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.

Mechanical strength of stock and custom abutments as original and aftermarket components after thermomechanical aging.

OBJECTIVES: The study aimed to assess the impact on the mechanical strength and failure patterns of implant-abutment complexes of choosing different abutment types, designs and manufacturers, aiding in selecting the optimal restorative solution. Stock and custom abutments from original and aftermarket suppliers were subjected to thermomechanical aging. MATERIAL AND METHODS: Stock and custom abutments from the implant manufacturer (original) and a aftermarket supplier (nonoriginal) were connected to identical implants with internal connection. Custom abutments were designed in a typical molar and premolar design, manufactured using the workflow from the respective suppliers. A total of 90 implants (4 mm diameter, 3.4 mm platform, 13 mm length) equally divided across 6 groups (three designs, two manufacturers) underwent thermo-mechanical aging according to three different regimes, simulating five (n = 30) or 10 years (n = 30) of clinical function, or unaged control (n = 30). Subsequently, all samples were tested to failure. RESULTS: During aging, no failures occurred. The mean strength at failure was 1009N ± 171, showing significant differences between original and nonoriginal abutments overall (-230N ± 27.1, p < .001), and within each abutment type (p = .000), favoring original abutments. Aging did not significantly affect the failure load, while the type of abutment and manufacturer did, favoring original and custom-designed abutments. The most common failure was implant bending or deformation, significantly differing between original and nonoriginal abutments and screws. All failure tests resulted in clinically unsalvageable implants and abutments. CONCLUSIONS: Within the limitations of this study, original abutments exhibited a higher mechanical strength compared to the nonoriginal alternative, regardless of the amount of simulated clinical use. Similarly, custom abutments showed higher mechanical strength compared to stock abutments. However, mechanical strength in all abutments tested was higher than average chewing forces reported in literature, thus components tested in this study can be expected to perform equally well in clinical situations without excessive force.

Mechanical performance of patient-specific prefabricated temporary shell versus laboratory-fabricated CAD/CAM provisional implant-supported single-tooth restorations: A laboratory study.

OBJECTIVE: To evaluate the mechanical performance of patient-specific prefabricated temporary shell versus laboratory-fabricated CAD/CAM provisional restorations on titanium temporary abutments, with and without thermo-mechanical ageing. MATERIALS AND METHODS: Implants with a conical connection were divided into four groups (n = 24) and restored with temporary shell or laboratory-fabricated central or lateral incisor PMMA restorations that were relined or bonded on titanium temporary abutments. The diameter of the central and lateral incisor groups' implants was regular (ϕ 4.3 mm) or narrow (ϕ 3.5 mm), respectively. Half of each group's specimens were subjected to ageing, simultaneous thermocycling (5-55°C) and chewing simulation (120,000 cycles, 50 N, 1.7 Hz) resulting in eight groups in total (n = 12). The aged specimens were evaluated with optical microscopy, and survival and complication rates were determined according to modified USPHS criteria. The non-aged specimens and those that had survived ageing were loaded until failure, whereupon bending moments were calculated. RESULTS: Survival rates after ageing were 100% for all groups. Apart from wear facets (ϕ 2-3 mm) on the palatal restoration surface, no complications were observed. The mean fracture load and bending moments ranged between 597.6-847.1 N and 433.3-550.6 Ncm, respectively, with no significant differences between the eight groups (p = .25; p = .20). CONCLUSIONS: As patient-specific temporary shell central and lateral incisor provisional implant-supported restorations are mechanically stable enough to withstand clinical bite forces, even after thermo-mechanical ageing, they may serve as an alternative to laboratory-fabricated provisional restorations.

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.

Immediate implant placement with immediate or delayed provisionalization in the maxillary aesthetic zone: A 10-year randomized trial.

