Analysis of 8.5 mm Long Dental Implants Provided with Splinted or Solitary Implant Restorations: A 15-Year Prospective Study.

Background/Objectives: The long-term effects of implant properties, such as implant length, platform switch, and crown splinting, on peri-implant health require more investigation. Therefore, the aim was to assess the long-term peri-implant health and patient satisfaction in a patient cohort, obtained from two prospective randomized controlled trials, who received 8.5 mm long dental implants, with either splinted or solitary suprastructures and with or without a platform switch, over a period of 15 years. Methods: One hundred and twenty-two patients received either one or two 8.5 mm long dental implants (223 dental implants) with and without platform switch, restored with either a solitary (n = 89) or a splinted (n = 134) restoration in the posterior region. Clinical and radiographical parameters and patient satisfaction were prospectively recorded at 1 month, and 1, 5, and 15 years after the placement of the restoration. Patient satisfaction was recorded with a self-administered questionnaire using a 5-point scale and a visual analog scale (0-10). Results: Eighty-one patients with one hundred and fifty-four implants were assessed after a 15-year follow-up. The clinical parameters were low and comparable between the implant types (OsseoTite XP Certain, OsseoTite XP Certain Prevail, NanoTite XP Certain, NanoTite XP Certain Prevail, PalmBeach Gardens, FL, USA) over time. The implants that incorporated a platform switch showed significantly less bone loss than the implants without a platform switch (-0.37 mm, 95% CI -0.69 to -0.05 mm, p = 0.024 and ß = -0.47, 95% CI -0.80 to -0.14, p = 0.006). The implants with splinted restorations experienced more bone loss over time compared to the implants with solitary restorations (0.39 mm, 95% CI 0.15-0.63, p = 0.002). Patient satisfaction was high after 15 years. Conclusions: All the tested dental implants with 8.5 mm length provide satisfactory 15-year results with regard to the clinical and radiographical parameters as well as patient satisfaction. The platform-matched implants were associated with more bone loss compared to the platform-switched implants, and the implants with splinted crowns portrayed more bone loss than the solitary implant crowns.

Prognostic value of single photon emission computed tomography myocardial perfusion imaging for the prediction of MACE in pre- kidney transplant recipients: A systematic review and meta-analysis.

BACKGROUND: Kidney transplantation provides substantial benefits in extending survival and improving quality of life for patients with end-stage renal disease. The incidence of major adverse cardiac events (MACE) increases with a decline of kidney function in patients with chronic kidney disease. After kidney transplantation, the incidence of MACE remains high. The objective of this study was to assess the prognostic significance of pre-transplant single-photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI) in kidney transplant recipients. METHODS: A systematic literature search was performed between January 1st 2015 and March 26th 2024 in PubMed, EMBASE, Web of Science and The Cochrane Library to identify the prognostic value of SPECT MPI for developing MACE (primary outcome) and mortality (secondary outcome) in kidney transplant recipients (PROSPERO CRD42020188610). Risk of bias was assessed. Meta-analyses and subgroup analyses were performed using random-effects models. RESULTS: Six studies comprising 2090 SPECT MPI scans were included. Abnormal SPECT MPI scans were associated with an increased risk of MACE post-transplantation (HR 1.62, 95% CI 1.27-2.06, p < 0.001). Subgroup analyses showed consistent findings across various patient populations and methodological differences. Sensitivity analyses supported the robustness of our findings. CONCLUSIONS: Current evidence showed that pre-transplant SPECT MPI has significant prognostic value in identifying kidney transplant candidates at risk for MACE post-transplantation. Integrating SPECT MPI into preoperative assessments might enhance risk stratification and guide clinical decision-making. Prospective studies are needed to refine risk prediction models.

Immediate single-tooth implant placement in bony defect sites: A 10-year randomized controlled trial.

