| 1. |
- Ruilope, LM, et al.
(författare)
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Design and Baseline Characteristics of the Finerenone in Reducing Cardiovascular Mortality and Morbidity in Diabetic Kidney Disease Trial
- 2019
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Ingår i: American journal of nephrology. - : S. Karger AG. - 1421-9670 .- 0250-8095. ; 50:5, s. 345-356
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Tidskriftsartikel (refereegranskat)abstract
- <b><i>Background:</i></b> Among people with diabetes, those with kidney disease have exceptionally high rates of cardiovascular (CV) morbidity and mortality and progression of their underlying kidney disease. Finerenone is a novel, nonsteroidal, selective mineralocorticoid receptor antagonist that has shown to reduce albuminuria in type 2 diabetes (T2D) patients with chronic kidney disease (CKD) while revealing only a low risk of hyperkalemia. However, the effect of finerenone on CV and renal outcomes has not yet been investigated in long-term trials. <b><i>Patients and</i></b> <b><i>Methods:</i></b> The Finerenone in Reducing CV Mortality and Morbidity in Diabetic Kidney Disease (FIGARO-DKD) trial aims to assess the efficacy and safety of finerenone compared to placebo at reducing clinically important CV and renal outcomes in T2D patients with CKD. FIGARO-DKD is a randomized, double-blind, placebo-controlled, parallel-group, event-driven trial running in 47 countries with an expected duration of approximately 6 years. FIGARO-DKD randomized 7,437 patients with an estimated glomerular filtration rate ≥25 mL/min/1.73 m<sup>2</sup> and albuminuria (urinary albumin-to-creatinine ratio ≥30 to ≤5,000 mg/g). The study has at least 90% power to detect a 20% reduction in the risk of the primary outcome (overall two-sided significance level α = 0.05), the composite of time to first occurrence of CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure. <b><i>Conclusions:</i></b> FIGARO-DKD will determine whether an optimally treated cohort of T2D patients with CKD at high risk of CV and renal events will experience cardiorenal benefits with the addition of finerenone to their treatment regimen. Trial Registration: EudraCT number: 2015-000950-39; ClinicalTrials.gov identifier: NCT02545049.
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| 2. |
- Esposito, Marco, 1965, et al.
(författare)
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Clinical evaluation of a novel dental implant system as single implants under immediate loading conditions-4-month post-loading results from a multicentre randomised controlled trial
- 2016
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Ingår i: European Journal of Oral Implantology. - 1756-2406. ; 9:4, s. 367-379
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Tidskriftsartikel (refereegranskat)abstract
- Purpose: To evaluate the safety and clinical effectiveness of a novel dental implant system (GENESIS Implant System, Keystone Dental, Massachusetts, USA) using another dental implant system by the same manufacturer as a control (PRIMA Implant System, Keystone Dental). Materials and methods: A total of 53 patients requiring at least two single crowns had their sites randomised according to a split-mouth design to receive both implant systems at six centres. If implants could be placed with a torque superior to 40 Ncm they were to be loaded immediately with provisional crowns, otherwise after 3 months of submerged healing. Provisional crowns were replaced by definitive crowns 4 months after initial loading, when the follow-up period for the initial part of this study was completed. Outcome measures were crown/implant failures, complications, pink esthetic score (PES), peri-implant marginal bone level changes, plaque score, marginal bleeding, patients and preference of the clinician. Results: In total 53 PRIMA and 53 GENESIS implants were placed. Three patients dropped out but all of the remaining patients were followed up to 4-months post-loading. No PRIMA implant failed whereas four GENESIS implants failed. Only two complications were reported for PRIMA implants. There were no statistically significant differences for crown/implant failures (difference in proportions = 0.080; P (McNemar test) = 0.125) and complications (difference in proportions = -0.04; P (McNemar test) = 0.500) between the implant systems. There were no differences at 4-months post-loading for plaque (difference = -0.54, 95% CI:-3.01 to 1.93; P (Paired t-test) = 0.660), marginal bleeding (difference = -3.8, 95% CI: -7.63 to 0.019; P (Paired t-test) = 0.051), PES (difference = 0.47, 95% CI:-0.56 to 1.50; P (Paired t-test) = 0.365) and marginal bone level changes (difference in mm = -0.04, 95% CI: -0.33 to 0.26; P (Paired t-test) = 0.795). The majority of the patients (46) had no preference regarding the two implant systems evaluated. Three operators preferred GENESIS implants, two had no preference and one preferred GENESIS in medium and soft bone and PRIMA in hard bone. Conclusions: No statistically significant differences were observed between the systems' implant types, although four GENESIS implants failed versus none of the PRIMA type. Longer follow-ups of wider patient populations are needed to better understand whether there is an effective advantage with one of the two implant designs.
