 6.2, and 4.0 followed by the emotional well-being. The FACT-G total score is stable during therapy with mean scores of 51.1, 50.4, and 48.0 and it is not significantly decreasing during therapy (p = 0.317). Furthermore, the symptom burden of these patients is low and not significantly changing over time (p = 0.500), but survival decreases significantly if symptom burden is high (FACT-ICM score over 40; p < 0.001). Conclusion: Physical and emotional needs have a strong impact on HRQoL and should be dealt with during treatment. If symptom burden is high, survival decreases. This needs further evaluation.

The use of autogenous tooth bone graft powder in the treatment of osseous defects after impacted mandibular third molar extraction: a prospective split-mouth clinical pilot study

BackgroundImpaction of mandibular third molars (M3) is one of the most common diseases. Extraction of M3 usually exacerbates osseous defects at the distal aspect of the adjacent second molar (M2). BonMaker® ATB has been cited as a novel autogenous bone grafting material. The aim of this pilot study was to introduce a novel method for repairing the distal osseous defects of M2 after the surgical removal of M3 with autogenous tooth graft powder (ATGP).MethodA total of five patients were enrolled in this prospective split-mouth clinical pilot study. Four impacted wisdom teeth were extracted bilaterally from each patient with proximal alveolar bone loss ≥ 5 mm of M3. The ATGP was prepared chairside from two extracted one side third molars and randomly implanted in one of the M3 extraction sockets, and the other side was treated with a blank and considered the control site. Patients were followed up at 6 months.ResultsThe five patients included three males and two females. Their ages ranged from 25 to 30 years, with a median of 27 years. Primary wound healing without complications was achieved in all the patients. There was a greater tendency for swelling of the cheeks and trismus to occur at the experimental site on the third postoperative day. Compared with the control site, the experimental site exhibited progressive bone filling and ossification in the sixth postoperative month. Moreover, the probing pocket depth of the experimental site was lower than that of the control site.ConclusionThe results of this study demonstrate that ATGP effectively and economically repairs distal osseous defects of M2. Further study is required to validate the effectiveness with a larger study population.