BACKGROUND: It is unclear whether an intact buccal bony plate is a prerequisite for immediate implant placement in postextraction sockets. The aim of this 10-year randomized controlled trial was to compare peri-implant soft and hard tissue parameters, esthetic ratings of, and patient-reported satisfaction with immediate implant placement in postextraction sockets with buccal bony defects ≥5 mm in the esthetic zone versus delayed implant placement after alveolar ridge preservation. METHODS: Patients presenting a failing tooth in the esthetic region and a buccal bony defect ≥5 mm after an extraction were randomly assigned to immediate (Immediate Group, n = 20) or delayed (Delayed Group, n = 20) implant placement. The second-stage surgery and provisional restoration placement occurred 3 months after implant placement in both groups, followed by definitive restorations 3 months thereafter. During a 10-year follow-up period, marginal bone levels (primary outcome), buccal bone thickness, soft tissue parameters, esthetics, and patient-reported satisfaction were recorded. RESULTS: The mean marginal bone level change was -0.71 ± 0.59 mm and -0.36 ± 0.39 mm in the Immediate Group and the Delayed Group after 10 years (p = 0.063), respectively. The secondary outcomes were not significantly different between both groups. CONCLUSIONS: Marginal bone level changes, buccal bone thickness, clinical outcomes, esthetics, and patients' satisfaction following immediate implant placement, in combination with bone augmentation in postextraction sockets with buccal bony defects ≥5 mm, were not statistically different to those following delayed implant placement after ridge preservation in the esthetic zone. PLAIN LANGUAGE SUMMARY: Immediate implant placement in case of a failing tooth is a favorable treatment option for patients because it considerably shortens treatment time and the number of surgical treatments. The question is if an intact buccal bone wall is necessary for immediate implant placement. A 10-year study was performed in which 20 patients with a failing tooth in the frontal region of the upper jaw were treated with immediate implant placement and were compared with 20 patients in whom a more conventional treatment strategy was followed in which the failing tooth was first removed and the bone gap restored and the implant placed in a second step. After a 10-year follow-up period, it appeared that the bone around the implant was very stable, gums were healthy, and patients were very satisfied with the result. There was no difference between the two treatment procedures. Such results mean that professionals can discuss the procedure with the patient and apply the individual's preference.

Single crown restorations supported by 6-mm implants in the resorbed posterior mandible: A 10-year prospective case series.

PURPOSE: To assess marginal bone level changes, implant and restoration survival, condition of the peri-implant mucosa, and the patient's satisfaction with the single restoration supported by a 6-mm long implant in the posterior mandible after 10 years in function. MATERIALS AND METHODS: Twenty-one consecutive patients missing premolars or molars in the posterior mandible, with a bone volume consisting of a width of at least 6 mm and an estimated height of 8 mm between the top of the ridge and alveolar nerve, were included. Each patient received one or more 6-mm implants. After 3 months, the implants were restored with custom-made titanium abutments and cemented zirconia-based porcelain crowns. The clinical examination and radiograph data were assessed at restoration placement and after 12, 60, and 120 months. The patients answered a questionnaire to score their satisfaction before treatment and after 12, 60, and 120 months with the restoration in function. RESULTS: A total of 31 implants were placed. Implant survival was 100%. The 10-year mean marginal bone loss was 0.18 mm (SE: 0.08). The plaque, calculus, gingiva, and bleeding indices scores were low as was the mean pocket probing depth. The patients' satisfaction was high. CONCLUSION: The 10-year follow-up data of this limited case series study reveal that 6-mm dental implants inserted in the resorbed posterior mandible provide a solid basis for single tooth restorations.

Similar long-term outcomes for venous, bovine pericardial, and polyester patches for primary carotid endarterectomy.

BACKGROUND: Currently, the type of patch used for carotid endarterectomy closure depends on the preference of the operating surgeon. Various materials are available, including autologous venous patches, bovine pericardial patches (BPP), and synthetic patches. The purpose of this study was to compare the long-term outcomes. METHODS: All patients who underwent primary carotid endarterectomy with patch angioplasty using a venous, bovine, or polyester patch between 2010 and 2020 at two high-volume medical centers were included in this retrospective analysis on largely prospectively collected data. Study endpoints included long-term ipsilateral transient ischemic attack or cerebrovascular accident, restenosis, reintervention, and all-cause mortality. Cox proportional hazard models were fitted to assess the effect of patch type to each outcome. RESULTS: In total, 1481 CEAs were performed with a follow-up of 32 (13-65) months. Venous patch was used in 309 patients (20.9%), BPP in 1000 patients (67.5%), and polyester patch in 172 patients (11.6%). A preoperative symptomatic carotid artery stenosis of >50% was observed in 91.9% (n = 284) of the patients who received a venous patch, 92.1% (n = 921) of the patients who received BPP, and 90.7% (n = 156) of the patients who received a polyester patch (p = 0.799). Only in selected patients with an asymptomatic stenosis of >70% surgery was considered. Multivariable analyses showed no significant differences between the three patch types regarding long-term outcomes after adjusting for confounders. CONCLUSIONS: In patients undergoing primary carotid endarterectomy, the use of venous, bovine pericardial, or polyester patches seems equally safe and durable in terms of comparability in long-term outcomes.

