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Periodontology 2000 Feb 2023Flapless and fully guided implant placement has the potential to maximize efficacy outcomes and at the same time to minimize surgical invasiveness. The aim of the... (Meta-Analysis)
Meta-Analysis Review
Flapless and fully guided implant placement has the potential to maximize efficacy outcomes and at the same time to minimize surgical invasiveness. The aim of the current systematic review was to answer the following PICO question: "In adult human subjects undergoing dental implant placement (P), is minimally invasive flapless computer-aided fully guided (either dynamic or static computer-aided implant placement (sCAIP)) (I) superior to flapped conventional (free-handed implant placement (FHIP) or cast-based/drill partially guided implant placement (dPGIP)) surgery (C), in terms of efficacy, patient morbidity, long-term prognosis, and costs (O)?" Randomized clinical trials (RCTs) fulfilling specific inclusion criteria established to answer the PICO question were included. Two review authors independently searched for eligible studies, screened the titles and abstracts, performed full-text analysis, extracted the data from the published reports, and performed the risk of bias assessment. In cases of disagreement, a third review author took the final decision during ad hoc consensus meetings. The study results were summarized using random effects meta-analyses, which were based (wherever possible) on individual patient data (IPD). A total of 10 manuscripts reporting on five RCTs, involving a total of 124 participants and 449 implants, and comparing flapless sCAIP with flapped FHIP/cast-based partially guided implant placement (cPGIP), were included. There was no RCT analyzing flapless dynamic computer-aided implant placement (dCAIP) or flapped dPGIP. Intergroup meta-analyses indicated less depth deviation (difference in means (MD) = -0.28 mm; 95% confidence interval (CI): -0.59 to 0.03; moderate certainty), angular deviation (MD = -3.88 degrees; 95% CI: -7.00 to -0.77; high certainty), coronal (MD = -0.6 mm; 95% CI: -1.21 to 0.01; low certainty) and apical (MD = -0.75 mm; 95% CI: -1.43 to -0.07; moderate certainty) three-dimensional bodily deviations, postoperative pain (MD = -17.09 mm on the visual analogue scale (VAS); 95% CI: -33.38 to -0.80; low certainty), postoperative swelling (MD = -6.59 mm on the VAS; 95% CI: -19.03 to 5.85; very low certainty), intraoperative discomfort (MD = -9.36 mm on the VAS; 95% CI: -17.10 to -1.61) and surgery duration (MD = -24.28 minutes; 95% CI: -28.62 to -19.95) in flapless sCAIP than in flapped FHIP/cPGIP. Despite being more accurate than flapped FHIP/cPGIP, flapless sCAIP still resulted in deviations with respect to the planned position (intragroup meta-analytic means: 0.76 mm in depth, 2.57 degrees in angular, 1.43 mm in coronal, and 1.68 in apical three-dimensional bodily position). Moreover, flapless sCAIP presented a 12% group-specific intraoperative complication rate, resulting in an inability to place the implant with this protocol in 7% of cases. Evidence regarding more clinically relevant outcomes of efficacy (implant survival and success, prosthetically and biologically correct positioning), long-term prognosis, and costs, is currently scarce. When the objective is to guarantee minimal invasiveness at implant placement, clinicians could consider the use of flapless sCAIP. A proper case selection and consideration of a safety margin are, however, suggested.
Topics: Adult; Humans; Dental Implants; Dental Implantation, Endosseous; Surgery, Computer-Assisted; Surgical Flaps
PubMed: 35906928
DOI: 10.1111/prd.12440 -
Cells May 2020The pleiotropic behavior of mesenchymal stem cells (MSCs) has gained global attention due to their immense potential for immunosuppression and their therapeutic role in... (Review)
Review
The pleiotropic behavior of mesenchymal stem cells (MSCs) has gained global attention due to their immense potential for immunosuppression and their therapeutic role in immune disorders. MSCs migrate towards inflamed microenvironments, produce anti-inflammatory cytokines and conceal themselves from the innate immune system. These signatures are the reason for the uprising in the sciences of cellular therapy in the last decades. Irrespective of their therapeutic role in immune disorders, some factors limit beneficial effects such as inconsistency of cell characteristics, erratic protocols, deviating dosages, and diverse transfusion patterns. Conclusive protocols for cell culture, differentiation, expansion, and cryopreservation of MSCs are of the utmost importance for a better understanding of MSCs in therapeutic applications. In this review, we address the immunomodulatory properties and immunosuppressive actions of MSCs. Also, we sum up the results of the enhancement, utilization, and therapeutic responses of MSCs in treating inflammatory diseases, metabolic disorders and diabetes.
