Randomized Clinical Pilot Study Research Articles

The effect of different sweeteners on the oral microbiome: a randomized clinical exploratory pilot study

ABSTRACT Introduction The aim of the study was to evaluate the modulating effects of five commonly used sweetener (glucose, inulin, isomaltulose, tagatose, trehalose) containing mouth rinses on the oral microbiome. Methods A single-centre, double-blind, parallel randomized clinical trial was performed with healthy, 18–55-year-old volunteers (N = 65), who rinsed thrice-daily for two weeks with a 10% solution of one of the allocated sweeteners. Microbiota composition of supragingival dental plaque and the tongue dorsum coating was analysed by 16S RNA gene amplicon sequencing of the V4 hypervariable region (Illumina MiSeq). As secondary outcomes, dental plaque red fluorescence and salivary pH were measured. Results Dental plaque microbiota changed significantly for two groups: inulin (F = 2.0239, p = 0.0006 PERMANOVA, Aitchison distance) and isomaltulose (F = 0.67, p = 0.0305). For the tongue microbiota, significant changes were observed for isomaltulose (F = 0.8382, p = 0.0452) and trehalose (F = 1.0119, p = 0.0098). In plaque, 13 species changed significantly for the inulin group, while for tongue coating, three species changed for the trehalose group (ALDEx2, p < 0.1). No significant changes were observed for the secondary outcomes. Conclusion The effects on the oral microbiota were sweetener dependant with the most pronounced effect on plaque microbiota. Inulin exhibited the strongest microbial modulating potential of the sweeteners tested. Further full-scale clinical studies are required.

Soft tissue esthetics around immediately provisionalized delayed implants with and without connective tissue graft: A randomized clinical trial pilot study

Evaluate the peri-implant soft tissue esthetics following a single, immediately provisionalized, delayed implant with/-out subepithelial connective tissue graft (SCTG). The eligible patients were randomized into two groups. Immediate provisionalization was performed with (test group: SCTGG) or without SCTG (control group: NGG). The soft tissue esthetics was assessed by Pink Esthetic Score (PES) and Mucosal Scarring Index (MSI), at 6 and 12 months, following final implant restoration. The SCTGG, compared to NGG, yielded a 0.2 increased PES at 12 months (95% confidence interval (CI): -1, 1.4) and a 0.2 decreased MSI score (95% CI -0.9, 0.5) with no statistically significant differences in PES and MSI between both groups (p > 0.05). Soft tissue grafting around immediately provisionalized delayed implants could exhibit comparable results to immediate provisionalization alone in terms of peri-implant soft tissue esthetics using PES and MSI (ClinicalTrials.gov Identifier: NCT03770975).

Comparison of romosozumab versus denosumab treatment on bone mineral density after 1 year in rheumatoid arthritis patients with severe osteoporosis: A randomized clinical pilot study.

To investigate the effect of romosozumab versus denosumab treatment on bone mineral density (BMD), disease activity, and joint damage in patients with rheumatoid arthritis and severe osteoporosis. Fifty-one postmenopausal women were enrolled and randomized equally into two groups to receive either romosozumab or the denosumab. Changes (Δ) in the BMD (at lumbar spine, total hip, and femoral neck), disease activity score in 28 joints (DAS28)-erythrocyte sedimentation rate (ESR), and van der Heijde-modified Total Sharp Score (TSS) from baseline to 12 months after treatment were evaluated. The ΔBMD at 12 months in the romosozumab and denosumab groups were 10.2 ± 5.6% and 5.0 ± 3.1% (p = .002) for the lumbar spine, 3.7 ± 4.9% and 3.5 ± 3.0% (p = .902) for the total hip, and 3.6 ± 4.7% and 3.2 ± 4.9% (p = .817) for the femoral neck, respectively. The ΔDAS28-ESR and ΔTSS at 12 months did not differ between these two groups. Our results suggest that romosozumab treatment was more effective in increasing the BMD at the lumbar spine than denosumab and may be selected for patients who require a significant increase in the lumbar spine BMD.

Optimization of vonoprazan-amoxicillin dual therapy for eradicating Helicobacter pyloriinfection in China: A prospective, randomized clinical pilot study.

