Clinical safety of enamel matrix derivative (EMDOGAIN®) in the treatment of periodontal defects

Abstract The aim of the present clinical trial was to test tolerability during 2 treatments with EMDOGAIN® in a large number of patients. An open, controlled study design in 10 Swedish specialist clinics was chosen, with a test group of 107 patients treated with EMDOGAIN® in connection with periodontal surgery at 2 surgical test sites per patient. The procedures were performed 2 to 6 weeks apart on one-rooted teeth with at least 4 mm deep intraosseous lesions. A control group of 33 patients underwent flap surgery without EMDOGAIN® at I comparable site. In total 214 test and 33 control surgeries were performed. Serum samples were obtained from test patients for analysis of total and specific antibody levels. 10 of the patients had samples taken before and after the first surgery. 56 other samples were taken after one treatment with EMDOGAIN®, and 63 after 2 treatments. None of the samples, not even from allergy-prone patients after 2 treatments, indicated deviations from established baseline ranges. This indicates that the immunogenic potential of EMDOGAIN® is extremely low when applied in conjunction with periodontal surgery. Comparison between the test and control groups demonstrated the same type and frequency of post-surgical experiences, i.e., reactions caused by the surgical procedure itself. Clinical probing and radiographic evaluation was performed at baseline and 8 months postsurgery. About half of the patients (44 test and 21 control) were also evaluated after 3 years. There was a significant difference between the test and control results at 8 months post surgery. and this difference had increased further at the 3 year follow-up. The 2.5–3 mm increase in attachment and bone level after treatment with EMDOGAIN® was of the same magnitude as seen in the studies with split-mouth design aiming for lest of effectiveness of EMDOGAIN®.     

Hemoderivative Transfusion in Liver Transplantation: Comparison Between Recipients of Grafts From Brain Death Donors and Recipients of Uncontrolled Donors After Circulatory Death

IntroductionIntraoperative bleeding during liver transplantation has been correlated with a higher risk of morbidity and mortality and decrease in patient and graft survival.Materials and MethodsBetween January 2006 and December 2016 we performed 783 orthotopic liver transplants. After applying exclusion criteria, we found liver grafts from donors after circulatory death (DCD, group A) were used in 69 patients and liver grafts from donors after brain death (group B) were used in 265 patients.ResultsNo difference was found in terms of sex, body mass index, Model for End-Stage Liver Disease score, indication for transplantation, intensive care unit stay, and Child-Pugh score. The mean transfusion of hemoderivates was as follows: red blood cell 9 (0-28) units in group A vs 6 (0-20) units in group B (P = .004) and fresh frozen plasma 10 (0-29) units in group A vs 9.5 (0-23) in group B (P = .000). The only 2 factors related to massive blood transfusion (>6 units of red blood cell) were uncontrolled DCD condition (odds ratio = 2.38; 95% confidence interval, 1.32-4.31; P = .004), and higher Model for End-Stage Liver Disease score (odds ratio = 2.63; 95% confidence interval, 1.53-4.55; P = .001). Survival at 1, 3, and 5 years was 81.3%, 70.2%, and 68.9% in group A vs 89%, 83.7%, and 78% in group B (P = .070).ConclusionThe use of liver grafts from DCDs is associated with increased necessity of transfusion of hemoderivates in comparison with the use of liver grafts from donors after brain death.     

Pharmacodynamics of Phenobarbital Anesthesia and Pentylenetetrazol-Induced Maximal Seizures in a Rat Model of Neoplastic Spinal Cord Compression

The purpose of this investigation was to determine whether paraplegia induced by neoplastic cord compression affects the pharmacodynamics of phenobarbital general anesthesia or of pentylenetet-razol (PTZ)-induced convulsions. Paraplegic rats harboring a thora-columbar epidural tumor, or an identical hindlimb tumor mass, received an i.v. infusion of phenobarbital until the onset of anesthesia. At that point, the phenobarbital concentrations in the CSF and serum were measured. Similarly, PTZ was infused until the onset of maximal seizures. It was found that changes related to systemic tumor growth and newly developed paraplegia due to neoplastic spinal cord compression did not attenuate the pharmacodynamics of phenobarbital. However, sustained paraplegia of 4 days duration reduced CNS sensitivity to the hypnotic action of the barbiturate as evidenced by the higher cerebrospinal fluid phenobarbital concentration required to induce anesthesia (170 ± 31 vs 125 ± 20 mg/L; P < 0.05). On the other hand, sustained paraplegia did not affect brain threshold concentration for PTZ-induced seizures.     

