A split-mouth randomized controlled trial to compare the rate of canine retraction after a soft tissue procedure compared against a corticotomy procedure for accelerated tooth movement.

Background and Aim: Various methods to accelerate the orthodontic tooth movement have been used, among which corticotomy is considered to be the most common one. The suggested reasoning for such acceleration was the regional acceleratory phenomenon (RAP). Since the RAP is a property of both the hard and soft tissues, we designed a soft tissue flap procedure to compare the effects with the conventional corticotomy procedure. A split-mouth study was conducted where the two procedures were assessed in a single participant. Patients and Methods: The total sample size was calculated to be 40 with 20 participants in each group. The rate of tooth movement was the primary outcome measure, and the secondary outcomes were dentoalveolar changes, which were studied in both the conventional corticotomy and the flap-only procedure based on a cone-beam computed tomography (CBCT) wherein the alveolar bone density (BD) around canines, tipping, and rotational changes in canines, premolars, and molars were assessed. Results: Corticotomy resulted in greater canine angulation, lesser canine rotation and premolar rotation, and greater molar rotation compared with flap elevation, but these differences were statistically insignificant. Conclusion: Though the corticotomy resulted in higher BD, the differences were statistically insignificant. There was no significant difference in the rate of space closure assessed by the two techniques compared.

Sotrastaurin in calcineurin inhibitor-free regimen using everolimus in de novo kidney transplant recipients.

Sotrastaurin, a novel selective protein-kinase-C inhibitor, inhibits early T cell activation via a calcineurin-independent pathway. Efficacy and safety of sotrastaurin in a calcineurin inhibitor-free regimen were evaluated in this two-stage Phase II study of de novo kidney transplant recipients. Stage 1 randomized 131 patients (2:1) to sotrastaurin 300 mg or cyclosporine A (CsA). Stage 2 randomized 180 patients (1:1:1) to sotrastaurin 300 or 200 mg or CsA. All patients received basiliximab, everolimus (EVR) and prednisone. Primary endpoint was composite efficacy failure rate of treated biopsy-proven acute rejection, graft loss, death or lost to follow-up. Main safety assessment was estimated glomerular filtration rate (eGFR) by MDRD-4 at Month 12. Composite efficacy failure rates at 12 months were higher in sotrastaurin arms (Stage 1: 16.5% and 10.9% for sotrastaurin 300 mg and CsA; Stage 2: 27.2%, 34.5% and 19.4% for sotrastaurin 200 mg, 300 mg and CsA). eGFR was significantly better in sotrastaurin groups versus CsA at most time points, except at 12 months. Gastrointestinal and cardiac adverse events were more frequent with sotrastaurin. Higher treatment discontinuation, deaths and graft losses occurred with sotrastaurin 300 mg. Sotrastaurin combined with EVR showed higher efficacy failure rates and some improvement in renal allograft function compared to a CsA-based therapy.