BACKGROUND: Recently, the use of skeletal anchors in conjunction with fixed functional appliances (FFAs) has been advocated to enhance skeletal changes and reduce proclination of the lower incisors.

OBJECTIVE: To compare the skeletal and dento-alveolar effects of the use of FFAs with and without skeletal anchorage (miniscrews or miniplates).

SEARCH METHODS: Unrestricted electronic search of six databases and additional manual searches were performed up to July 2015.

ELIGIBILITY CRITERIA: Randomized and prospective non-randomized controlled trials directly comparing the use of FFA with and without skeletal anchorage, and involving growing patients with Class II malocclusion.

DATA COLLECTION AND ANALYSIS: Skeletal and dento-alveolar outcomes data were extracted in pre-defined sheets to collect study characteristics by two authors independently. After evaluating risk of bias, the standardized mean differences (SMDs) and 95% confidence intervals (CIs) were calculated with random-effects models. Subgrouping was pre-planned on the basis of the skeletal anchorage type used. Additional subgroup analysis was performed on the basis of the type of FFA used and the study design.

RESULTS: Seven studies were evaluated, and only five of which were included in the meta-analysis. The analysis included data from 157 Class II subjects (77 treated with FFA and skeletal anchorage, and 80 with FFA alone). Random-effects meta-analysis demonstrated no significant differences in the mandibular length and SNB angle changes [SMD = 1.98 (95% CI -0.11 to 4.07) and 1.20 (95% CI -0.37 to 2.77) respectively]. Significant differences were found between the inclination changes of lower and upper incisors [SMD = -1.43 (95% CI -2.59 to -0.27) and SMD = -1.04 (95% CI -1.57 to -0.51) respectively]. Subgroup differences were highly significant in most of the outcomes.

CONCLUSIONS: The studies reviewed provide insufficient evidence to form a conclusion regarding the effects of the use of skeletal anchorage with FFA. The available weak evidence suggests that the use of skeletal anchorage with FFA has no superior skeletal effects but is able to reduce proclination of the lower incisors.

INTRODUCTION: The objective of this 2-arm parallel randomized controlled trial was to evaluate patient acceptance of the mini-implant anchored Forsus Fatigue Resistant Device (FFRD) (3M Unitek, Monrovia, Calif).

METHODS: The study included 32 skeletal Class II girls. The eligibility criteria included a deficient mandible, a horizontal or neutral growth pattern, an increased overjet, and a full set of erupted permanent teeth. After the leveling and alignment stage, FFRDs and mini-implants were inserted; they were removed after the teeth reached an edge-to-edge incisor relationship. The patients were afterward asked to fill out assessment questionnaires regarding their experience with the FFRD.

OUTCOMES: The primary outcome of this study was to assess patient acceptance of the appliance and satisfaction with the results. The secondary outcomes were interference with functional activities, noticeability by others, pain, swelling, gum problems caused by the appliance, and appliance breakage.

RANDOMIZATION: Computer random sequence generation was done using block sizes of 6 and 4. Allocation concealment was achieved with sequentially numbered opaque sealed envelopes.

BLINDING: Blinding of the clinicians and the patients to the intervention was impossible, but it was done for the outcome assessment and the statistician.

RESULTS: The 32 patients were randomly allocated in a 1:1 ratio into 2 groups: 16 patients (mean age, 13.25 ± 1.12 years) received the FFRD alone (FFRD group), and 16 patients (mean age, 13.07 ± 1.41 years) had mini-implants in conjunction with FFRDs (FMI group). No statistically significant differences were reported between the 2 groups regarding ease of appliance insertion, noticeability by others, pain, swelling, effects on eating and speech, and gum bleeding; 100% and 87.5% were satisfied with the results in the FFRD and FMI groups, respectively, with a ridit value of 0.57 (95% confidence interval, 0.43-0.71; P = 0.36). No serious harm was observed other than swelling of the cheeks, which occurred in 4 patients.

CONCLUSIONS: There were no significant differences between the patients' acceptance of the FFRD and the mini-implant anchored FFRD. They were highly satisfied with the results. Neither group reported significant functional limitations.

REGISTRATION: This trial was not registered.

PROTOCOL: The protocol was not published before trial commencement.

FUNDING: The study was self-funded by the authors.

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BACKGROUND: Gastroesophageal varices are present in approximately 50% of patients with liver cirrhosis. The aim of this study was to evaluate liver stiffness measurement (LSM), Fib-4, Forns Index and Lok Score as noninvasive predictors of esophageal varices (EV).

METHODS: This prospective study included 65 patients with HCV-related liver cirrhosis. All patients underwent routine laboratory tests, transient elastograhy (TE) and esophagogastroduodenoscopy. FIB-4, Forns Index and Lok Score were calculated. The diagnostic performances of these methods were assessed using sensitivity, specificity, positive predictive value, negative predictive value, accuracy and receiver operating characteristic curves.

RESULTS: All predictors (LSM, FIB-4, Forns Index and Lok Score) demonstrated statistically significant correlation with the presence and the grade of EV. TE could diagnose EV at a cutoff value of 18.2kPa. Fib-4, Forns Index, and Lok Score could diagnose EV at cutoff values of 2.8, 6.61 and 0.63, respectively. For prediction of large varices (grade 2, 3), LSM showed the highest accuracy (80%) with a cutoff of 22.4kPa and AUROC of 0.801. Its sensitivity was 84%, specificity 72%, PPV 84% and NPV 72%. The diagnostic accuracies of FIB-4, Forns Index and Lok Score were 70%, 70% and76%, respectively, at cutoffs of 3.3, 6.9 and 0.7, respectively. For diagnosis of large esophageal varices, adding TE to each of the other diagnostic indices (serum fibrosis scores) increased their sensitivities with little decrease in their specificities. Moreover, this combination decreased the LR- in all tests.

CONCLUSION: Noninvasive predictors can restrict endoscopic screening. This is very important as non invasiveness is now a major goal in hepatology.