AIM: To compare the marginal bone level of immediately placed implants, with either immediate or delayed provisionalization (IP or DP), in the maxillary aesthetic zone after 10 years of function. MATERIALS AND METHODS: Participants with a failing tooth in the maxillary aesthetic zone were randomly assigned to immediate implant placement with either IP (n = 20) or DP (n = 20) after primary wound closure with a free gingival graft. The final restoration was placed 3 months after provisionalization. The primary outcome was change in marginal bone level. In addition, implant survival, restoration survival and success, peri-implant tissue health, mucosa levels, aesthetic indices, buccal bone thickness and patient satisfaction were evaluated. RESULTS: After 10 years, the mean mesial and distal changes in marginal bone level were -0.47 ± 0.45 mm and -0.49 ± 0.52 mm in the IP group and -0.58 ± 0.76 mm and -0.41 ± 0.72 mm in the DP group (p = .61; p = .71). The survival rate was 100% for the implants; for the restorations, it was 88.9% in the IP group and 87.5% in the DP group. Restoration success, according to modified USPHS criteria, was 77.8% in the IP group and 75.0% in the DP group. The prevalence of peri-implant mucositis was 38.9% and 35.7% and of peri-implantitis 0.0% and 6.3%, respectively, in the IP group and DP group (p = 1.0; p = .40). The Pink Esthetic Score and White Esthetic Score was 15.28 ± 2.32 in the IP group and 14.64 ± 2.74 in the DP group, both clinically acceptable (p = .48). The buccal bone thickness was lower in the DP group. Patient satisfaction was similar in both groups (p = .75). CONCLUSIONS: The mean marginal bone level changes after immediate implant placement with IP were similar to those after immediate placement with DP. CLINICAL TRIAL REGISTRATION: Registered in the National Trial Register (NL9340).

Digital versus conventional surgical guide fabrication: A randomized crossover study on operator preference, difficulty, effectiveness, and operating time.

AIM: If surgical guide fabrication is introduced in a dental education program, a digital and conventional workflow can be used. This study evaluated operator preference, perceived difficulty and effectiveness and operating time of both fabrication methods. MATERIALS AND METHODS: Forty participants in a university setting (students, n = 20; dentists, n = 20) with varying levels of dental experience, but no experience in surgical guide fabrication, were randomly assigned to consecutively fabricate surgical guides on a standardized training model, with either the digital or conventional workflow first. The operating time was measured, and operator preference and the perception of difficulty and effectiveness were assessed with a questionnaire. T tests were used for statistical analysis (α = .05). RESULT: Of the students, 95% preferred the digital workflow and of the dentists 70%. The perceived difficulty of the digital workflow was significantly lower than the conventional workflow in the student group. Both groups perceived the digital workflow to be more effective. The mean operating time (mm:ss) amounted 12:34 ± 2:24 (students) and 18:07 ± 6:03 (dentists) for the digital, and 22:20 ± 3:59 (students) and 20:16 ± 4:03 (dentists) for the conventional workflow. CONCLUSION: Both students and dentists prefer the digital workflow for surgical guide fabrication. Students perceive the digital workflow as less difficult and more effective than the conventional workflow. The operating time for surgical guide fabrication is shorter with a digital workflow. This study indicates that digital fabrication techniques for surgical guides are preferred to be incorporated into the dental curriculum to teach students about treatment planning in implant dentistry.

The Peri-Implant Microbiome-A Possible Factor Determining the Success of Surgical Peri-Implantitis Treatment?