Topics: Adipocytes; Clinical Trials as Topic; Diabetes Mellitus; Humans; Immune Evasion; Mesenchymal Stem Cell Transplantation; Mesenchymal Stem Cells
PubMed: 32384763
DOI: 10.3390/cells9051145 -
Journal of the American College of... May 2022Pivotal trials of percutaneous left atrial appendage occlusion (LAAO) used specific postprocedure treatment protocols.
BACKGROUND
Pivotal trials of percutaneous left atrial appendage occlusion (LAAO) used specific postprocedure treatment protocols.
OBJECTIVES
This study sought to evaluate patterns of postprocedure care after LAAO with the Watchman device in clinical practice and compare the risk of adverse events for different discharge antithrombotic strategies.
METHODS
We evaluated patients in the LAAO Registry of the National Cardiovascular Data Registry who underwent LAAO with the Watchman device between 2016 and 2018. We assessed adherence to the full postprocedure trial protocol including standardized follow-up, imaging, and antithrombotic agents and then evaluated the most commonly used antithrombotic strategies and compared the rates and risk of adverse events at 45 days and 6 months by means of multivariable COX frailty regression.
RESULTS
Among 31,994 patients undergoing successful LAAO, only 12.2% received the full postprocedure treatment protocol studied in pivotal trials; the most common protocol deviations were with discharge antithrombotic medications. The most common discharge medication strategies were warfarin and aspirin (36.9%), direct oral anticoagulant (DOAC) and aspirin (20.8%), warfarin only (13.5%), DOAC only (12.3%), and dual antiplatelet therapy (5.0%). In multivariable Cox frailty regression, the adjusted risk of any adverse event through the 45-day follow-up visit were significantly lower for discharge on warfarin alone (HR: 0.692; 95% CI: 0.569-0.841) and DOAC alone (HR: 0.731; 95% CI: 0.574-0.930) compared with warfarin and aspirin. Warfarin alone retained lower risk at the 6-month follow-up.
CONCLUSIONS
In contemporary U.S. practice, practitioners rarely used the full U.S. Food and Drug Administration-approved postprocedure treatment protocols studied in pivotal trials of the Watchman device. Discharge after implantation on warfarin or DOAC without concomitant aspirin was associated with lower risk of adverse outcomes.
Topics: Anticoagulants; Aspirin; Atrial Appendage; Atrial Fibrillation; Fibrinolytic Agents; Frailty; Humans; Stroke; Treatment Outcome; Warfarin
PubMed: 35512858
DOI: 10.1016/j.jacc.2022.02.047 -
International Journal of Molecular... Jun 2020Tooth enamel is the outer covering of tooth crowns, the hardest material in the mammalian body, yet fracture resistant. The extremely high content of 95 wt% calcium... (Review)
Review
Tooth enamel is the outer covering of tooth crowns, the hardest material in the mammalian body, yet fracture resistant. The extremely high content of 95 wt% calcium phosphate in healthy adult teeth is achieved through mineralization of a proteinaceous matrix that changes in abundance and composition. Enamel-specific proteins and proteases are known to be critical for proper enamel formation. Recent proteomics analyses revealed many other proteins with their roles in enamel formation yet to be unraveled. Although the exact protein composition of healthy tooth enamel is still unknown, it is apparent that compromised enamel deviates in amount and composition of its organic material. Why these differences affect both the mineralization process before tooth eruption and the properties of erupted teeth will become apparent as proteomics protocols are adjusted to the variability between species, tooth size, sample size and ephemeral organic content of forming teeth. This review summarizes the current knowledge and published proteomics data of healthy and diseased tooth enamel, including advancements in forensic applications and disease models in animals. A summary and discussion of the status quo highlights how recent proteomics findings advance our understating of the complexity and temporal changes of extracellular matrix composition during tooth enamel formation.