Vonoprazan-amoxicillin (VA) dual therapy has been shown to achieve acceptable cure rates for treatment of Helicobacter pylori(H. pylori) in Japan. Its effectiveness in other regions is unknown. We aimed to explore the efficacy of VA dual therapy as first-line treatment for H. pyloriinfection in China. This was a single center, prospective, randomized clinical pilot study conducted in China. Treatment naive H. pyloriinfected patients were randomized to receive either low- or high-dose amoxicillin-vonoprazan consisting of amoxicillin 1 g either b.i.d. or t.i.d plus VPZ 20 mg b.i.d for 7 or 10 days. 13 C-urea breath tests were used to access the cure rate at least 4 weeks after treatment. Three hundred and twenty-three patients were assessed, and 119 subjects were randomized. The eradication rates of b.i.d. amoxicillin for 7 and 10 days, t.i.d. amoxicillin for 7 and 10 days were 66.7% (16/24), 89.2% (33/37), 81.0% (17/21), and 81.1% (30/37) (p=.191) by intention-to-treat analysis, respectively, and 72.7% (16/22), 89.2% (33/37), 81.0% (17/21), and 81.1% (30/37) (p=.454) by per-protocol analysis, respectively. Neither 7- or 10-day VA dual therapy with b.i.d. or t.i.d. amoxicillin provides satisfied efficacy as the first-line treatment for H. pyloriinfection in China. Further optimization is needed.

Comparison of volume-controlled, pressure-controlled, and chest compression-induced ventilation during cardiopulmonary resuscitation with an automated mechanical chest compression device: A randomized clinical pilot study

Aim of the studyAutomated mechanical chest compression devices (AMCCDs) can help performing high-quality cardiopulmonary resuscitation (CPR). Guidelines for CPR are lacking information about the optimal ventilation mode during CPR using AMCCDs. Aim of this pilot study was to compare three common ventilation modes during CPR using AMCCD. MethodsIn this randomized controlled trial, we included patients with an out-of-hospital cardiac arrest arriving at the resuscitation room receiving chest compressions via AMCCD with an expected continuation of at least 15 min. Patients were randomly assigned to three groups: biphasic positive airway pressure with assisted spontaneous ventilation (BIPAP) with assisted spontaneous breathing, continuous positive airway pressure (CPAP) and volume-controlled ventilation (VCV). Outcomes were tidal volume, respiratory minute volume, and end-tidal CO2 during the study period. Groups were compared using generalized linear models. Data is given as median and interquartile ranges. ResultsOf 53 screened patients, 30 were randomized. The tidal volume was significantly (p < 0.05) lower in patients of the CPAP group (68 [64–83] ml) compared with those of the BIPAP (349 [137–500] ml), while the respiratory minute volume differed between the CPAP group (6.2 [5.3–8.1] l/min) and both the BIPAP (7.1 [6.7–10.2] l/min) and VCV group (7.2 [3.7–8.4] l/min). ConclusionsAll ventilation modes achieved an adequate respiratory minute volume during CPR with an AMCCD. However, BIPAP seems to be superior due to the higher tidal volume. Therefore, we recommend starting mechanical ventilation when using AMCCD with BIPAP ventilation to avoid risks related to dead space ventilation.

Pilot Randomized Clinical Trial Study: Comparative Study of 10% Lidocaine Hydrochloride Solution with Lidocaine Prilocaine Emulsion Prior to Local Anesthetic Injection

Background: The pain caused by the injection of local anesthetic has been reported as one of the main complaints of dental patients. Topical anesthetics are widely used drugs in dentistry, mainly to control pain associated with the needle penetration in the administration of local anesthesia. Objective: The present study aimed to evaluate (5%,7.5% and 10%) concentrations of lidocaine/prilocaine agent, compared to the common 10% lidocaine hydrochloride spray in the oral cavity. Materials and Methods: This was a split-mouth double-blind, randomized clinical trial pilot study. We randomized 15 patients, ages 35 to 64 years, with American Society of Anesthesiologists I and II with severe chronic periodontitis who were referred to the dental clinic for surgery, to receive 4 topical anesthetics (5%, 7.5%, and 10%) lidocaine prilocaine emulsion and 10% lidocaine hydrochloride topical anesthetic agent before local infiltration. Primary outcomes were assessing drug safety and pain level that measured by assessment of visual analog scale (VAS) scores of pain during LA injection in the first premolar and second molar in each maxillary quadrant in 15 patients corresponding to the posterior superior alveolar nerve (PSA) and secondary outcome was the relationship between age and gender regarding pain perception, and a total of 60 regions were analyzed. Results: Results revealed that there was no statistically significant difference between lidocaine hydrochloride and (5%,7.5% and 10%) lidocaine prilocaine in terms of pain reduction when the 4 different compounds were compared. According to Spearman's rank correlation coefficient and Friedman test, the age and gender of the patients had an insignificant correlation with the anesthetic effects of the four studied solutions. Conclusion: Based on these results, age and gender have insignificant effects on the pain scores and it can be said that the four solutions do not have significant differences regarding their anesthetic effects; also, we did not find any adverse reactions by using 7.5% and 10% lidocaine/prilocaine agent.