The objective was to assess the effect of peri-implantitis surgery on the peri-implant microbiome with a follow-up of one year. A total of 25 peri-implantitis patients in whom non-surgical treatment has failed to solve peri-implantitis underwent resective surgical treatment. Their peri-implant pockets were sampled prior to surgical treatment (T0) and one year post treatment (T12). The natural dentition was sampled to analyse similarities and differences with the peri-implantitis samples. Treatment success was recorded. The change in microbial relative abundance levels was evaluated. The microbiota was analysed by sequencing the amplified V3-V4 region of the 16S rRNA genes. Sequence data were binned to amplicon sequence variants that were assigned to bacterial genera. Group differences were analysed using principal coordinate analysis, Wilcoxon signed rank tests, and t-tests. Beta diversity analyses reported a significant separation between peri-implantitis and natural dentition samples on T0 and T12, along with significant separations between successfully and non-successfully treated patients. Eubacterium was significantly lower on T12 compared to T0 for the peri-implantitis samples. Treponema and Eubacterium abundance levels were significantly lower in patients with treatment success on T0 and T12 versus no treatment success. Therefore, lower baseline levels of Treponema and Eubacterium seem to be associated with treatment success of peri-implantitis surgery. This study might aid clinicians in determining which peri-implantitis cases might be suitable for treatment and give a prognosis with regard to treatment success.

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.

Two adjacent implant-supported restorations in the aesthetic region: A 10-year prospective case series.

INTRODUCTION: The treatment outcome of two adjacent implant-supported restorations in the maxillary aesthetic region was assessed regarding peri-implant soft and hard tissues, and satisfaction during a 10-year follow-up period. METHODS: Twenty patients missing two adjacent teeth in the maxillary aesthetic region and treated with two implant-supported restorations were followed prospectively. The patients' clinical and radiographic parameters, as well as their satisfaction, were scored for a 10-year follow-up period. RESULTS: Seventeen patients' data were available for the 10-year follow-up. The survival rate of the implants and restorations was 100%. The 10-year mean peri-implant bone change at the side facing the adjacent tooth was +0.11 ± 0.57 mm and at the side facing the adjacent implant was -0.08 ± 0.50 mm. The peri-implant soft tissues were healthy and the patients' satisfaction was high, but the papilla-index showed compromised inter-implant papillae and low Pink Esthetic Scores. These figures were of the same magnitude at all time points. CONCLUSION: While it is difficult to obtain sufficient inter-implant papillae and satisfactory Pink Esthetic Scores, the initial treatment results remained stable and the patients were satisfied with the final result throughout the 10-year follow-up period.

Two or four implants for maxillary overdentures in edentulous patients: 1-year results of a randomized controlled trial.

INTRODUCTION: Maxillary implant overdenture therapy is a good treatment option for treating patients experiencing problems with their conventional maxillary denture. Retaining the overdenture with four implants and a bar attachment system serves as the current gold standard. However, there is a demand for less costly and less invasive treatment options. The aim of this randomized controlled trial was to compare marginal bone level change (MBLC), implant and overdenture survival, clinical, masticatory, and patient-related outcomes (PROMs) of maxillary implant overdentures with either two or four implants and a bar attachment system. MATERIALS AND METHODS: Forty edentulous participants were randomly allocated to two groups (n = 20), to receive either two or four implants in the maxilla. After healing, all the participants received an implant overdenture retained by a bar attachment system. All the participants were evaluated 1 and 12 months after overdenture placement. The primary outcome was MBLC. Secondary outcomes were implant and overdenture survival, clinical, masticatory, and PROMs. The outcomes were analyzed using parametric and non-parametric tests. RESULTS: MBLC was -0.03 mm in the 2-implant group and -0.16 mm in the 4-implant group (p = 0.21). Implant survival was 83.3% in the 2-implant group and 94.4% in the 4-implant group (p = 0.03). The median pocket depth change and clinical outcomes were low, and masticatory performance along with PROMs improved in both groups and did not differ significantly between them. CONCLUSION: Maxillary 4-implant overdentures perform better than maxillary 2-implant overdentures with a bar attachment system in terms of implant and overdenture survival and therefore remains the gold standard. However, both overdentures perform similarly in terms of MBLC, clinical, masticatory, and PROMs.

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.

Magnetically actuated glaucoma drainage device for regulating intraocular pressure after implantation.