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| 3. |
- Esposito, Marco, 1965, et al.
(författare)
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Immediate, immediate-delayed (6 weeks) and delayed (4 months) post-extractive single implants: 1-year post-loading data from a randomised controlled trial
- 2017
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Ingår i: European Journal of Oral Implantology. - 1756-2406. ; 10:1, s. 11-26
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Tidskriftsartikel (refereegranskat)abstract
- Purpose: To compare the clinical outcome of single implants placed immediately after tooth extraction with implants placed 6 weeks after tooth extraction (immediate-delayed placement), and with implants placed after 4-month extraction and socket healing (delayed placement). Materials and methods: Two-hundred and ten (210) patients requiring a single implant-supported crown to replace a tooth to be extracted were randomised to receive immediate post-extractive implants (70 patients), immediate-delayed implants at 6 weeks (70 patients), and delayed implants after 4 months of healing (70 patients) according to a parallel group design. When needed, patients of the immediate and immediate-delayed group had the socket grafted with a bone substitute and covered with a resorbable membrane at implant placement. Sockets randomised to delayed implants were grafted in the same manner if poorly preserved or in the aesthetic areas (from second upper to second upper premolars). Implants inserted with at least 25 Ncm torque were left to heal unloaded for 4 months, whereas those inserted with less than 25 Ncm were left to heal unloaded for 6 months. Temporary crowns were delivered and were to be replaced by definitive ones after 4 months. Outcome measures were crown and implant failures, complications, peri-implant marginal bone level changes, aesthetically assessed using the pink esthetic score (PES), and patient satisfaction recorded by blinded assessors. Patients were followed up to 1 year post-loading. Results: One year after loading, three patients dropped out from the immediate group, five from the immediate-delayed group, and six from the delayed group. Four implants (6%) failed in the immediate, four (6.2%) in the immediate-delayed, and one (1.6%) from the delayed group (P (chisquare test) = 0.369). Apart from the crowns (which failed due to implant losses), no other crown had to be remade. Six immediate, six immediate-delayed and four delayed implants were affected by one complication each (P (chi-square test) = 0.792). Mean peri-implant marginal bone loss after 1 year was-0.25 +/- 0.17 mm (CI 95%-0.29; -0.20) at immediate,-0.29 +/- 0.14 mm (CI 95% -0.32; -0.25) at immediate-delayed, and-0.31 +/- 0.16 mm (Cl 95%-0.35; -0.27) at delayed placed implants (P (Kruskal-Wallis test) = 0.015). One year after loading, the mean total aesthetic score was 12.52, 12.49 and 11.78 at the immediate, immediate-delayed and delayed groups, respectively (P (Kruskal-Wallis test) < 0.001). All patients were fully satisfied both with function and aesthetics, and would undergo the same procedure again, with four exceptions (one from the immediate, one from the immediate-delayed and two from the delayed group), who were only partially satisfied with aesthetics (P = 0.785). Conclusions: No statistically significant differences for failures, complications and patient satisfaction were observed when placing single implants immediately, 6 weeks or 4 months after tooth extraction; nevertheless, failures were more frequent at immediate and immediate-delayed placed implants. Bone level changes were similar between the different procedures, but aesthetics were better results at immediate and immediate-delayed implants.