Pilot study on the influence of cold atmospheric plasma on bacterial contamination and healing tendency of chronic wounds.

Cold atmospheric plasma (CAP) has been used successfully for wound treatment, with thrice weekly treatment intervals. In this study, we wished to investigate whether comparably beneficial results can be achieved even with once weekly CAP treatment. In this randomized clinical pilot study (RCT) patients with therapy-refractory chronic wounds were examined over a maximum of twelve weeks. Groups1 and 2 were treated with CAP once and twice a week, respectively. Patients in Group3 received placebo therapy once a week. Wound area decreased significantly by 63.0% in Group1 (n = 14, P=0.005) and by 46.8% in Group2 (n=13, P=0.007). In Group3 (n=10) the wounds grew on average 17.5% larger. A significant reduction in pain was measured in both CAP-treated groups (Group1: P=0.042; Group2: P=0.027). Only in Group2 was there a significant improvement in wound-specific quality of life (P=0.005). After the 12-week CAP treatment, the reduction in bacterial load compared to the day of study inclusion averaged 50.4% for Group1 and 35.0% for Group2. Our RCT shows that treatment with CAP improves various aspects of wound healing in patients with therapy-refractory chronic wounds. The results obtained for once weekly treatment with CAP were not inferior to those obtained when CAP treatment was three times a week. Treatment once a week is also easier and more economical to implement in clinical routine.

Surgical treatment of peri-implantitis defects with two different xenograft granules: A randomized clinical pilot study.

ObjectivesTo investigate whether xenograft EB (EndoBon) is non‐inferior to xenograft BO (Bio‐Oss) when used in reconstructive surgery of peri‐implant osseous defects.Materials and methodsDental patients with one implant each demonstrating peri‐implantitis were randomized to receive surgical debridement and defect fill with either BO or EB. Changes in bone level (BL) and intrabony defect depth (IDD) evaluated radiographically were the primary outcomes. The secondary outcomes included changes in probing pocket depth (PPD), bleeding on probing (BoP), and suppuration on probing (SoP). All outcomes were recorded before treatment and at 6 and 12 months post‐treatment.ResultsTwenty‐four patients (n = 11 BO, n = 13 EB) completed the study. Both groups demonstrated significant within‐group improvements in all clinical and radiographic parameters at 6 and 12 months (p ≤ .001). At 12 months, both groups presented with IDD reductions of 2.5–3.0 mm on average. The inter‐group differences were not statistically significant at all time points and for all the examined parameters (p > .05). While the radiographic defect fill in both groups exceeded > 1 mm and can be considered treatment success, successful treatment outcomes as defined by Consensus Reporting (no further bone loss, PPD ≤ 5 mm, no BOP, and no SoP) were identified in 2/11 (18%) BO and 0/13 (0%) EB individuals (Fisher's exact test, p = .199).ConclusionsWithin the limitations of this pilot study, the application of xenograft EB showed to be non‐inferior to xenograft BO when used in reconstructive surgery of peri‐implant osseous defects.