The key risk factor for glaucoma is increased intraocular pressure (IOP). Glaucoma drainage devices implanted in the eye can reduce IOP and thus stop disease progression. However, most devices currently used in clinical practice are passive and do not allow for postsurgical IOP control, which may result in serious complications such as hypotony (i.e., excessively low IOP). To enable noninvasive IOP control, we demonstrate a novel, miniature glaucoma implant that will enable the repeated adjustment of the hydrodynamic resistance after implantation. This is achieved by integrating a magnetic microvalve containing a micropencil-shaped plug that is moved using an external magnet, thereby opening or closing fluidic channels. The microplug is made from biocompatible poly(styrene-block-isobutylene-block-styrene) (SIBS) containing iron microparticles. The complete implant consists of an SIBS drainage tube and a housing element containing the microvalve and fabricated with hot embossing using femtosecond laser-machined glass molds. Using in vitro and ex vivo microfluidic experiments, we demonstrate that when the microvalve is closed, it can provide sufficient hydrodynamic resistance to overcome hypotony. Valve function is repeatable and stable over time. Due to its small size, our implant is a promising, safe, easy-to-implant, minimally invasive glaucoma surgery device.

Role of Fe/Co Ratio in Dual Phase Ce0.8Gd0.2O2-δ-Fe3-xCoxO4 Composites for Oxygen Separation.

Dual-phase membranes are increasingly attracting attention as a solution for developing stable oxygen permeation membranes. Ce0.8Gd0.2O2-δ-Fe3-xCoxO4 (CGO-F(3-x)CxO) composites are one group of promising candidates. This study aims to understand the effect of the Fe/Co-ratio, i.e., x = 0, 1, 2, and 3 in Fe3-xCoxO4, on microstructure evolution and performance of the composite. The samples were prepared using the solid-state reactive sintering method (SSRS) to induce phase interactions, which determines the final composite microstructure. The Fe/Co ratio in the spinel structure was found to be a crucial factor in determining phase evolution, microstructure, and permeation of the material. Microstructure analysis showed that all iron-free composites had a dual-phase structure after sintering. In contrast, iron-containing composites formed additional phases with a spinel or garnet structure which likely contributed to electronic conductivity. The presence of both cations resulted in better performance than that of pure iron or cobalt oxides. This demonstrated that both types of cations were necessary to form a composite structure, which then allowed sufficient percolation of robust electronic and ionic conducting pathways. The maximum oxygen flux is jO2 = 0.16 and 0.11 mL/cm2·s at 1000 °C and 850 °C, respectively, of the 85CGO-FC2O composite, which is comparable oxygen permeation flux reported previously.

A Degradable Sustained-Release Drug Delivery System for Bleb-Forming Glaucoma Surgery.

Fibrosis of the filtering bleb is one of the main causes of failure after bleb-forming glaucoma surgery. Intraoperative application of mitomycin C (MMC) is the current gold standard to reduce the fibrotic response. However, MMC is cytotoxic and one-time application is often insufficient. A sustained-release drug delivery system (DDS), loaded with MMC, may be less cytotoxic and equally or more effective. Two degradable (polycaprolactone (PCL) and polylactic-co-glycolic acid (PLGA)) MMC-loaded DDSs are developed. Release kinetics are first assessed in vitro followed by rabbit implants in conjunction with the PRESERFLO MicroShunt. As a control, the MicroShunt is implanted with adjunctive use of a MMC solution. Rabbits are euthanized at postoperative day (POD) 28 and 90. The PLGA and PCL DDSs release (on average) 99% and 75% of MMC, respectively. All groups show functioning blebs until POD 90. Rabbits implanted with a DDS show more inflammation with avascular thin-walled blebs when compared to the control. However, collagen is more loosely arranged. The PLGA DDS shows less inflammation, less foreign body response (FBR), and more complete degradation at POD 90 when compared to the PCL DDS. Further optimization with regard to dosage is required to reduce side effects to the conjunctiva.

The Influence of Design Modifications and Microstructured Surface Topographies on Bleb Survival after Glaucoma Tube Shunt Implantation.