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| 4. |
- Felice, P., et al.
(författare)
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Immediate, immediate-delayed (6 weeks) and delayed (4 months) post-extractive single implants: 4-month post-loading data from a randomised controlled trial
- 2016
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Ingår i: European Journal of Oral Implantology. - 1756-2406. ; 9:3, s. 233-247
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Tidskriftsartikel (refereegranskat)abstract
- Purpose: To compare the clinical outcome of single implants placed immediately after tooth extraction with implants placed 6 weeks after tooth extraction (immediate-delayed placement), and with implants placed after 4 months of extraction and socket healing (delayed placement). Materials and methods: Two hundred and ten patients requiring a single implant-supported crown to replace a tooth to be extracted were randomised to receive immediate post-extractive implants (70 patients), immediate-delayed implants at 6 weeks (70 patients), and delayed implants after 4 months of healing (70 patients), according to a parallel group design. When needed, patients of the immediate and immediate-delayed group had the socket grafted with a bone substitute and covered with a resorbable membrane at implant placement. Sockets randomised to delayed implants were grafted in the same manner if poorly preserved or in the aesthetic areas (from second upper to second upper premolars). Implants inserted with at least 25 Ncm torque were left to heal unloaded for 4 months, whereas those inserted with less than 25 Ncm were left to heal unloaded for 6 months. Temporary crowns were delivered and were to be replaced by definitive ones after 4 months. Outcome measures were crown and implant failures, complications, periimplant marginal bone level changes, aesthetics assessed using the pink esthetic score (PES) and patient satisfaction recorded by blinded assessors. Results: Three patients dropped out from the immediate, five from the immediate-delayed and six from the delayed group up to 4-months post-loading. Four implants (6.0%) failed in the immediate, four (6.2%) in the immediate-delayed and one (1.6%) from the delayed group (P (chi-square test) = 0.369). Apart from the crown failures due to implant losses, no other crown had to be remade. Five immediate, six immediate-delayed and three delayed implants were affected by one complication each (P (chi-square test) = 0.601). Mean peri-implant marginal bone loss after 4 months was -0.17 +/- 0.11 mm (95% CI: -0.20; -0.15) at immediate, -0.20 +/- 0.09 mm (95% CI: -0.23; -0.18) at immediate-delayed, and -0.24 +/- 0.12 mm (95% CI: -0.27; -0.21) at delayed placed implants (P (Kruskal Wallis test) = 0.006). At delivery of definitive crowns, 4 months after loading, the mean total aesthetic score was 12.48, 12.38 and 11.71 in the immediate, immediate-delayed and delayed groups, respectively (P (Kruskal Wallis test) < 0.001). All patients were fully satisfied with both function and aesthetics, and would undergo the same procedure again, with four exceptions (one from the immediate, one from the immediate-delayed and two from the delayed group), who were partially satisfied with the aesthetics (P = 0.785). Conclusions: No statistically significant differences for failures, complications and patient satisfaction were observed when placing single implants immediately, 6 weeks or four months after tooth extraction; nevertheless failures and complications were more frequent for immediate and immediate-delayed placed implants. Bone level changes were similar between the different procedures, but the aesthetics showed better results for immediate and immediate-delayed implants.
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| 5. |
- Cannizzaro, G., et al.