Single immediate implant placement in the maxillary aesthetic zone with and without connective tissue grafting: Results of a 5-year randomized controlled trial.

AIM: To assess the 5-year effects of grafting connective tissue while undertaking single immediate implant placement and provisionalization at the mid-buccal mucosa level (MBML). Secondary outcomes were buccal bone wall thickness (BBT), marginal bone level (MBL) and patient satisfaction. MATERIALS AND METHODS: Sixty patients with a single failing tooth in the maxillary anterior region were provided with an immediately placed and provisionalized implant. At implant placement, the patients randomly received either a connective tissue graft from the maxillary tuberosity (n = 30, test group) or no graft (n = 30, control group). The alveolar socket classification was mainly Type 2A. Data were collected before removing the failing tooth (T0 ), and at 1 (T1 ), 12 (T12 ) and 60 (T60 ) months after final crown placement. The primary outcome was the change in MBML compared with the pre-operative situation. Additionally, the change in BBT, MBL, aesthetics (using the Pink Aesthetic Score-White Aesthetic Score), soft-tissue peri-implant parameters and patient satisfaction were assessed. RESULTS: At the 5-year follow-up, 27 patients could be analysed from each group. In each group, one implant was lost during the osseointegration period, within 3 months of placement, resulting in an implant survival rate of 96.7% in both groups. MBML change at T60 was -0.6 (-1.1 to -0.1) mm in the control group and 0.1 (-0.4 to 0.5) mm in the test group (p = .008). BBT and MBL, aesthetics, soft-tissue peri-implant parameters and patient satisfaction showed stable results and satisfied patients, without clinically relevant differences between the groups. CONCLUSIONS: This 5-year follow-up study shows that grafting connective tissue when replacing a single failing tooth with immediately placed and provisionalized implant results in favourable peri-implant tissues and fewer MBML changes.

Single crowns in the posterior maxilla supported by either 11-mm long implants with sinus floor augmentation or by 6-mm long implants: A 10-year randomized controlled trial.

OBJECTIVES: To compare the clinical performance of single crowns in the posterior maxilla supported by either 11-mm long implants combined with maxillary sinus floor augmentation (MSFA) surgery or by 6-mm long implants during a 10-year follow-up period. MATERIALS AND METHODS: Subjects were randomly allocated to receive one 11-mm long implant in combination MFSA or to receive one 6-mm long implant without any grafting. Twenty-one implants in 20 patients were placed in the 6-mm group and 20 implants in 18 patients were placed in the 11-mm group. Both groups were followed by clinical and radiographic examinations up to 10 years. Patients' satisfaction was also scored before treatment. RESULTS: Two patients died and eight patients moved during the follow-up. Two patients lost an implant in the 6-mm group and one implant was lost in the 11-mm group (implant survival 89.5% and 90.9%, respectively). From loading to 10 years' follow-up, mean ± SE marginal bone loss in the 6-mm group and 11-mm group was 0.18 ± 0.10 mm and 0.26 ± 0.12 mm, respectively, without a significant difference between the groups at 10 years (p = .650). In both groups, indices scores for plaque, calculus, gingiva and bleeding were low as well as mean pocket probing depth. Patients' satisfaction at 10 years was high in both groups; mean overall satisfaction in the 6-mm group and 11-mm group was 9.6 ± 0.6 and 9.2 ± 0.8, respectively (p = .168). CONCLUSIONS: Placement of 6-mm implants or 11-mm implants combined MFSA are equally successful during a 10-year follow-up period when applied for supporting a single restoration.

Dental implant treatment for two adjacent missing teeth in the esthetic region: A systematic review and 10-year results of a prospective comparative pilot study.

