scholarly journals Advantages of Porcine Xenograft over Autograft in Sinus Lift: A Randomised Clinical Trial

Materials ◽  
2021 ◽  
Vol 14 (12) ◽  
pp. 3439
Author(s):  
Francisco Correia ◽  
Daniel Humberto Pozza ◽  
Sónia Gouveia ◽  
António Campos Felino ◽  
Ricardo Faria Almeida
Keyword(s):  
Bone Biopsy ◽  
Controlled Trial ◽  
Randomised Clinical Trial ◽  
Ct Scans ◽  
Sinus Lift ◽  
Bone Level ◽  
Autologous Bone ◽  
Autologous Bone Grafts ◽  
Randomised Controlled ◽  
Porcine Xenograft

This study aimed to compare the performance of intra-oral autologous bone grafts versus porcine xenografts in a two-step lateral window sinus lift. This split-mouth randomised controlled trial sequentially enrolled 12 patients with a 6-month follow-up. For each patient, a simultaneous randomised bilateral maxillary sinus lift was performed and filled with autologous bone from the mandible (control) or a porcine xenograft (test). A bone biopsy sample was collected during the implant placement for histological and histomorphometric analysis. CT scans were performed at the beginning and at the end of the trial to assess radiological evolution. A comparison of initial and six-month CT scans indicated statistically significant increases in bone level for both materials (7.8 ± 2.4 mm for autologous and 8.7 ± 2.2 mm for xenograft, p < 0.05), and there were no significant differences between the performance of the two materials over time (p = 0.26). The histological analysis showed various stages of the remodelling process and no cells or other signs of inflammation or infection were visible in both groups. The porcine xenografts presented similar results for the studied variables when compared to autologous bone, being a reasonable alternative for a sinus lift.

scholarly journals Can topical epinephrine application to the papilla prevent pancreatitis after endoscopic retrograde cholangiopancreatography? Results from a double blind, multicentre, placebo controlled, randomised clinical trial

2021 ◽  
Vol 8 (1) ◽  
pp. e000562
Author(s):  
Adriana Fabiola Romano-Munive ◽  
J Jesus García-Correa ◽  
Luis F García-Contreras ◽  
José Ramírez-García ◽  
Luis Uscanga ◽  
...  
Keyword(s):  
Endoscopic Retrograde Cholangiopancreatography ◽  
Controlled Trial ◽  
Randomised Clinical Trial ◽  
Sterile Water ◽  
Endoscopic Retrograde ◽  
Double Blind ◽  
Registration Number ◽  
Baseline Characteristics ◽  
Randomised Controlled ◽  
Rectal Indomethacin

Background and study aimsPost-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) is a complication associated with important morbidity, occasional mortality and high costs. Preventive strategies are suboptimal as PEP continues to affect 4% to 9% of patients. Spraying epinephrine on the papilla may decrease oedema and prevent PEP. This study aimed to compare rectal indomethacin plus epinephrine (EI) versus rectal indomethacin plus sterile water (WI) for the prevention of PEP.Patients and methodsThis multicentre randomised controlled trial included patients aged >18 years with an indication for ERCP and naive major papilla. All patients received 100 mg of rectal indomethacin and 10 mL of sterile water or a 1:10 000 epinephrine dilution. Patients were asked about PEP symptoms via telephone 24 hours and 7 days after the procedure. The trial was stopped half way through after a new publication reported an increased incidence of PEP among patients receiving epinephrine.ResultsOf the 3602 patients deemed eligible, 3054 were excluded after screening. The remaining 548 patients were randomised to EI group (n=275) or WI group (n=273). The EI and WI groups had similar baseline characteristics. Patients in the EI group had a similar incidence of PEP to those in the WI group (3.6% (10/275) vs 5.12% (14/273), p=0.41). Pancreatic duct guidewire insertion was identified as a risk factor for PEP (OR 4.38, 95% CI (1.44 to 13.29), p=0.009).ConclusionSpraying epinephrine on the papilla was no more effective than rectal indomethacin alone for the prevention of PEP.Trial registration numberThis study was registered with ClinicalTrials.gov (NCT02959112).

