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- Gualini, F., et al.
(författare)
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Subcrestal placement of dental implants with an internal conical connection of 0.5 mm versus 1.5 mm: Outcome of a multicentre randomised controlled trial 1 year after loading
- 2017
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Ingår i: European Journal of Oral Implantology. - 1756-2406. ; 10:1, s. 73-82
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Tidskriftsartikel (refereegranskat)abstract
- Purpose: To evaluate whether there are some clinical benefits by placing single dental implants either 0.5 or 1.5 mm subcrestally in healed bone crests. Materials and methods: Sixty partially edentulous patients requiring two single implant-supported crowns had both sites randomly allocated either to 0.5 mm or 1.5 mm subcrestal implant placement according to a split-mouth design at six centres. Implants were submerged in aesthetic areas or nonsubmerged in non-aesthetic areas for 3 months. Provisional acrylic crowns were delivered and were replaced after 2 months by definitive metal-ceramic crowns. Patients were followed to 1 year after loading. Outcome measures were: crown and implant failures; complications; aesthetics assessed using the pink esthetic score (PES); peri-implant marginal bone level changes; and patient preference, recorded by blinded assessors. Results: One patient dropped out. One patient lost both implants to infection at impression taking. Three complications affected three patients of the 0.5 mm group and two complications affected two patients of the 1.5 mm subcrestally placed implants. One patient had complications at both implants. There were no statistically significant differences for complications between group (difference of proportion = 0.02; 95% Cl-0.06 to 0.09; P (McNemar test) = 1.000). At delivery of definitive crowns, 2 months after loading, the mean aesthetic score was 11.22 +/- 1.91 and 11.12 +/- 1.59 for the 0.5 and 1.5 mm group, respectively. At 1 year after loading, the mean aesthetic score was 12.09 +/- 1.66 and 12.10 +/- 1.52 for the 0.5 and 1.5 mm group, respectively. There were no statistically significant differences between the two groups at 2 months (P (paired t test) = 0.626) or at 1 year (P (paired t test) = 0.920). One year after loading, patients of the 0.5 mm lost on average 0.21 +/- 0.51 mm and those of the 1.5 mm group 0.11 +/- 0.36 mm, the difference being not statistically significant (difference = 0.10; 95% Cl-0.01 to 0.20; P (paired t test) = 0.078). Patients did not prefer any depth of the implant placement over the other. There were no differences in outcomes between centres. Conclusions: No statistical or clinical differences were noticed when placing implants 0.5 mm or 1.5 mm subcrestally therefore clinicians can do as they prefer.
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| 2. |
- Kraemer, B. K., et al.
(författare)
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Efficacy of Prolonged- and Immediate-release Tacrolimus in Kidney Transplantation : A Pooled Analysis of Two Large, Randomized, Controlled Trials
- 2017
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Ingår i: Transplantation Proceedings. - : Elsevier BV. - 0041-1345 .- 1873-2623. ; 49:9, s. 2040-2049
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Tidskriftsartikel (refereegranskat)abstract
- Background. Two large, prospective studies (12-03; OSAKA) compared the efficacy and tolerability of prolonged-release versus immediate-release tacrolimus in kidney transplant patients also receiving mycophenolate mofetil and low-dose corticosteroids (without induction therapy). Methods. Data were combined into one database to compare results over 24 weeks using 3 alternative endpoints: biopsy-confirmed acute rejection (BCAR); the Food and Drug Administration composite endpoint (graft loss, SCAR, and loss to follow-up), and the European Medicines Agency composite endpoint (graft loss, BCAR, and graft dysfunction). The 95% confidence intervals were calculated (10% noninferiority margin). Results. Overall, 633 patients received prolonged-release tacrolimus (12-03, n = 331; OSAKA, n = 302) and 645 received immediate-release tacrolimus (n = 336; n = 309). Baseline characteristics were comparable. Proportionately more patients receiving prolonged-release tacrolimus had trough levels of 5-15 ng/mL on day 1 (60.8%) and 2 (56.6%) versus immediate-release tacrolimus (42.5% and 43.9%, respectively, both P < .001). Efficacy of prolonged-release and immediate-release tacrolimus were similar as assessed by BCAR (13.9% vs 14.1%, respectively), European Medicines Agency composite endpoint (40.3% vs 38.3%) and US Food and Drug Administration composite endpoint (21.5% vs 19.8%). Conclusions. Novel efficacy endpoints as required by the European Medicines Agency and US Food and Drug Administration demonstrate noninferiority of prolonged-release versus immediate-release tacrolimus. Significantly more patients treated with prolonged release tacrolimus versus immediate-release tacrolimus achieved trough levels of 5 to 15 ng/mL early after transplantation.
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