“They silently live in terror…” why sleep problems and night-time related quality-of-life are missed in children with a fetal alcohol spectrum disorder

Children and adolescents with a Fetal Alcohol Spectrum Disorder (FASD) are at high-risk for developing sleep problems (SPs) triggering daytime behavioral co-morbidities such as inattention, hyperactivity, and cognitive and emotional impairments. However, symptoms of sleep deprivation are solely associated with typical daytime diagnosis, such as attention deficit hyperactivity disorder (ADHD) and treated with psychotropic medications. To understand how and why SPs are missed, we conducted qualitative interviews (QIs) with six parents and seven health care professionals (HCPs), and performed comprehensive clinical sleep assessments (CCSAs) in 27 patients together with their caregivers referred to our clinic for unresolved SPs. We used narrative schema and therapeutic emplotment in conjunction with analyzes of medical records to appropriately diagnose SPs and develop treatment strategies. The research was conducted at British Columbia Children's Hospital in Vancouver (Canada) between 2008 and 2011. In the QIs, parents and HCPs exhibited awareness of the significance of SPs and the effects of an SP on the daytime behaviors of the child and the associated burdens on the parents. HCPs' systemic inattention to the sequelae of SPs and the affected family's wellbeing appears due to an insufficient understanding of the various factors that contribute to nighttime SPs and their daytime sequelae. In the CCSAs, we found that the diagnostic recognition of chronic SPs in children and adolescents was impaired by the exclusive focus on daytime presentations. Daytime behavioral and emotional problems were targets of pharmacological treatment rather than the underlying SP. Consequently, SPs were also targeted with medications, without investigating the underlying problem. Our study highlights deficits in the diagnostic recognition of chronic SPs among children with chronic neurodevelopmental disorders/disabilities and proposes a clinical practice strategy, based on therapeutic emplotment that incorporates patients and parents' contributions in recognizing SPs and related sequelae in designing appropriate treatment and care.     

A mixed method evaluation of a group‐based educational programme for CPAP use in patients with obstructive sleep apnea

Rationale, aims and objectives Continuous positive airway pressure (CPAP) treatment of obstructive sleep apnea (OSA) has a low long‐term adherence. Educational interventions are few and sparsely described regarding content, pedagogical approach and participants' perceptions. The aim was to describe adherence to CPAP treatment, knowledge about OSA/CPAP, as well as OSA patients' perceptions of participating in a group‐based programme using problem‐based learning (PBL) for CPAP initiation. Educational programme The PBL programme incorporated elements from theories and models concerning motivation and habits. Tutorial groups consisting of four to eight patients met at six sessions during 6 months. Methods A sequential explanatory mixed method design was used on 25 strategically selected patients. Quantitative data regarding, clinical variables, OSA severity, CPAP use, and knowledge were collected at baseline, after 2 weeks and 6 months. Qualitative data regarding patients' perceptions of participation were collected after 6 months by semi‐structured interviews using a phenomenographic approach. Results 72% of the patients were adherent to CPAP treatment after 2 weeks and 6 months. All patients improved their baseline knowledge about OSA and CPAP after 2 weeks and sustained it after 6 months. Anxiety and fear, as well as difficulties and needs were motivational factors for participation. Patients described the difficulties of behavioural change, an awareness that improvements do not occur immediately, a realization of the importance of both technical and emotional support and the need for a healthier lifestyle. Conclusion and practice implications A group‐based programme using PBL seems to facilitate adaptive and developmental learning and result in acceptable CPAP adherence levels.