Randomised clinical trial investigating self-assembling peptide P11-4 in the treatment of early caries.

OBJECTIVES: This prospective, randomised, split-mouth, clinical trial compared the efficacy of the self-assembling peptide P11-4 to fluoride varnish in the treatment of early buccal carious lesions. MATERIALS AND METHODS: Subjects presenting at least two clinically affected teeth were treated at D0 (day 0) and D90 with P11-4 (test) or fluoride varnish (control). At D180, fluoride varnish was applied on all study lesions. Standardised photographs were taken at D0, D30, D90, D180 and D360 and blindly morphometrically assessed. Hierarchical linear models (HLM) under allowance of confounders were used to compare the decrease in size between test and control groups. The visual analog scale (VAS) and Global Impression of Change Questionnaire (GICQ) were used as clinical assessments. RESULTS: Overall, 37 subjects (13-36 years) with 90 early carious lesions were included. HLM analysis showed a significant difference between test and control groups, indicating a decrease in test lesions and stabilisation of control lesions size (p = 0.001). The test lesion's mean size (SD) relative to baseline decreased to D30 = 0.936(0.127), D90 = 0.874(0.173), D180 = 0.844(0.215) and D360 = 0.862(0.352), whereas control lesions remained stable at D30 = 1.018(0.209), D90 = 1.013(0.207), D180 = 1.029(0.235) and D360 = 1.068(0.401). The effect sizes ranged from 0.47 to 0.82. CONCLUSIONS: Within the limits of this study, it was shown that the size of early carious lesions treated with P11-4 was significantly reduced; this result was superior to that of fluoride varnish treatment (DRKS00012941). CLINICAL RELEVANCE: The self-assembling peptide P11-4 is the first caries treatment approach aiming to regenerate decayed enamel. P11-4 initiates formation of de novo hydroxyapatite in the depth of early carious lesions, adding a new advanced therapy option for preventive dentistry.

[Tibiotalocalcaneal arthrodesis using a compressive retrograde locking nail with hindfoot valgus]. / Die tibiotalokalkaneare Arthrodese mit einem winkelstabilen Marknagel mit Rückfussvalgus und Kompressionsmöglichkeit.

AIM: The purpose of this study was to evaluate the first clinical experiences with the newest generation retrograde arthrodesis nail. METHODS: 28 patients who had tibiotalocalcaneal arthrodesis between 2005 and 2007 using a retrograde compression nail fixation (T2 AAN, Stryker, Duisburg, Germany) were retrospectively reviewed. Complications, functional outcome scores, and patient satisfaction were determined and the radiographs were evaluated for bony healing. RESULTS: The mean time interval until follow-up was 16 months (range: 7-27). All but 1 ankle showed a radiographically healed arthrodesis. 25 patients (89 %) were satisfied with the outcome. The average functional scores at follow-up were 64 (38-86 points) points for the American Orthopedics Foot and Ankle Score (AOFAS) and 65 points for the Mazur Ankle Scoring System (30-83 points). We recorded complications in 7 patients (25 %) including 1 deep infection with breakage of the calcaneus screw, 3 reinfections, 1 deep vein thrombosis, 1 intraoperative fracture of the tibia, 1 delayed union and 1 non-union. CONCLUSION: Tibiotalocalcaneal arthrodesis is a salvage procedure. Using a specifically designed retrograde intramedullary nail is a reliable method to achieve fusion. Patient satisfaction is high, but the procedure is demanding and complications are frequent. After infections the indication for nail arthrodesis should be evaluated carefully in each case.