Effect of melatonin administration on the PER1 and BMAL1 clock genes in patients with Parkinson’s disease

Sleep disorders are a widespread condition in patients with Parkinson's disease (PD), which has been linked to a deregulation of the circadian cycle and therefore of the clock genes. The aim of this study was to evaluate the effect of melatonin (MEL) on the PER1 and BMAL1 clock genes in patients with PD. A double-blind, cross-over, placebo-controlled randomized clinical trial pilot study was conducted in 26 patients with stage 1–3 PD according to the Hoehn & Yahr scale, who received either 25 mg of MEL or a placebo at noon and 30 min before bedtime for three months. The relative expression of the PER1 and BMAL1 genes was measured, as well as the presence of daytime, nocturnal, and global sleepiness, and the progression of PD. The levels of the PER1 and BMAL1 genes at baseline were 0.9 (0.1–3) vs. 0.56 (0.1−2.5), respectively; while after the intervention with MEL or placebo the BMAL1 levels increased to 2.5 (0−3.70) vs. 2.2 (0.10–3.30), respectively (d = 0.387). Fifty percent (50 %) of patients had daytime sleepiness and sixty-five percent (65 %) had abnormal nighttime sleepiness, yet neither group showed changes after the intervention. Patients with PD exhibited an alteration in the levels of the clock genes: MEL increased the levels of BMAL1, but the PER1 levels remained unchanged.

Use of a diabetes-specific nutritional shake to replace a daily breakfast and afternoon snack improves glycemic responses assessed by continuous glucose monitoring in people with type 2 diabetes: a randomized clinical pilot study

IntroductionThis pilot study evaluated the impact of a diabetes-specific nutritional shake (DSNS) used twice daily by people with type 2 diabetes (T2D) on glycemic response assessed by continuous glucose monitoring...

Evaluation and comparison of histologic changes and implant survival in extraction sites immediately grafted with two different xenografts: A randomized clinical pilot study

The purpose of this prospective, single-center randomized pilot study was to histologically evaluate and compare vital bone development in premolar and molar-extraction sites grafted with two different bovine-derived xenografts. The secondary outcome of interest was implant survival in the grafted sites. Adult patients in need of at least two tooth extractions were enrolled. A paired design was used; each patient received at least one of each type of graft at different sites. Each extraction site was randomized to one of two xenograft treatment groups. A resorbable membrane was always placed, and primary intention soft tissue closure was achieved. Four months later, implants were placed and a trephine drill was used to remove bone cores for histologic and histomorphometric analysis. Sixteen patients with 40 extraction sites were enrolled; 20 sites were grafted with one type of xenograft and 20 with another. Mean patient age was 53.5years, and 65% of patients were male. Evaluation of bone core samples taken from grafted sites showed no significant difference in the mean value of percentage of new bone formation between the different grafted sites (33.4% and 32.4%, p=.76). Cumulative implant survival was 97.5% at the 24-month follow-up visit. Within the limitations of this pilot study, no statistically significant differences in new bone growth between sites grafted with two different types of xenograft were found. Both graft materials promoted the formation of new bone and provided osseous support for implant placement after socket grafting.

Robotic Inguinal vs Transabdominal Laparoscopic Inguinal Hernia Repair

Despite rapid adoption of the robotic platform for inguinal hernia repair in the US, to date, no level I trials have ever compared robotic inguinal hernia repair to laparoscopic repair. This multicenter randomized clinical trial is the first to compare the robotic platform to laparoscopic approach for minimally invasive inguinal hernia repair. To determine whether the robotic approach to inguinal hernia repair results in improved postoperative outcomes compared with traditional laparoscopic inguinal hernia repairs. This multicenter, single-blinded, prospective randomized clinical pilot study was conducted from April 2016 to April 2019, with a follow-up duration of 30 days in 6 academic and academic-affiliated sites. Enrolled in this study were 113 patients with a unilateral primary or recurrent inguinal hernia. After exclusions 102 remained for analysis. Standard laparoscopic transabdominal preperitoneal repair or robotic transabdominal preperitoneal repair. Main outcomes included postoperative pain, health-related quality of life, mobility, wound morbidity, and cosmesis. Secondary outcomes included cost, surgeon ergonomics, and surgeon mental workload. A primary outcome was not selected because this study was designed as a pilot study. The hypothesis was formulated prior to data collection. A total of 102 patients were included in the study (54 in the laparoscopic group, mean [SD] age, 57.2 [13.3] years and 48 [88.9%] male; 48 in the robotic group, mean [SD] age, 56.1 [14.1] years and 44 [91.6%] male). There were no differences at the preoperative, 1-week, or 30-day points between the groups in terms of wound events, readmissions, pain as measured by the Visual Analog Scale, or quality of life as measured by the 36-Item Short Form Health Survey. Compared with traditional laparoscopic inguinal hernia repair, robotic transabdominal preperitoneal repair was associated with longer median (interquartile range) operative times (75.5 [59.0-93.8] minutes vs 40.5 [29.2-63.8] minutes, respectively; P < .001), higher median (interquartile range) cost ($3258 [$2568-$4118] vs $1421 [$1196-$1930], respectively; P < .001), and higher mean (SD) frustration levels on the NASA Task Load Index Scale (range, 1-100, with lower scores indicating lower cognitive workload) (32.7 [23.5] vs 20.1 [19.2], respectively; P = .004). There were no differences in ergonomics of the surgeons between the groups as measured by the Rapid Upper Limb Assessment instrument. Results of this study showed no clinical benefit to the robotic approach to straightforward inguinal hernia repair compared with the laparoscopic approach. The robotic approach incurred higher costs and more operative time compared with the laparoscopic approach, with added surgeon frustration and no ergonomic benefit to surgeons. ClinicalTrials.gov Identifier: NCT02816658.