Lowering intraocular pressure (IOP) by placement of a glaucoma shunt is an effective treatment for glaucoma. However, fibrosis of the outflow site can hamper surgical outcome. In this study, the antifibrotic effect of adding an endplate (with or without microstructured surface topographies) to a microshunt made of poly(styrene-block-isobutylene-block-styrene) is investigated. New Zealand white rabbits are implanted with a control implant (without endplate) and modified implants. Afterward, bleb morphology and IOP is recorded for 30 days. After killing of the animals, eyes are collected for histology, Addition of an endplate extended bleb survival, Topography-990 has the longest recorded bleb-survival time. Histology reveals that the addition of an endplate increases the presence of myofibroblasts, macrophages, polymorphonuclear cells, and foreign body giant cells compared to the control. However, an increased capsule thickness and inflammatory response are observed in the groups with surface topographies, The addition of an endplate results in prolonged bleb survival, demonstrating that engineering of the shape of glaucoma implants could prolong bleb functionality. Future research should further elaborate the effect of surface topographies on long-term bleb survival, since an increased presence of pro-fibrotic cells and increased capsule thickness are observed compared to the control.

Effectiveness and cost-effectiveness of MicroShunt implantation versus standard trabeculectomy for open-angle glaucoma (a SIGHT study): study protocol of a multicentre randomised controlled trial.

BACKGROUND: Trabeculectomy is the "gold standard" initial surgical procedure for open-angle glaucoma worldwide. During the last decade, the introduction of less invasive procedures, including new bleb-forming surgery such as the MicroShunt, has altered the approach of glaucoma management. At present, there is insufficient evidence comparing the effectiveness between these procedures nor versus trabeculectomy. Furthermore, there is no data available on patient impact and cost-effectiveness. This study aims to address this gap in evidence and establish whether MicroShunt implantation is non-inferior compared to trabeculectomy with regard to effectiveness and whether it is cost-effective. METHODS: A multicentre, non-inferiority, randomised controlled trial (RCT) studying open-angle glaucoma with an indication for surgery will be conducted. Patients with previous ocular surgery except for phacoemulsification are excluded, as are patients with ocular comorbidity compromising the visual field or requiring a combined procedure. After informed consent is obtained, patients will be randomly allocated to the intervention, a PRESERFLO™ MicroShunt implantation, or the control group, trabeculectomy, using block randomisation (blocks of 2, 4 or 6 patients). In total, 124 patients will be randomised in a 1:1 ratio, stratified by centre. The primary endpoint will be intraocular pressure (IOP) one year after surgery. Secondary outcomes include IOP-lowering medication use, treatment failure, visual acuity, visual field progression, additional interventions, adverse events, patient-reported outcome measures (PROMs), and cost-effectiveness. Study outcomes will be measured up to 12 months postoperatively. DISCUSSION: This study protocol describes the design of a multicentre non-inferiority randomised controlled trial. To this date, cost-effectiveness studies evaluating the MicroShunt have not been undertaken. This multicentre RCT will provide more insight into whether MicroShunt implantation is non-inferior compared to standard trabeculectomy regarding postoperative IOP and whether MicroShunt implantation is cost-effective. TRIAL REGISTRATION: ClinicalTrials.gov, Identifier: NCT03931564 , Registered 30 April 2019.

Maxillary overdentures supported by four or six implants in the anterior region: 10-year randomized controlled trial results.