OBJECTIVES: The aim of the systematic review was to compare studies on implant-supported two-unit cantilever crowns with two adjacent implant-supported crowns in the anterior region. The second aim was to assess in a 10-year prospective comparative pilot study, hard and soft peri-implant tissue changes in patients with a missing central and adjacent lateral upper incisor, treated with either an implant-supported two-unit cantilever crown or two single implant-supported crowns. MATERIALS AND METHODS: Medline, Embase, and the Cochrane Central Register of Controlled Trials were searched (last search March 1, 2023). Inclusion criteria were studies reporting outcomes of two missing adjacent teeth in the esthetic region and treated with a single implant-supported two-unit cantilever fixed dental prosthesis, or with two solitary implant-supported crowns. Outcome measures assessed included implant survival (primary), changes in marginal bone and gingiva level, restoration survival, subjective and objective esthetic scores, papilla volume, mid-facial marginal mucosa level, probing depth, bleeding on probing, and biological and technical complications with ≥1-year follow-up. In addition, in a 10-year pilot study, the same outcome measures were assessed of five patients with a single implant-supported two-unit cantilever crown and compared with five patients with two adjacent single implant-supported crowns in the esthetic zone. RESULTS: Nine articles with 11 study groups were found eligible for data extraction. Meta-analyses of implant survival rates were 96.9% (mean follow-up 3.4 ± 1.4 years) for the implant-cantilever treatment and 97.6% (mean follow-up 3.0 ± 1.8 years) for the adjacent implants treatment (p = .79). In the 10-year comparative pilot study, no clinically relevant changes in hard and soft peri-implant tissue levels occurred in both groups. Patient satisfaction was also high in both groups. CONCLUSION: Single implant-supported two-unit crowns can be a viable alternative to the placement of two adjacent single implant crowns in the esthetic zone.

Long-term treatment outcomes with zygomatic implants: a systematic review and meta-analysis.

PURPOSE: The purpose of this study was to perform a systematic review with meta-analysis on the long-term survival rates of zygomatic implants (ZI). ZI success, prostheses survival and success, sinus pathology and patient reported outcomes were also investigated. METHODS: Preferred Reporting Items for Systematic Review and Meta-Analyses (PRISMA) guidelines were followed. Embase and OvidMedline databases were searched alongside the grey literature. The systematic review was recorded in PROSPERO (CRD42022358024). Studies reporting titanium/titanium alloy ZI survival data, ZI-supported prosthesis data, ZIs directly compared to any other implant therapy including grafted sites, a minimum follow-up time of 3 years and a minimum number of 10 patients were included. All study designs were considered if they met the inclusion criteria. Studies not involving ZIs, ZIs not made from titanium/titanium alloy, a follow-up time of < 3 years or < 10 patients, animal studies and in vitro studies were excluded. Long-term follow-up has not been defined in the literature. A minimum of 3 years follow-up was considered acceptable to capture survival after initial healing, alongside in-function prosthesis data via delayed or immediate load protocols. ZI success, was predominantly defined as ZI survival without biological or neurological complications. Meta-analyses were performed for ZI survival, ZI failure incidence, ZI success, loading protocol, prosthesis survival, and prevalence of sinusitis using random effects models. Descriptive analysis was used for ZI success, prosthesis success and patient reported outcome measures. RESULTS: Five hundred and seventy-four titles were identified, of which 18 met the inclusion criteria. Eligible studies included 1349 ZIs in 623 patients. Mean follow-up period was 75.4 months (range 36-141.6). The mean survival of ZIs was 96.2% [95% CI: 93.8; 97.7] at 6 years. Mean survival for delayed loading was 95% [95% CI: 91.7; 97.1] and 98.1% [95% CI: 96.2; 99.0] for immediate loading (p = 0.03). Annual incidence rate of ZI failure was 0.7% [95% CI 0.4; 1.0]. Mean ZI success was 95.7% [95% CI 87.8; 98.6]. Mean prosthesis survival was 94% [95% CI 88.6; 96.9]. Sinusitis prevalence was 14.2% [95% CI 8.8; 22.0] at 5 years. Patients' reported increased satisfaction with ZIs. CONCLUSIONS: ZIs have long-term survival comparable to conventional implants. Immediate loading showed a statistically significant increase in survival over delayed loading. Prosthesis survival was similar to that of prostheses supported by conventional implants, with similar complications. Sinusitis was the most frequently encountered biological complication. Patients reported improved outcome measures with ZI use.

Long-term outcome of patients with transposition of the great arteries and a systemic right ventricle: A systematic review and meta-analysis.