Manual Therapy (Postisometric Relaxation and Joint Mobilization) in Knee Pain and Function Experienced by Patients with Rheumatoid Arthritis: A Randomized Clinical Pilot Study.

Objectives The purpose of this study was to evaluate the impact of manual therapy on the management of rheumatoid arthritis (RA) patients with knee pain. Materials and Methods This was a small, randomized clinical pilot study. Subjects were 46 patients with diagnosed RA, randomly assigned to the manual therapy group (postisometric relaxation and joint mobilization) or control group (standard exercise). Subjects in each group had 10 sessions of interventions, once a day with one day break after the sixth day. Outcomes included the pain intensity of knee, Knee Society Score, Oxford Knee Score, and Health Assessment Questionnaire. Results There were no statistically significant differences between groups, except for the pain intensity of the knee. Conclusions This study suggests that manual therapy (postisometric relaxation and joint mobilization) may have clinical benefits for treating knee pain and function in rheumatoid patients. Further extended studies are expected to determine the effectiveness of manual therapy in RA patients with knee pain.

Volumetric Analysis of Allogeneic and Xenogeneic Bone Substitutes Used in Maxillary Sinus Augmentations Utilizing Cone Beam Computed Tomography: A Prospective Randomized Pilot Study

The purpose of this prospective randomized clinical pilot study was to compare the three-dimensional changes of grafted maxillary sinuses when deproteinized bovine bone (DBB) or cortical mineralized allogeneic bone (MAB) was used. Seventeen patients were randomly assigned to receive either DBB or MAB for lateral-approach maxillary sinus augmentation. Cone beam computed tomography (CBCT) scans were performed preoperatively (T0), immediately after (T1), and at approximately 6 months posthoperatively (T2). Three-dimensional analysis of the radiographic volumetric changes was performed for DBB and MAB by measuring the difference in unoccupied sinus volumes at T1 and T2. In the DBB group, a statistically significant increase in unoccupied sinus volume was found at T2 when compared to T1 (P = .001). It represents a mean resorption rate of 23.8% ± 15.9%. Similarly in the MAB group, a statistically significant increase in unoccupied sinus volume was found at T2 when compared to T1 (P = .007). The mean resorption rate in the MAB group was 19.5% ± 10.1%. There was no statistically significant difference between the contraction of DBB (23.8%) and MAB (19.5%) (P = .52). Both DBB and MAB showed sufficient volume stability at T2 (mean 6.3 ± 1.6 months) postoperatively for 10- to 13-mm-implant placement without the need for additional grafting.

Microbiological dynamics of red complex bacteria following full-mouth air polishing in periodontally healthy subjects-a randomized clinical pilot study.