Topics: Animals; Dental Enamel; Dental Enamel Proteins; Extracellular Matrix; Humans; Proteome; Tooth
PubMed: 32585904
DOI: 10.3390/ijms21124458 -
Revista Do Colegio Brasileiro de... 2020compare an accelerated physiotherapeutic protocol to a conventional physiotherapeutic protocol in total hip arthroplasty patients. (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVES
compare an accelerated physiotherapeutic protocol to a conventional physiotherapeutic protocol in total hip arthroplasty patients.
METHODS
a randomized double blinded clinical trial performed from August 2013 to November 2014. Forty-eight patients diagnosed with hip osteoarthritis submitted to a total hip arthroplasty surgery. An accelerated rehabilitation physiotherapy applied three times a day and start gait training on the first day or standard physiotherapy applied once a day and start gait training on the second or third day of hospitalization. The Merle dAubigné and Postel score (mobility, pain and gait), muscle strength force, range of motion, in hospital stay and time to start of gait training, were the outcomes.
RESULTS
the mean age was 64.46 years (10.37 years standard deviation). No differences were observed in age in different genders, and the two randomization groups were homogeneous. In hospital stay was lower in the intervention group compared to the control group, 3 (3-4) days [median (interquartile range)] versus 4 (4-5) days. Time to the start of gait training was early in the intervention group compared to the control group, 1 (1-1) days versus 2 (2-2) days. Higher muscle strength values were observed in the postoperative results in the intervention group compared to the control group for internal rotation, external rotation and abduction.
CONCLUSIONS
an accelerated physiotherapeutic protocol should be encouraged, because it shows favourable results in gait, muscle strength and length of hospital stay, even upon hospital discharge.
Topics: Adult; Aged; Arthroplasty, Replacement, Hip; Double-Blind Method; Female; Gait; Humans; Male; Middle Aged; Muscle Strength; Osteoarthritis, Hip; Physical Therapy Modalities; Postoperative Care; Range of Motion, Articular; Recovery of Function; Treatment Outcome
PubMed: 32844909
DOI: 10.1590/0100-6991e-20202548 -
Journal of Prosthodontic Research Jan 2022To review the current clinical studies regarding the accuracy of implant computer-guided surgery in partially edentulous patients and investigate potential influencing... (Meta-Analysis)
Meta-Analysis
PURPOSE
To review the current clinical studies regarding the accuracy of implant computer-guided surgery in partially edentulous patients and investigate potential influencing factors.
STUDY SELECTION
Electronic searches on the PubMed and Cochrane Central Register of Controlled Trials databases, and subsequent manual searches were performed. Two reviewers selected the studies following our inclusion and exclusion criteria. Qualitative review and meta-analysis of the implant placement accuracy were performed to analyze potential influencing factors. Angular deviation, coronal deviation, apical deviation, and depth deviation were evaluated as the accuracy outcomes.
RESULTS
Eighteen studies were included in this systematic review, including six randomized controlled trials, nine prospective studies, and three retrospective clinical studies. A total of 1317 implants placed in 642 partially edentulous patients were reviewed. Eight studies were evaluated using meta-analysis. Fully guided surgery showed statistically higher accuracy in angular (P <0.001), coronal (P <0.001), and apical deviation (P <0.05) compared with pilot-drill guided surgery. A statistically significant difference (P <0.001) was also observed in coronal deviation between the bounded edentulous (BES) and distal extension spaces (DES). A significantly lower angular deviation (P <0.001) was found in implants placed using computer-aided design/computer-aided manufacturing (CAD/CAM) compared to the conventional surgical guides.
CONCLUSION
The edentulous space type, surgical guide manufacturing procedure, and guided surgery protocol can influence the accuracy of computer-guided surgery in partially edentulous patients. Higher accuracy was found when the implants were placed in BES, with CAD/CAM manufactured surgical guides, using a fully guided surgery protocol.