AIM: To evaluate bar-supported maxillary implant overdenture treatment when supported by either four or six implants after 10 years. MATERIALS AND METHODS: Edentulous subjects with maxillary denture complaints and ample bone volume to facilitate implants in the anterior region of the maxilla were planned for implant overdenture treatment, randomized to receive either four implants (n = 25) or six implants (n = 25) and subsequently evaluated after 10 years of function. Outcome variables included peri-implant bone-level changes, implant and overdenture survival, complications, presence of plaque, calculus and bleeding, degree of peri-implant inflammation, probing depth and patient satisfaction. Differences between the groups and between evaluation periods were tested with a Student's t-test. RESULTS: Fourteen patients with totally 72 implants were lost to follow-up. Two patients from the six-implant group experienced implant loss (four implants), resulting in 96.1% implant survival in this group versus 100% survival in the four-implant group. Clinical, radiographical and patient-reported outcome measures did not differ statistically significant between the two groups. Patients from both groups were generally quite satisfied with the result after 10 years. CONCLUSIONS: Similar and favourable outcomes are seen in bar-supported maxillary overdentures on either four or six anteriorly placed implants after a 10-year evaluation period.

The performance of two-implant overdentures in the atrophic maxilla: a case series with 1-year follow-up.

PURPOSE: To assess the implant and prosthesis survival rates, the clinical, radiographical and patient-related outcome measures, and the masticatory performance of maxillary overdentures supported by two implants in patients with an atrophic maxilla. METHODS: In this case series, 15 consecutive patients who were eligible for maxillary implant overdenture therapy, but who had insufficient bone volume to place at least four implants and were unwilling to be treated with reconstructive surgery were asked to participate. After giving consent, participants received two implants in the maxilla under local anaesthesia. After 3 months of osseointegration, a maxillary overdenture with palatal coverage and solitary attachments was fabricated. Implant and overdenture survival, marginal bone level change, clinical outcome measures, masticatory performance and patient-related outcomes were evaluated at baseline and 1 year after overdenture placement. RESULTS: Fourteen out of 15 participants completed the follow-up period of 12 months. Implant and overdenture survival rate were 89.3% and 85.7%, respectively. Change in marginal bone level (- 0.5 ± 0.7 mm), change in probing depth (0.0 ± 1.0 mm), and clinical outcomes were favourable. Masticatory performance and patient-related outcomes improved significantly compared to baseline. Complications were minimal. CONCLUSIONS: Within the limitations of this study, it can be concluded that patients with extreme resorption of the maxilla that are unwilling to be treated with reconstructive surgery, benefit from two-implant maxillary overdentures retained by solitary attachments in terms of improved masticatory functioning and denture satisfaction. However, they have relatively high risk of implant loss. TRIAL REGISTRATION: UMCG Trial Register (RR201900060), registered 22 January 2019.

Maxillary bar overdentures on four or six posterior implants: 10-year results from a randomized clinical trial.

OBJECTIVE: To compare clinical and patient-reported outcomes when providing maxillary overdentures on four and six splinted implants placed in the posterior region during a 10-year follow-up period. MATERIALS AND METHODS: Sixty-six edentulous participants with functional maxillary denture complaints and insufficient bone volume to allow implant placement were scheduled for a bone augmentation procedure. After healing, participants were randomized to receive either four or six implants in the posterior maxilla. After 3 months of osseointegration, a bar overdenture was constructed. Implant survival, overdenture survival, clinical scores, peri-implant bone height changes, and patient satisfaction were assessed. RESULTS: Forty-six participants completed the 10-year follow-up. Implant survival was 100% in the 4-implant group and 96.7% in the 6-implant group. Seven new overdentures were made in the 4-implant group and 12 new overdentures were made in the 6-implant group due to excessive wear of the denture base and teeth. Clinical parameters did not differ significantly between groups. Mean marginal bone loss compared to baseline was 0.41 ± 0.37 mm in the 4-implant group and 0.70 ± 1.07 mm in the 6-implant group. Overall, patient satisfaction improved significantly, but did not differ between groups. CONCLUSION: From this 10-year follow-up trial, it was concluded that bar maxillary overdentures on four or six implants in the posterior region of an augmented maxilla resulted in a comparable treatment outcome with high implant survival, limited loss of peri-implant marginal bone, and high patients' satisfaction. (Clinical trial registration number: NTR9729).