scholarly journals Maximising trichiasis surgery success (MTSS) trial: rationale and design of a randomised controlled trial to improve trachomatous trichiasis surgical outcomes

BMJ Open ◽  
2020 ◽  
Vol 10 (3) ◽  
pp. e036327 ◽  
Author(s):  
Belay Bayissasse ◽  
Kristin M Sullivan ◽  
Shannath L Merbs ◽  
Beatriz Munoz ◽  
Alexander Keil ◽  
...  
Keyword(s):  
Surgical Outcomes ◽  
Controlled Trial ◽  
Randomised Clinical Trial ◽  
Upper Eyelid ◽  
Intention To Treat ◽  
Research Ethics Review ◽  
Registration Number ◽  
Randomised Controlled ◽  
The Impact ◽  
Trachomatous Trichiasis

IntroductionTrachomatous trichiasis (TT) is a condition in which the eyelid turns inward and eyelashes abrade the front part of the eye. To prevent eventual blindness, surgery is recommended. Two surgical procedures are commonly used, bilamellar tarsal rotation (BLTR) and posterior lamellar tarsal rotation (PLTR). Evidence suggests that incision height and surgery type may affect the risk of postoperative TT (PTT) and other surgical outcomes. However, these studies have not prospectively compared the impact of incision height on surgical outcomes.Methods and analysisMaximising trichiasis surgery Success (MTSS) is a three-arm, randomised clinical trial being conducted in Ethiopia. Participants will be randomly assigned on a 1:1:1 basis to BLTR with a 3 mm incision height, BLTR with a 5 mm incision height, or PLTR 3 mm incision height. Patients are eligible for the trial if they have previously unoperated upper eyelid TT. Follow-up visits will be conducted by trained eye examiners at 1 day, 2 weeks, 6 weeks and 12 months after surgery. The primary outcome is incident PTT within 1 year following surgery. Logistic regression will be used in an intention-to-treat analysis to assess outcome incidence by surgical approach.Ethics and disseminationThe University of North Carolina and Johns Hopkins School of Medicine institution review boards, Ethiopian National Research Ethics Review Committee and Ethiopian Food, Medicine, Healthcare and Administration and Control Authority provided ethics approval for the trial. On completion, trial results will be disseminated at local and international meetings and in peer-reviewed journals.Trial registration numberNCT03100747.

scholarly journals A randomised clinical trial of ultrasound guided cannulation of difficult fistulae for dialysis access

2020 ◽  
pp. 112972982095472
Author(s):  
Joshua Eves ◽  
Paris Cai ◽  
Ross Latham ◽  
Clement Leung ◽  
Daniel Carradice ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Ultrasound Guidance ◽  
Controlled Trial ◽  
Standard Technique ◽  
Randomised Clinical Trial ◽  
Dialysis Access ◽  
Complication Rates ◽  
Ultrasound Guided ◽  
Prolonged Time ◽  
Randomised Controlled

Background: Arteriovenous fistulae (AVF) are preferred for dialysis access but require accurate cannulation for effective dialysis. Evidence supports improvements in cannulation and complication rates using ultrasound guidance (USG) in cannulating other sites. This mixed methods, randomised controlled trial aimed to assess effects of USG during AVF cannulation. Methods: Participants with difficult to cannulate AVF had each cannulation event randomised to USG or standard technique (no USG). The primary outcome was the incidence and number of additional needle passes. Secondary outcomes included: the incidence and number of additional skin punctures; time to achieve two needle cannulation; pain associated with cannulation; local complications. Qualitative outcomes were assessed using patient and staff questionnaires. Results: Thirty-two participants had 346 cannulation events randomised (170 to USG and 176 to standard cannulation). USG resulted in a significant reduction in additional needle passes (72 vs 99 p = 0.007) and additional skin punctures (10 vs 25 p = 0.016.) but prolonged time to cannulation ( p > 0.001). There was no difference in pain score ( p = 0.705) or complications between groups. Questionnaires demonstrated that USG cannulation is acceptable to patients and staff. Conclusion: USG cannulation of AVF is more accurate and no more painful than non-image guided cannulation, but prolonged time to cannulation. Some of the excess time involved may be due to the trial being performed early in cannulating staff’s learning curve with the USG technique. Further work to elucidate which patients gain most benefit from USG cannulation and the effect of USG on cannulation complications and AVF patency is warranted.