Suppression of periodontal pathogens in the oral cavity of periodontally healthy individuals may lower the risk for periodontal or periimplant diseases. Therefore, the present study aimed to analyze the effect of supragingival debridement (SD) with adjunctive full mouth glycine powder air polishing (FM-GPAP) on the prevalence of periodontal pathogens in periodontally healthy individuals. Eighty-seven systemically and periodontally healthy intraoral carriers of red complex bacteria, i.e., Porphyromonas gingivalis, Tannerella forsythia, and Treponema denticola or other periodontal pathogens including Aggregatibacter actinomycetemcomitans, Prevotella intermedia, and Eikenella corrodens were enrolled into the study and randomly assigned to receive SD with adjunctive FM-GPAP (test, n= 42) or SD alone (control, n = 45). In the first observation period, microbiological samples were obtained prior to, and 2, 5, and 9days following intervention. If one of these periodontal pathogens could still not be identified, additional microbial sampling was performed after 6 and 12weeks. The prevalence of red complex bacteria was significantly reduced in the test compared to the control group following treatment (p = 0.004) and at day 9 (p = 0.031). Intragroup comparison showed a significant (test, p < 0.001; control, p ≤ 0.01) reduction in the mean prevalence in both groups from BL through day 9 with an additional significant intergroup difference (p = 0.048) at day 9. However, the initial strong reduction returned to baseline values after 6 and 12weeks. In periodontally healthy carriers of periodontal pathogens, FM-GPAP as an adjunct to SD transiently enhances the suppression of red complex bacteria. Whether the enhanced suppression of red complex bacteria by adjunctive FM-GPAP prevents the development of periodontitis in periodontally healthy carriers requires further investigations.

Prevention of Low Cardiac Output Syndrome After Pediatric Cardiac Surgery: A Double-Blind Randomized Clinical Pilot Study Comparing Dobutamine and Milrinone.

Dobutamine and milrinone are commonly used after open-heart surgery to prevent or treat low cardiac output syndrome. We sought to compare efficacy and safety of these drugs in pediatric patients. Prospective, single-center, double-blinded, randomized clinical pilot study. Tertiary-care university children's hospital postoperative pediatric cardiac ICU. After written consent, 50 consecutive patients (age, 0.2-14.2 yr; median, 1.2 yr) undergoing open-heart surgery for congenital malformations were included. After cardiopulmonary bypass, a continuous infusion of either dobutamine or milrinone was administered for the first 36 postoperative hours. Maximum dose: dobutamine 6 µg/kg/min, milrinone 0.75 µg/kg/min. There were no significant differences in demographic data, complexity of surgery, and intraoperative characteristics between the two study groups (dobutamine vs milrinone). Efficacy was defined as need for additional vasoactive support, which did not differ between groups (dobutamine 61% vs milrinone 67%; p = 0.71). Sodium nitroprusside was used more often in the dobutamine group (42% vs 13%; p = 0.019). Systolic blood pressure showed a trend toward higher values in the dobutamine group, whereas both drugs increased heart rate early postoperatively. Echocardiography demonstrated a consistently good cardiac function in both groups. Central venous oxygen saturation, serum lactate levels, urine output, time to chest tube removal, length of mechanical ventilation, ICU, and hospital stay were similar in both groups. Both drugs were well tolerated, no serious adverse events occurred. Dobutamine and milrinone are safe, well tolerated, and equally effective in prevention of low cardiac output syndrome after pediatric cardiac surgery. The hemodynamic response of the two drugs is comparable. In uncomplicated cases, a trend toward the more cost-saving dobutamine might be anticipated; however, milrinone demonstrated a trend toward higher efficacy in afterload reduction.

Evaluation of central venous catheters coated with a noble metal alloy-A randomized clinical pilot study of coating durability, performance and tolerability.

The use of Central Venous Catheters (CVCs) commonly results in complications. Coatings with silver or metal alloys can reduce the risk associated with the use of CVC. We have evaluated the durability of a noble metal coated CVC (the Bactiguard Infectious Protection, BIP CVC) and compared with an uncoated CVC for clinical tolerability (Adverse Events, AEs) and performance, in order to create a baseline for a large future study. Patients undergoing major surgery, randomised at a 2:1 ratio to BIP CVC (n = 22) or standard CVC (n = 12), were catheterized 9 ‐ 12 days, respectively. Adverse events, microbial colonization and metal release were measured. Findings: There were no AEs in the BIP CVC‐group, but 5 AEs occurred in 4 patients (1 patient had 2 AEs) in the standard CVC‐group, p = 0.011 (whereof 3 were catheter related). The BIP CVC showed an initial release of coating metals in blood (gold, silver and palladium), which rapidly decreased and were far below Permitted Paily Exposure (PDE) for chronical use. The levels of silver concentration were far below those needed to develop microbial resistance. The performance was equal, and there was no difference concerning microbial colonization, for the two CVCs. Conclusion: In this pilot study the BIP CVC had significantly lower AEs and showed a comparable performance to the standard CVC. The coating was durable throughout the study length (up to 16 days) and toxicological evaluation showed good safety margins. Larger studies are needed. © 2017 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 106B: 2337–2344, 2018.