BACKGROUND: Patients with a transposition of the great arteries (TGA) and a systemic right ventricle are at risk of heart failure (HF) development, arrhythmia and early mortality. Prognostic evaluations in clinical studies are hampered by small sample sizes and single-centred approaches. We aimed to investigate yearly rate of outcome and factors affecting it. METHODS: A systematic literature search of four electronic databases (PubMed, EMBASE, Web of Science and Scopus) was conducted from inception to June 2022. Studies reporting the association of a systemic right ventricle with mortality with a minimal follow-up of 2 years during adulthood were selected. Incidence of HF hospitalization and/or arrhythmia were captured as additional endpoints. For each outcome, a summary effect estimate was calculated. RESULTS: From a total of 3891 identified records, 56 studies met the selection criteria. These studies described the follow-up (on average 7.27 years) of 5358 systemic right ventricle patients. The mortality incidence was 1.3 (1-1.7) per 100 patients/year. The incidence of HF hospitalization was 2.6 (1.9-3.7) per 100 patients/year. Predictors of poor outcome were a lower left ventricular (LV) and right ventricular ejection fraction (RVEF) (standardized mean differences (SMD) of -0.43 (-0.77 to -0.09) and - 0.85 (-1.35 to -0.35), respectively), higher plasma concentrations of NT-proBNP (SMD of 1.24 (0.49-1.99)), and NYHA class ≥2 (risk ratio of 2.17 (1.40-3.35)). CONCLUSIONS: TGA patients with a systemic right ventricle have increased incidence of mortality and HF hospitalization. A lower LVEF and RVEF, higher levels of NT-proBNP and NYHA class ≥2 are associated with poor outcome.

Outcomes of Omniflow® II prosthesis used for revascularization in the femoral tract both in infected and non-infected setting.

BACKGROUND: Evidence regarding the outcomes of Omniflow® II prosthesis in peripheral arterial revascularization at different anatomical sites and for different indications is scarce. Therefore, the aim of this study was to evaluate the outcomes of the Omniflow® II used at various positions within the femoral tract both in infected and non-infected setting. METHODS: Patients who underwent reconstructive lower leg vascular surgery with implantation of an Omniflow® II from 2014 until 2021 at five medical centers were retrospectively included (N.=142). Patients were subdivided into the following categories: femoro-femoral crossover (N.=19), femoral interposition (N.=18), femoro-popliteal (above-the-knee [N.=25; AK] or below-the-knee [N.=47; BK]), and femoro-crural bypass grafts (N.=33). Primary outcome was primary patency and secondary outcomes included primary assisted patency, secondary patency, major amputation, vascular graft infection, and mortality. Outcomes were compared according to different subgroups and the surgical setting (infected versus non-infected). RESULTS: The median follow-up was 35.0 (17.5-54.3) months. Three years primary patency of 58% was observed for femoro-femoral crossover bypass, 75% for femoral interposition graft, 44% for femoro-popliteal above-the-knee bypass, 42% for femoro-popliteal below-the-knee bypass, and 27% in the femoro-crural position (P=0.006). Freedom from major amputation at three years were 84% for femoro-femoral crossover bypass, 88% for femoral interposition bypass, 90% for femoro-popliteal AK bypass, 83% for femoro-popliteal BK bypass, and 50% for femoro-crural bypass (P<0.001). CONCLUSIONS: This study demonstrates the safety and feasibility of the use of Omniflow® II for femoro-femoral crossover-, femoral interposition-, and femoro-popliteal (AK and BK) bypass. Omniflow® II seems to be less suitable for femoro-crural bypass with a significantly lower patency compared to other positions.

Use of Omniflow® II Biosynthetic Graft for the Treatment of Vascular Graft and Endograft Infections.

