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Clinical and patient-reported outcome of implant restorations with internal conical connection in daily dental practices: prospective observational multicenter trial with up to 7-year follow-up.

ABSTRACT: BACKGROUND:The interpretation of the results of randomized clinical trials is often questioned in relation with daily circumstances in practices. This prospective observational multicenter study was instigated to reflect the need for information in real-life situations with dental implants with internal conical implant-abutment connection (Conelog implant system). The implants were followed up at least 5-year post-loading; survival analysis (Kaplan-Meier), changes of soft tissue, and bone level over time, as well as patient satisfaction were evaluated. RESULTS:In total, 130 dental implants were placed in 94 patients (64 female, 30 male). Mean age of patients was 50.4 ± 13.7. At 5-year post-loading, 104 implants in 76 patients were available for evaluation. The cumulative implant survival rate was 96.6%. After an initial bone remodeling process post-surgery (bone loss of - 0.52 ± 0.55?mm), the bone level change remained clinically stable from loading to 5-year post-loading (- 0.09 ± 0.43?mm). Patient satisfaction surveyed by questionnaire (comfort, ability to chew and taste, esthetics, general satisfaction) steadily increased towards the end. At the last study follow-up, all the patients rated their general satisfaction as either very satisfied (87.5%) or satisfied (12.5%). CONCLUSION:The study implants have shown to be highly effective with reliable peri-implant tissue stability over the 5 to 7?years of observation for both single tooth restorations and fixed partial dentures while used in standard conditions in daily dental practice. The results obtained are comparable with those obtained in controlled clinical trials.

SUBMITTER: Ackermann KL

PROVIDER: S-EPMC7138872 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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Clinical and patient-reported outcome of implant restorations with internal conical connection in daily dental practices: prospective observational multicenter trial with up to 7-year follow-up.

Ackermann Karl-Ludwig KL Barth Thomas T Cacaci Claudio C Kistler Steffen S Schlee Markus M Stiller Michael M

International journal of implant dentistry 20200408 1

<h4>Background</h4>The interpretation of the results of randomized clinical trials is often questioned in relation with daily circumstances in practices. This prospective observational multicenter study was instigated to reflect the need for information in real-life situations with dental implants with internal conical implant-abutment connection (Conelog implant system). The implants were followed up at least 5-year post-loading; survival analysis (Kaplan-Meier), changes of soft tissue, and bon ...[more]

PMID: 32266497

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Project description:Resin-based dental materials may intraorally release their chemical components and bisphenol A. The New England Children's Amalgam Trial found that children randomized to amalgam had better psychosocial outcomes than those assigned to composites for posterior tooth restorations. The objective of this study was to examine whether greater exposure to dental composites is associated with psychosocial problems in children.Analysis of treatment-level data from the New England Children's Amalgam Trial, a 2-group randomized safety trial comparing amalgam with the treatment plan of bisphenol A-glycidyl methacrylate (bisGMA)-based composite and urethane dimethacrylate-based polyacid-modified composite (compomer), among 534 children aged 6 to 10 years at baseline. Psychosocial function at follow-up (n = 434) was measured by using the self-reported Behavior Assessment System for Children (BASC-SR) and parent-reported Child Behavior Checklist (CBCL).Children with higher cumulative exposure to bisGMA-based composite had poorer follow-up scores on 3 of 4 BASC-SR global scales: Emotional Symptoms (? = 0.8, SE = 0.3, P = .003), Clinical Maladjustment (? = 0.7, SE = 0.3, P = .02), and Personal Adjustment (? = -0.8, SE = 0.2, P = .002). Associations were stronger with posterior-occlusal (chewing) surfaces, where degradation of composite was more likely. For CBCL change, associations were not statistically significant. At-risk or clinically significant scores were more common among children with greater exposure for CBCL Total Problem Behaviors (16.3% vs 11.2%, P-trend = .01) and numerous BASC-SR syndromes (eg, ? 13 vs 0 surface-years, Interpersonal Relations 13.7% vs 4.8%, P-trend = .01). No associations were found with compomer, nor with amalgam exposure levels among children randomized to amalgam.Greater exposure to bisGMA-based dental composite restorations was associated with impaired psychosocial function in children, whereas no adverse psychosocial outcomes were observed with greater urethane dimethacrylate-based compomer or amalgam treatment levels.

Project description:BackgroundMore personalized implant designs for total knee arthroplasty might optimize the clinical outcome after surgery. One of these personalized implant designs is the Persona knee implant system (Zimmer Biomet, Warsaw, Indiana, USA). The primary objective of this study was to determine patient reported outcomes and implant survivorship of the Persona Knee system used in primary total knee arthroplasty, up to two years after surgery.MethodsFrom November 2013 to July 2016 consecutive patients undergoing primary total knee arthroplasty were enrolled in a prospective observational cohort study at three centers. Preoperatively, at 6 weeks, 6 months, 1 and 2 years after surgery, patients completed the Knee Injury and Osteoarthritis Outcome Score (KOOS), the Oxford Knee Score (OKS), the Knee Society Score (KSS, 2011, modified version) and the EQ-5D. Adverse Events were captured, assessed for relationship to device, and recorded in the study database. Furthermore, physical functioning was assessed by the orthopedic surgeon. Repeated measures analyses were performed on PROM scores. Kaplan Meier was used to calculate survivorship of the Persona Knee Implant System.ResultsA total of 146 total knee arthroplasties were performed. 61% (89/146) of the patients were female and mean age was 64.7 (± 6.9) years. Two years after surgery, one patient had a revision of the polyethylene insert because of a periprosthetic joint infection. Therefore, the Kaplan-Meier survival estimate at 2 years was 0.99 (0.95-1.00 95% CI). OKS increased from 22.1 (95% CI 20.9-23.3) to 41.8 (95% CI 40.6-43.1) two years after surgery. Furthermore, all other PROMs also increased from before surgery to 2 year postoperatively.ConclusionThe Persona Knee implant is safe and effective and the clinical results up to two years after surgery are promising. PROMs results are very good; pain, function and quality of life all improved greatly after TKA. Further studies are needed to determine the long term clinical performance of the Persona prosthesis.Trial registrationClinicaltrials.gov ( NCT02337244 ). Registered June 1st, 2015. Retrospectively registered.

Dataset Information

Clinical and patient-reported outcome of implant restorations with internal conical connection in daily dental practices: prospective observational multicenter trial with up to 7-year follow-up.

Publications

Clinical and patient-reported outcome of implant restorations with internal conical connection in daily dental practices: prospective observational multicenter trial with up to 7-year follow-up.

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