(författare)
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Immediate loading of two (fixed-on-2) versus three (fixed-on-3) implants placed flapless supporting cross-arch fixed prostheses: One-year results from a randomised controlled trial
- 2016
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Ingår i: European Journal of Oral Implantology. - 1756-2406. ; 9:2, s. 143-153
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Tidskriftsartikel (refereegranskat)abstract
- Purpose: To evaluate the outcome of two (fixed-on-2 = FO2) versus three (fixed-on-3 = FO3) implants placed flapless in fully edentulous jaws and immediately restored with metal-resin screw-retained crossarch prostheses. Materials and methods: Forty edentulous or to be rendered edentulous patients (20 in the maxilla and 20 in the mandible) were randomised to the FO2 group (20 patients: 10 in the maxilla and 10 in the mandible) and to the FO3 group (20 patients: 10 in the maxilla and 10 in the mandible) according to a parallel group design. To be immediately loaded, implants had to be inserted with a minimum torque of 60 Ncm. Outcome measures were prosthesis and implant failures, complications and peri-implant marginal bone level changes evaluated up to 1-year post-loading. Results: Flaps were raised in four patients and two prostheses were loaded early at 8 weeks in the FO2 group. One year after loading no dropout or implant failure occurred, however one FO2 maxillary prosthesis had to be remade because of repeated screw-loosening (risk difference = 0.05; 95% CI: -0.05 to 0.15; Fisher's exact test P = 1.000). Three FO2 patients were affected by complications versus five FO3 patients (risk difference = -0.1; 95% CI: -0.35 to 0.15; Fisher's exact test; P = 0.695). There were no statistically significant differences for prosthetic failures and complications between groups. There were no statistically significant differences for marginal peri-implant bone levels between the two groups (estimate of the difference = 0.031 mm; 95% Cl: -0.22 to 0.28; P (ancova) = 0.803), with both groups losing marginal bone in a statistically significant way (0.27 mm for FO2 patients and 0.24 mm for FO3 patients). Conclusions: These preliminary results suggest that immediately loaded cross-arch prostheses can be supported by only two or three dental implants at least up to 1-year post-loading. Longer follow-ups are needed to properly evaluate both these therapeutic options.
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| 6. |
- Cannizzaro, G., et al.
(författare)
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Immediate loading of two (fixed-on-2) vs four (fixed-on-4) implants placed with a flapless technique supporting mandibular cross-arch fixed prostheses: 3-year results from a pilot randomised controlled trial
- 2017
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Ingår i: European Journal of Oral Implantology. - 1756-2406. ; 10:2, s. 133-145
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Tidskriftsartikel (refereegranskat)abstract
- Purpose: To evaluate the outcome of two vs four implants placed flapless in fully edentulous mandibles and immediately restored with metal-resin screw-retained cross-arch prostheses. Materials and Methods: A total of 60 patients from two different centres were randomised: 30 to the fixed-on-2 group and 30 to the fixed-on-4 group according to a parallel group design. To be immediately loaded implants had to be inserted with a minimum torque of 40 Newton/cm (Ncm). Outcome measures were prosthesis and implant failures, complications, and marginal bone level changes. Results: Flaps were raised in 18 patients. Two implants in two patients did not reach the planned insertion torque and were replaced immediately by larger diameter ones. Three years after loading, two patients dropped out from the fixed-on-2 group and one from the fixed-on-4 group. No implant failure or prosthetic failure occurred. A total of 12 fixed-on-2 patients were affected by one complication each vs 13 fixed-on-4 patients. There were no statistically significant differences for complications between groups (difference in proportion = -0.03; 95% CI -29 to 0.22; P [Fisher's exact test] = 1.000). There were no statistically significant differences for marginal peri-implant bone loss between the two groups (mean difference = 0.14; CI 95% -0.17 to 0.45; P [ANCOVA] = 0.356), with both groups losing marginal bone in a statistically significant way (1.70 mm for fixed-on-2 implants and 1.56 mm for fixed-on-4 implants). There were statistically significant differences between the two centres, with more bone being lost for the Bologna centre (2.18 vs 1.13 mm; P (ANCOVA) < 0.001). Conclusions: Up to 3 years after loading, these preliminary results suggest that immediately loaded mandibular cross-arch fixed prostheses can be supported by only two dental implants. Longer follow-ups (about 10 years) are needed to properly evaluate this therapeutic option.
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| 7. |
- Cannizzaro, G., et al.