BACKGROUND: Vascular graft/endograft infection is a rare but life-threatening complication of cardiovascular surgery and remains a surgical challenge. Several different graft materials are available for the treatment of vascular graft/endograft infection, each having its own advantages and disadvantages. Biosynthetic vascular grafts have shown low reinfection rates and could be a potential second best after autologous veins in the treatment of vascular graft/endograft infection. Therefore, the aim of our study was to evaluate the efficacy and morbidity of Omniflow® II for the treatment of vascular graft/endograft infection. METHODS: A multicenter retrospective cohort study was performed to evaluate the use of Omniflow® II in the abdominal and peripheral region to treat vascular graft/endograft infection between January 2014 and December 2021. Primary outcome was recurrent vascular graft infection. Secondary outcomes included primary patency, primary assisted patency, secondary patency, all-cause mortality, and major amputation. RESULTS: Fifty-two patients were included with a median follow-up duration of 26.5 (10.8-54.8) months. Nine (17%) grafts were implanted in intracavitary position and 43 (83%) in peripheral position. Most grafts were used as femoral interposition (n = 12, 23%), femoro-femoral crossover (n = 10, 19%), femoro-popliteal (n = 8, 15%), and aorto-bifemoral (n = 8, 15%) graft. Fifteen (29%) grafts were implanted extra-anatomically and 37 (71%) in situ. Eight patients (15%) presented with reinfection during follow-up, most of these patients received an aorto-bifemoral graft (n = 3, 38%). Intracavitary vascular grafting had a 33% (n = 3) reinfection rate and peripheral grafting 12% (n = 5; P = 0.025). The estimated primary patencies at 1, 2, and 3 years were 75%, 72%, and 72% for peripherally located grafts and 58% (at all timepoints) for intracavitary grafts (P = 0.815). Secondary patencies at 1, 2, and 3 years were 77% (at all timepoints) for peripherally located prostheses and 75% (at all timepoints) for intracavitary prostheses (P = 0.731). A significantly higher mortality during follow-up was observed in patients who received an intracavitary graft compared to patients with a peripheral graft (P = 0.003). CONCLUSIONS: This study highlights the efficacy and safety of the Omniflow® II biosynthetic prosthesis for the treatment of vascular graft/endograft infection, in absence of suitable venous material, with acceptable reinfection, patency, and freedom of amputation prevalences, especially in replacing peripheral vascular graft/endograft infection. However, a control group with either venous reconstruction or another alternative graft is needed to make firmer conclusions.

Patch angioplasty during carotid endarterectomy using different materials has similar clinical outcomes.

OBJECTIVE: Patch angioplasty during carotid endarterectomy (CEA) is commonly used to treat carotid artery stenosis. However, the choice of which patch to use remains a matter of debate. Autologous venous material has disadvantages such as wound-related problems at the harvest site and a prolonged intervention time. These limitations can be bypassed when synthetic or biological patches are used. Both materials have been associated with divergent advantages and disadvantages. Therefore, the aim of our study was to compare the long-term follow-up outcomes in patients who underwent CEA and closure with either a bovine pericardial patch (BPP) or polyester patch. METHODS: A retrospective cohort study was conducted including all patients who underwent primary CEA and closure with a BPP or a polyester patch between January 2010 and December 2020 at our tertiary referral center. In 2015, the BPP was introduced as an alternative for polyester. The primary outcome was the occurrence of transient ischemic attack (TIA) or cerebrovascular accident (CVA) during follow-up and secondary outcomes included restenosis, reintervention, all-cause mortality, and patch infection. Cox proportional hazard models were used and hazard ratios with 95% confidence intervals were used to predict these outcomes. RESULTS: We included 417 CEA patients; 254 patients (61%) received a BPP and 163 received (39%) a polyester patch. The mean age was 70.2 ± 8.7 years and 67% were male. The median follow-up time was 15 months (range, 12-27 months) for BPP and 42 months (range, 16-60 months) for polyester (P < .001). Postoperative hematoma (≤30 days) was significantly lower in the BPP cohort (2% BPP vs 6% polyester; P = .047). No other significant differences on short-term outcomes were found. Univariable Cox regression analyses showed no significant differences between the effect estimates of polyester and BPP on TIA or CVA (P = .106), restenosis (P = .211), reintervention (P = .549), or all-cause mortality (P = .158). No significant differences were found after adjusting for confounders in the multivariable analyses: TIA or CVA (P = .939), restenosis (P = .057), reintervention (P = .193) and all-cause mortality (P = .742). Three patients with a polyester patch had patch infection compared with none of the patients in the group who received a BPP. CONCLUSIONS: This large retrospective study showed comparable safety and durability of both BPP and polyester suggesting that both patch types can be safely applied for CEA with patch angioplasty. Patch infection was rare and was absent in the BPP group.

Reliability and accuracy of the torque applied to osteosynthesis screws by maxillofacial surgeons and residents.