Topics: Computer-Aided Design; Computers; Cone-Beam Computed Tomography; Dental Implantation, Endosseous; Dental Implants; Humans; Prospective Studies; Retrospective Studies; Surgery, Computer-Assisted
PubMed: 33504723
DOI: 10.2186/jpr.JPR_D_20_00184 -
BMC Musculoskeletal Disorders Jul 2021The purpose of this systematic review and meta-analysis is to compare the conservative and accelerated rehabilitation protocols in patients who underwent arthroscopic... (Meta-Analysis)
Meta-Analysis
BACKGROUND
The purpose of this systematic review and meta-analysis is to compare the conservative and accelerated rehabilitation protocols in patients who underwent arthroscopic rotator cuff repair in terms of clinical outcomes and range of motions at 3, 6, 12, and 24-month follow-up.
METHODS
According to PRISMA guidelines, a systematic review of the literature was performed. For each included article, the following data has been extracted: authors, year, study design, level of evidence, demographic characteristics, follow-up, clinical outcomes, range of motions, and retear events. A meta-analysis was performed to compare accelerated versus conservative rehabilitation protocols after arthroscopic rotator cuff repair. The retear rate, postoperative Constant-Murley score and range of motions at 3, 6, 12, and 24 months of follow-up were the outcomes measured.
RESULTS
The search strategy yielded 16 level I-II clinical studies. A total of 1424 patients, with 732 patients and 692 in the accelerated and conservative group, were included. The average age (mean ± standard deviation) was 56.1 ± 8.7 and 56.6 ± 9 in the accelerated and conservative group. The mean follow-up was 12.5 months, ranging from 2 to 24 months. The meta-analysis showed no statistically significant differences in terms of retear rate between the groups (P = 0.29). The superiority of the accelerated group was demonstrated in terms of external rotation (P < 0.05) at 3-month follow-up; in terms of forward elevation, external rotation, abduction (P < 0.05), but not in terms of Constant-Murley score at 6-month follow-up; in terms of forward elevation (P < 0.05) at 12-month follow-up. No significant differences between the two group were highlighted at 24-month follow-up.
CONCLUSIONS
No statistically significant differences in the retear rate among the accelerated and conservative group have been demonstrated. On the other hand, statistically and clinically significant differences were found in terms of external rotation at 3 and 6 months of follow-up in favour of the accelerated group. However, no differences between the two groups were detected at 24 months follow-up.
Topics: Arthroscopy; Humans; Range of Motion, Articular; Rotator Cuff; Rotator Cuff Injuries; Treatment Outcome
PubMed: 34303366
DOI: 10.1186/s12891-021-04397-0 -
Haematologica Sep 2020CD5-positive diffuse large B-cell lymphoma (CD5+ DLBCL) is characterized by poor prognosis and a high frequency of central nervous system relapse after standard...
DA-EPOCH-R combined with high-dose methotrexate in patients with newly diagnosed stage II-IV CD5-positive diffuse large B-cell lymphoma: a single-arm, open-label, phase II study.
CD5-positive diffuse large B-cell lymphoma (CD5+ DLBCL) is characterized by poor prognosis and a high frequency of central nervous system relapse after standard immunochemotherapy. We conducted a phase II study to investigate the efficacy and safety of dose-adjusted (DA)- EPOCH-R (etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab) combined with high-dose methotrexate (HD-MTX) in newly diagnosed patients with CD5+ DLBCL. Previously untreated patients with stage II to IV CD5+ DLBCL according to the 2008 World Health Organization classification were eligible. Four cycles of DA-EPOCH-R followed by two cycles of HD-MTX and four additional cycles of DAEPOCH- R (DA-EPOCH-R/HD-MTX) were planned as the protocol treatment. The primary end point was 2-year progression-free survival (PFS). Between September 25, 2012, and November 11, 2015, we enrolled 47 evaluable patients. Forty-five (96%) patients completed the protocol treatment. There were no deviations or violations in the DA-EPOCH-R dose levels. The complete response rate was 91%, and the overall response rate was 94%. At a median follow up of 3.1 years (range, 2.0-4.9 years), the 2- year PFS was 79% [95% confidence interval (CI): 64-88]. The 2-year overall survival was 89% (95%CI: 76-95). Toxicity included grade 4 neutropenia in 46 (98%) patients, grade 4 thrombocytopenia 12 (26%) patients, and febrile neutropenia in 31 (66%) patients. No treatment-related death was noted during the study. DA-EPOCH-R/HD-MTX might be a first-line therapy option for stage II-IV CD5+ DLBCL and warrants further investigation. (Trial registered at: UMIN-CTR: UMIN000008507.).