scholarly journals Group psychoeducation for stabilised bipolar disorders: 5-year outcome of a randomised clinical trial

2009 ◽  
Vol 194 (3) ◽  
pp. 260-265 ◽  
Author(s):  
F. Colom ◽  
E. Vieta ◽  
J. Sánchez-Moreno ◽  
R. Palomino-Otiniano ◽  
M. Reinares ◽  
...  
Keyword(s):  
Group Intervention ◽  
Psychological Intervention ◽  
Controlled Trial ◽  
Bipolar Disorders ◽  
Randomised Clinical Trial ◽  
Median Number ◽  
Group Psychoeducation ◽  
Randomised Controlled

BackgroundThe long-term efficacy of psychological interventions for bipolar disorders has not been tested.AimsThis study assessed the efficacy of group psychoeducation to prevent recurrences and to reduce time spent ill for people with bipolar disorders.MethodA randomised controlled trial with masked outcome assessment comparing group psychoeducation and non-structured group intervention during 5-year follow-up. One hundred and twenty people with bipolar disorders were included in the study and 99 completed 5-year follow-up. Time to any recurrence, number of recurrences, total number of days spent ill, frequency and length of hospitalisations were the main outcome measures.ResultsAt the 5-year follow-up, time to any recurrence was longer for the psychoeducation group (log rank=9.953, P<0.002). The psychoeducation group had fewer recurrences (3.86 v. 8.37, F=23.6, P<0.0001) of any type and they spent less time acutely ill (154 v. 586 days, F=31.66, P=0.0001). The median number of days of hospitalisation per hospitalised participant was also lower for the psychoeducation group (45 v. 30, F=4.26, P=0.047).ConclusionsSix-month group psychoeducation has long-lasting prophylactic effects in individuals with bipolar disorders. Group psychoeducation is the first psychological intervention showing such a long-term maintained efficacy in people with bipolar disorders.

scholarly journals Alternative Caries Management Options for Primary Molars: 2.5-Year Outcomes of a Randomised Clinical Trial

2017 ◽  
Vol 51 (6) ◽  
pp. 605-614 ◽  
Author(s):  
Ruth M. Santamaría ◽  
N.P.T. Innes ◽  
Vita Machiulskiene ◽  
Julian Schmoeckel ◽  
Mohammad Alkilzy ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Survival Rates ◽  
Randomised Clinical Trial ◽  
Primary Molars ◽  
Management Options ◽  
Kaplan Meier ◽  
Significant Difference ◽  
Caries Management ◽  
Caries Removal ◽  
Randomised Controlled