Applying the right torque to osteosynthesis screws is important for undisturbed bone healing. This study aimed to compare test-retest and intra-individual reliabilities of the torque applied to 1.5 mm and 2.0 mm osteosynthesis screws by residents and oral and maxillofacial surgeons (OMF-surgeons), to define the reference torque intervals, and to compare reference torque interval compliances. Five experienced OMF-surgeons and 20 residents, 5 of each 4 residency years, were included. Each participant inserted six 1.5 × 4 mm and six 2.0 × 6 mm screws into a preclinical model at two test moments 2 weeks apart (T1 and T2). Participants were blinded for the applied torque. Descriptive statistics, reference intervals, and intra-class correlation coefficients (ICC) were calculated. The OMF-surgeons complied more to the reference intervals (1.5 mm screws: 95% and 2.0 mm screws: 100%) than the residents (82% and 90%, respectively; P = 0.009 and P = 0.007) with the ICCs ranging between 0.85-0.95 and 0.45-0.97, respectively. The residents' accuracy and reliability were inadequate regarding the 1.5 mm screws but both measures improved at T2 for both screw types compared to T1, indicating a learning effect. Training residents and/or verifying the applied torque by experienced OMF-surgeons remains necessary to achieve high accuracy and reliability, particularly for 1.5 mm screws.

Titanium or Biodegradable Osteosynthesis in Maxillofacial Surgery? In Vitro and In Vivo Performances.

Osteosynthesis systems are used to fixate bone segments in maxillofacial surgery. Titanium osteosynthesis systems are currently the gold standard. However, the disadvantages result in symptomatic removal in up to 40% of cases. Biodegradable osteosynthesis systems, composed of degradable polymers, could reduce the need for removal of osteosynthesis systems while avoiding the aforementioned disadvantages of titanium osteosyntheses. However, disadvantages of biodegradable systems include decreased mechanical properties and possible foreign body reactions. In this review, the literature that focused on the in vitro and in vivo performances of biodegradable and titanium osteosyntheses is discussed. The focus was on factors underlying the favorable clinical outcome of osteosyntheses, including the degradation characteristics of biodegradable osteosyntheses and the host response they elicit. Furthermore, recommendations for clinical usage and future research are given. Based on the available (clinical) evidence, biodegradable copolymeric osteosyntheses are a viable alternative to titanium osteosyntheses when applied to treat maxillofacial trauma, with similar efficacy and significantly lower symptomatic osteosynthesis removal. For orthognathic surgery, biodegradable copolymeric osteosyntheses are a valid alternative to titanium osteosyntheses, but a longer operation time is needed. An osteosynthesis system composed of an amorphous copolymer, preferably using ultrasound welding with well-contoured shapes and sufficient mechanical properties, has the greatest potential as a biocompatible biodegradable copolymeric osteosynthesis system. Future research should focus on surface modifications (e.g., nanogel coatings) and novel biodegradable materials (e.g., magnesium alloys and silk) to address the disadvantages of current osteosynthesis systems.

Biocompatibility and degradation comparisons of four biodegradable copolymeric osteosynthesis systems used in maxillofacial surgery: A goat model with four years follow-up.

Applying biodegradable osteosyntheses avoids the disadvantages of titanium osteosyntheses. However, foreign-body reactions remain a major concern and evidence of complete resorption is lacking. This study compared the physico-chemical properties, histological response and radiographs of four copolymeric biodegradable osteosynthesis systems in a goat model with 48-months follow-up. The systems were implanted subperiosteally in both tibia and radius of 12 Dutch White goats. The BioSorb FX [poly(70LLA-co-30DLLA)], Inion CPS [poly([70-78.5]LLA-co-[16-24]DLLA-co-4TMC)], SonicWeld Rx [poly(DLLA)], LactoSorb [poly(82LLA-co-18GA)] systems and a negative control were randomly implanted in each extremity. Samples were assessed at 6-, 12-, 18-, 24-, 36-, and 48-month follow-up. Surface topography was performed using scanning electron microscopy (SEM). Differential scanning calorimetry and gel permeation chromatography were performed on initial and explanted samples. Histological sections were systematically assessed by two blinded researchers using (polarized) light microscopy, SEM and energy-dispersive X-ray analysis. The SonicWeld Rx system was amorphous while the others were semi-crystalline. Foreign-body reactions were not observed during the complete follow-up. The SonicWeld Rx and LactoSorb systems reached bone percentages of negative controls after 18 months while the BioSorb Fx and Inion CPS systems reached these levels after 36 months. The SonicWeld Rx system showed the most predictable degradation profile. All the biodegradable systems were safe to use and well-tolerated (i.e., complete implant replacement by bone, no clinical or histological foreign body reactions, no [sterile] abscess formation, no re-interventions needed), but nanoscale residual polymeric fragments were observed at every system's assessment.

Linear and profilometric changes of the mucosa following soft tissue augmentation in the zone of aesthetic priority: A systematic review and meta-analysis.