Topics: Antineoplastic Combined Chemotherapy Protocols; Cyclophosphamide; Doxorubicin; Etoposide; Humans; Lymphoma, Large B-Cell, Diffuse; Methotrexate; Neoplasm Recurrence, Local; Prednisone; Rituximab; Vincristine
PubMed: 33054055
DOI: 10.3324/haematol.2019.231076 -
Therapeutic Innovation & Regulatory... Jul 2022Little to no data exist quantifying and benchmarking the magnitude of protocol deviation experience.
BACKGROUND
Little to no data exist quantifying and benchmarking the magnitude of protocol deviation experience.
METHODS
Nearly two-dozen companies provided the Tufts Center for the Study of Drug Development (Tufts CSDD) with data on the design and the performance of 187 protocols.
RESULTS
The results of this working group study show that phase II and III protocols have a mean total of 75 and 119 protocol deviations, respectively, involving nearly one-third of all patients enrolled in each clinical trial. Oncology clinical trials have the highest relative mean number of protocol deviations affecting more than 40% of patients enrolled in each trial. The number of endpoints, the number of procedures per visit, and the number of countries were modestly positively associated with and predictive of, the incidence of deviations per protocol. A strong positive relationship was shown between the number of investigative sites and the number of protocol deviations.
CONCLUSION
The results of this initial study provide useful measures that sponsor companies can use to benchmark their own protocol deviation experience, identify factors most associated with protocol deviations, and determine whether remediation is warranted.
Topics: Benchmarking; Humans
PubMed: 35378712
DOI: 10.1007/s43441-022-00401-4 -
Acta Ophthalmologica Dec 2022To compare retinal function assessed by full-field electroretinography (ffERG) and multifocal electroretinography (mfERG) in diabetes without retinopathy, diabetes with...
OBJECTIVE
To compare retinal function assessed by full-field electroretinography (ffERG) and multifocal electroretinography (mfERG) in diabetes without retinopathy, diabetes with moderate non-proliferative diabetic retinopathy (NPDR) and in the absence of diabetes.
METHODS
Scotopic and photopic ffERG and mfERG was made in non-fasting volunteers, including 26 diabetic participants without retinopathy, 22 diabetic participants with moderate NPDR and 22 participants without diabetes using full International Society for Clinical Electrophysiology of Vision protocols.
RESULTS
Of the ffERG responses, significant deviation (p ≤ 0.05, corrected for multiple sampling and other relevant confounders) from the non-diabetic participants was seen in the diabetic participants only for the OP1-OP3 oscillatory amplitudes and the OP2 implicit time. This finding was independent of whether retinopathy was present or not. For the mfERG, minor amplitude or implicit time deviations were found for a small number of rings (R2, R4 and R5). Receiver of operating characteristic analysis showed that the single most prominent abnormality of the ffERG in diabetes, regardless of whether retinopathy was present or not, was the OP2 implicit time (area under the curve ≥ 0.80).
CONCLUSION
This bi-modal study of electroretinographic characteristics found that the most prominent anomaly associated with diabetes was a prolongation of the implicit time of the OP2 of the scotopic ffERG, while the most prominent added effect of non-proliferative diabetic retinopathy was a further prolongation of the OP2 implicit time. Although the variation in ERG characteristics is far too large for diagnostic purposes, the close association of the oscillatory potentials with the amacrine cells of the retina indicate that their function is particularly sensitive to diabetes.
Topics: Humans; Electroretinography; Diabetic Retinopathy; Diabetes Mellitus, Type 2; Retina
PubMed: 35661609
DOI: 10.1111/aos.15184