Less invasive caries management techniques for treating cavitated carious primary teeth, which involve the concept of caries control by managing the activity of the biofilm, are becoming common. This study aimed to compare the clinical efficacy (minor/major failures) and survival rates (successful cases without any failures) of 3 carious lesion treatment approaches, the Hall Technique (HT), non-restorative caries treatment (NRCT), and conventional restorations (CR), for the management of occlusoproximal caries lesions (ICDAS 3-5) in primary molars. Results at 2.5 years are presented. A total of 169 children (3- to 8-year-olds) were enrolled in this secondary care-based, 3-arm parallel-group, randomised controlled trial. Participants were allocated to: HT (n = 52; sealing caries with stainless-steel crowns without caries removal), NRCT (n = 52; opening up the cavity and applying fluoride varnish), CR (n = 65; control arm, complete caries removal and compomer restoration). Statistical analyses were: non-parametric Kruskal-Wallis analysis of variance, Mann-Whitney U test and Kaplan-Meier survival analyses. One hundred and forty-two participants (84%; HT = 40/52; NRCT = 44/52; CR = 58/65) had follow-up data of 1-33 months (mean = 26). Overall, 25 (HT = 2, NRCT = 9, CR = 14) of 142 participants (17.6%) presented with at least 1 minor failure (reversible pulpitis, caries progression, or secondary caries; p = 0.013, CI = 0.012-0.018; Mann-Whitney U test). Ten (HT = 1, NRCT = 4, CR = 5) of 142 participants (7.04%) experienced at least 1 major failure (irreversible pulpitis, abscess, unrestorable tooth; p = 0.043, CI = 0.034-0.045). Independent comparisons between 2 samples found that NRCT-CR had no statistically significant difference in failures (p > 0.05), but for CR-HT (p = 0.037, CI = 0.030-0.040) and for NRCT-HT (p = 0.011, CI = 0.010-0.016; Kruskal-Wallis test) significant differences were observed. Cumulative survival rates were HT = 92.5%, NRCT = 70.5%, and CR = 67.2% (p = 0.012). NRCT and CR outcomes were comparable. HT performed better than NRCT and CR for all outcomes. This study was funded by the Paediatric Dentistry Department, Greifswald University, Germany (Trial registration No. NCT01797458).

CRESTAL VERSUS LATERAL SINUS LIFT: ONE-YEAR RESULTS FROM A WITHIN PATIENT RANDOMISED CONTROLLED TRIAL

2020 ◽  
Vol 01 (01) ◽  
pp. 67
Author(s):  
E. Xhanari ◽  
M. Tallarico ◽  
S.M. Meloni ◽  
Z. Kalemaj ◽  
F.M. Ceruso ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Lateral Sinus ◽  
Sinus Lift ◽  
One Year ◽  
Randomised Controlled

Sustained Wellbeing Benefits of Red Meat Consumption in a Modern Flexitarian Diet: A Study Protocol for a 10 Week Randomised Clinical Trial (Preprint)

2021 ◽  
Author(s):  
Andrea Braakhuis ◽  
David Cameron-Smith ◽  
Scott Knowles ◽  
Tamlin Connor ◽  
Rajshri Roy ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Fatty Acid Distribution ◽  
Randomised Clinical Trial ◽  
Red Meat ◽  
Post Intervention ◽  
Animal Products ◽  
Balanced Diet ◽  
Assessment Period ◽  
Randomised Controlled

UNSTRUCTURED Background The trend of flexitarian eating patterns is on the rise, with young adults amongst the biggest adopters claiming health and environmental reasons to reduce red meat intake. Nutrient dense meat and animal products are often the lynchpin of these diets, even when consumed only occasionally and in moderate amounts. Red meat provides forms and concentrations of essential proteins, lipids, and micronutrients that are scarce in exclusively vegetarian regimens. Objective The aim of this investigation is to consider the effects of moderate consumption of lean red meat as part of an otherwise vegetarian balanced diet and its impact on biomarkers of sustained health and wellbeing. Methods A cohort of healthy, young (20-34 years) male and female participants will take part in two-arm parallel, randomised-controlled trial for a duration of 12 weeks, with a 3-month post follow-up. The trial will commence with a two-week assessment period followed by allocation to the intervention arms. The intervention will include the consumption of red meat or meat-alternatives three times per week for 10 weeks. Blood samples of the participants will be measured for changes in erythrocyte fatty acid distribution, circulating amino acids, neurotransmitters, markers of mineral status and inflammatory markers. Questionnaires to assess wellbeing and mental health will be undertaken every two weeks. Body composition, physical function test, blood measurements will be assessed at allocation (t0), week five into the intervention (t5) and post intervention (t10). Discussion To our knowledge this is the first randomised controlled trial (RCT) investigating the overarching health consequences of consuming NZ pasture fed red meat or no meat, as part of a healthy diet.

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