OBJECTIVES: To assess the outcomes of soft tissue augmentation, in terms of change in level and thickness of mid-buccal mucosa, at implants sites in the zone of the aesthetic priority. MATERIAL AND METHODS: MEDLINE, EMBASE and Cochrane Central Register of Controlled Trials databases were searched (last search on 1 June 2020). Inclusion criteria were studies reporting outcomes of different materials and timing of grafting in patients undergoing soft tissue augmentation at implant sites in the aesthetic zone with a follow-up of ≥1 year after implant placement. Outcome measures assessed included changes in level and thickness of mid-buccal mucosa, implant survival, peri-implant health and patients' satisfaction. RESULTS: Eighteen out of 2,185 articles fulfilled the inclusion criteria. Meta-analysis revealed a significant difference in vertical mid-buccal soft tissue change (0.34 mm, 95% CI: 0.13-0.56, p = .002) and mid-buccal mucosa thickness (0.66 mm, 95% CI: 0.35-0.97, p < .001) following immediate implant placement in favour of the use of a graft versus no graft. Mean difference in mid-buccal mucosa level following delayed implant placement (0.17 mm, 95% CI: 0.01-0.34, p = .042) was also in favour of the use of a graft versus no graft. With regard to mucosa thickness, the use of a graft was not in favour compared with no graft following delayed implant placement (0.22 mm, 95% CI: -0.04-0.47, p = .095). Observed changes remained stable in the medium term. CONCLUSION: Soft tissue augmentation in the zone of the aesthetic priority results in less recession and a thicker mid-buccal mucosa following immediate implant placement and less recession in mid-buccal mucosa following delayed implant placement compared with no graft.

Efficacy and morbidity of biodegradable versus titanium osteosyntheses in orthognathic surgery: A systematic review with meta-analysis and trial sequential analysis.

Titanium osteosynthesis is currently the gold standard in orthognathic surgery. Use of biodegradable osteosyntheses avoids removal of plates/screws in a second operation. This systematic review aimed to assess the efficacy and morbidity of biodegradable vs. titanium osteosyntheses in orthognathic surgery (PROSPERO CRD42018086477). Patients with syndromic disorder(s) and/or cleft lip/palate were excluded. Randomised, prospective and retrospective controlled studies were searched for in nine databases (February 2021). The time periods perioperative, short-term, intermediate, long-term, and overall follow-up were studied. Meta-analyses were performed using random-effects models. A total of 9073 records was assessed, of which 33 were included, comprising 2551 patients. Seven RCTs had 'some concerns' while another seven RCTs had 'high' risk of bias (Cochrane-RoB2). No differences in malunion (qualitative analyses), mobility of bone segments [RR 1.37 (0.47; 3.99)], and malocclusion [RR 0.93 (0.39; 2.26)] were found. The operative time was longer in the biodegradable group [SMD 0.50 (0.09; 0.91)]. Symptomatic plate/screw removal was comparable among both groups [RR 1.29 (0.68; 2.44)]. Skeletal stability was similar in most types of surgery. Biodegradable osteosyntheses is a valid alternative to titanium osteosyntheses for orthognathic surgery, but with longer operation times. Since the quality of evidence varied from very low to moderate, high-quality research is necessary to elucidate the potential of biodegradable osteosyntheses.

A new tool to assess Clinical Diversity In Meta-analyses (CDIM) of interventions.

OBJECTIVE: To develop and validate Clinical Diversity In Meta-analyses (CDIM), a new tool for assessing clinical diversity between trials in meta-analyses of interventions. STUDY DESIGN AND SETTING: The development of CDIM was based on consensus work informed by empirical literature and expertise. We drafted the CDIM tool, refined it, and validated CDIM for interrater scale reliability and agreement in three groups. RESULTS: CDIM measures clinical diversity on a scale that includes four domains with 11 items overall: setting (time of conduct/country development status/units type); population (age, sex, patient inclusion criteria/baseline disease severity, comorbidities); interventions (intervention intensity/strength/duration of intervention, timing, control intervention, cointerventions); and outcome (definition of outcome, timing of outcome assessment). The CDIM is completed in two steps: first two authors independently assess clinical diversity in the four domains. Second, after agreeing upon scores of individual items a consensus score is achieved. Interrater scale reliability and agreement ranged from moderate to almost perfect depending on the type of raters. CONCLUSION: CDIM is the first tool developed for assessing clinical diversity in meta-analyses of interventions. We found CDIM to be a reliable tool for assessing clinical diversity among trials in meta-analysis.