Interaction between chlorhexidine and fluoride in a mouthrinse solution—a 4-day and 6-week randomized clinical pilot study

The aim of the present investigation was to study if there is a reduced clinical effect and fluoride retention of a mouthrinse solution containing both chlorhexidine (CHX) and sodium fluoride (NaF). Two clinical trials were designed as double-blind, randomized, cross-over studies. In study I, 16 healthy subjects were asked to rinse twice daily for 1min during 4days of no tooth brushing with four solutions: (1) 0.12% CHX+0.2% NaF, (2) 0.2% NaF, (3) 0.12% CHX, and (4) placebo. In study II, another 16 healthy subjects rinsed with the same four solutions twice daily after tooth brushing during a 6-week period. Plaque formation, gingivitis, and microbiological samples from plaque and saliva, as well as fluoride retention, were analyzed. Both studies showed that both CHX+NaF and CHX mouthrinses had the same clinical effect with regards to plaque formation and microflora in plaque and saliva. Similarly, fluoride retention was not altered by the CHX+NaF mouthrinse compared to the NaF solution. The combination of CHX and NaF in a mouthrinse showed the same clinical effect as the CHX solution. The retention of fluoride in the oral cavity was not affected by the combination of NaF and CHX. A mouthrinse solution containing a mixture of CHX and NaF may be an interesting product for risk patients for caries and periodontal disease. However, this should be verified in further long-term clinical studies.

Early skin-to-skin contact after cesarean section: A randomized clinical pilot study.

ObjectiveEarly bonding by skin-to-skin contact (SSC) has been demonstrated to be beneficial for mothers and newborns following vaginal delivery. The aim of this study was to investigate the impact of intraoperative bonding (early SSC) after cesarean section on neonatal adaptation, maternal pain and stress response.Study designThis prospective, randomized-controlled pilot study was performed at a single academic tertiary hospital (Department of Obstetrics and Gynecology, Medical University of Graz, Austria) between September 2013 and January 2014. Women were randomly assigned to intraoperative (“early”) SCC (n = 17) versus postoperative (“late”) SCC (n = 18). Main variables investigated were neonatal transition (Apgar score, arterial oxygen saturation, heart rate and temperature), maternal pain perception and both maternal and neonatal stress response by measuring the stress biomarkers salivary free cortisol and salivary alpha amylase.ResultsThere was no evidence for differences in parameters reflecting neonatal transition or stress response between the ‘Early SSC Group’ and the ‘Late SSC Group’. Maternal salivary cortisol and alpha-amylase levels as well as maternal wellbeing and pain did not differ between the groups. However, the rise of maternal salivary alpha-amylase directly after delivery was higher in the ‘Early SSC Group’ compared to the ‘Late SSC Group’ (p = 0.004).ConclusionsThis study did not reveal significant risks for the newborn in terms of neonatal transition when early SSC is applied in the operating room. Maternal condition and stress marker levels did not differ either, although the rise of maternal salivary alpha-amylase directly after delivery was higher in the ‘Early SSC Group’ compared to the ‘Late SSC Group’, which may indicate a stressor sign due to intensive activation of the sympathetic-adreno-medullary-system. This needs to be further evaluated in a larger prospective randomized trial.Trial registrationClinicalTrials.gov NCT01894880

Comparison of Deep Tissue Massage and Therapeutic Massage for Lower Back Pain, Disease Activity, and Functional Capacity of Ankylosing Spondylitis Patients: A Randomized Clinical Pilot Study.

Objectives This study aims to compare the effectiveness of deep tissue massage (DTM) and therapeutic massage (TM) in the management of ankylosing spondylitis (AS) patients. Materials and Methods This was a small, randomized clinical pilot study. Subjects were 27 men with diagnosed AS, randomly assigned to DTM group or TM group. Subjects in each group had 10 sessions of massage. Outcomes included the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), the Bath Ankylosing Spondylitis Functional Index (BASFI), Modified Schober Test, Finger to Floor Test, chest expansion, and pain intensity of lower back. Results There are no statistical significant differences between groups, except for BASDAI and pain intensity of lower back. Conclusions This study suggests that massage may have clinical benefits for treating ankylosing spondylitis patients. Additional scientific research in this area is warranted.