(författare)
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Immediate loading of two flapless placed mandibular implants supporting cross-arch fixed prostheses: A 5-year follow-up prospective single cohort study
- 2016
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Ingår i: European Journal of Oral Implantology. - 1756-2406. ; 9:2, s. 165-177
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Tidskriftsartikel (refereegranskat)abstract
- Purpose: To evaluate the clinical outcome of two implants placed flapless in fully edentulous mandibles and immediately restored with metal-resin screw-retained cross-arch prostheses 5 years after loading. Materials and methods: Eighty consecutive patients were recruited. To be immediately loaded, implants had to be inserted with a minimum torque of 80 Ncm. Forty-six laser-welded titanium and 34 cast silver-palladium frameworks with resin teeth were initially delivered within 8 and 48 h, respectively. Outcome measures, evaluated by two independent assessors included prosthesis and implant failures, complications, marginal bone level changes, implant stability quotient (ISQ) values and patient satisfaction. Results: Five years after loading one patient did not return to the control and 10 prostheses were remade. Two implants failed early in two patients, but they were successfully replaced. Thirty-six complications occurred in 28 patients but were all successfully treated. After 5 years, mean marginal bone loss was 0.69 mm, mean ISQ values decreased from 75.4 to 73.8, and all patients were fully satisfied with the therapy. A post-hoc comparison between the outcome of laser-welded and cast frameworks showed that laser-welded frameworks were affected by significantly more complications (19 patients out of 46 and 6 patients out of 34, respectively; difference in proportion = 0.23, 95% CI: 0.03 to 0.43; Pearson's chi-square test, P = 0.032), therefore such a framework construction should be considered as a long-term temporary prosthesis and not a definitive prosthesis. Conclusions: Immediately loaded mandibular cross-arch prostheses can be supported by only two implants up to 5 years, if made with a robust cast framework. Longer follow-ups (around 10 years) are still needed to know the prognosis of this treatment modality.
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| 8. |
- Cannizzaro, G., et al.
(författare)
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Machined versus roughened immediately loaded and finally restored single implants inserted flapless: Preliminary 6-month data from a split-mouth randomised controlled trial
- 2016
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Ingår i: European Journal of Oral Implantology. - 1756-2406. ; 9:2, s. 155-163
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Tidskriftsartikel (refereegranskat)abstract
- Purpose: To compare the outcome of immediately loaded single implants with a machined or a roughened surface. Materials and methods: Fifty patients had two implant sites randomly allocated to receive flapless-placed single Syra implants (Sweden & Martina), one with a machined and one with a roughened surface (sand-blasted with zirconia powder and acid etched), according to a split-mouth design. To be loaded immediately, implants had to be inserted with a torque superior to 50 Ncm. Implants were restored with definitive crowns in direct occlusal contact within 48 h. Patients were followed for 6 months after loading. Outcome measures were prosthetic and implant failures and complications. Results: Two machined implants and four roughened implants were not loaded immediately. Six months after loading no dropout occurred. One implant loaded late, which had a rough implant surface, failed 20 days after loading (P (McNemar test) = 0.625; difference in proportions = -0.04; 95% CI: -0.15 to 0.07). Three crowns had to be remade on machined implants and four on roughened implants (P (McNemar test) = 1.000; difference in proportions = -0.02; 95% CI: -0.12 to 0.08). Three machined and five roughened implants experienced complications (P (McNemar test) = 0.625; difference in proportions = -0.04; 95% CI: -0.15 to 0.07). There were no statistically significant differences between groups for crown and implant losses as well as complications. Conclusions: Up to 6 months after loading both machined and roughened flapless-placed and immediately loaded single implants provided good and similar results, however, longer follow-ups are needed to evaluate the long-term prognosis of implants with different surfaces.
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| 9. |
- Esposito, Marco, 1965, et al.
(författare)
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Dental implants with internal versus external connections: 5-year post-loading results from a pragmatic multicenter randomised controlled trial
- 2016
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Ingår i: European Journal of Oral Implantology. - 1756-2406. ; 9:2, s. 129-141
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Tidskriftsartikel (refereegranskat)abstract
- Purpose: To evaluate advantages and disadvantages of identical implants with internal or external connections. Materials and methods: One hundred and twenty patients with any type of edentulism (single tooth, partial and total edentulism), requiring one implant-supported prosthesis were randomly allocated in two equal groups to receive either implants with an external connection (EC) or implants of the same type with an internal connection (IC) (EZ Plus, MegaGen Implant, Gyeongbuk, South Korea), at four centres. Due to slight differences in implant design and components, IC implants were platformswitched while EC were not. Patients were followed for 5 years after initial loading. Outcome measures were prosthesis/implant failures, any complication, marginal bone level changes and clinician preference, assessed by blinded outcome assessors. Results: Sixty patients received 96 EC implants and 60 patients received 107 IC implants. Three patients dropped out with four EC implants and five patients with ten IC implants, but all remaining patients were followed up to 5-year post-loading. One prosthesis supported by EC implants and two by IC implants failed (P = 0.615, difference = -0.02, 95% CI: -0.08 to 0.04). One EC implant failed versus three IC implants in two patients (P = 0.615, difference = -0.02, 95% CI: -0.08 to 0.04). Ten complications occurred in 10 EC patients versus nine complications in 9 IC patients (P = 1.000, difference = 0.01, 95% CI: -0.13 to 0.15). There were no statistically significant differences for prosthesis and implant failures and complications between the different connection types. Five years after loading, there were no statistically significant differences in marginal bone level estimates between the two groups (difference = 0.14 mm, 95% CI: -0.28 to 0.56, P (ancova) = 0.505) and both groups lost bone from implant placement in a statistically significant way: 1.13 mm for the EC implants and 1.21 mm for the IC implants. Two operators had no preference and two preferred IC implants. Conclusions: Within the limitations given by the difference in neck design and platform switching between EC and IC implants, 5-year post-loading data did not show any statistically significant differences between the two connection types, therefore clinicians could choose whichever they preferred.
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| 10. |
- Esposito, Marco, 1965, et al.
(författare)
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Four mm-long versus longer implants in augmented bone in atrophic posterior jaws: 4-month post-loading results from a multicentre randomised controlled trial
- 2016
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Ingår i: European Journal of Oral Implantology. - 1756-2406. ; 9:4, s. 393-409
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Tidskriftsartikel (refereegranskat)abstract
- Purpose: To evaluate whether 4-mm long dental implants could be an alternative to augmentation with equine bone blocks and the placement of at least 10-mm long implants in atrophic posterior jaws. Materials and methods: Forty patients with atrophic posterior (premolar and molar areas) mandibles having 5 to 6 mm bone height above the mandibular canal and 40 patients with atrophic maxillae having 4 to 5 mm below the maxillary sinus, were randomised according to a parallel group design to receive one to three 4.0 mm-long implants or one to three implants, which were at least 10 mm long, in augmented bone at two centres. All implants had a diameter of 4.0 or 4.5 mm. Mandibles were vertically augmented with interpositional equine bone blocks and resorbable barriers. Implants were placed 4 months after interpositional grafting. Maxillary sinuses were augmented with particulated porcine bone via a lateral window covered with resorbable barriers, and implants were placed simultaneously. Implants were not submerged and were loaded after 4 months with provisional prostheses. Four months later, screw-retained reinforced acrylic restorations were delivered, and then replaced after 4 months by definitive screw-retained metal-composite prostheses. Patients were followed up to 4-months post-loading. Outcome measures included prosthesis and implant failures, any complication and peri-implant marginal bone level changes. Results: No patient dropped out. In six augmented mandibles (30%), it was not possible to place implants which were at least 10.0-mm long, therefore shorter implants had to be placed instead. In particular, one mandible fractured and the patient did not want to go ahead with the treatment. One implant of the patient with the mandible fracture from the augmented group failed versus two 4.0 mm implants in two patients from the short implant group. In the maxillae, three short implants failed in two patients versus five long implants in three patients (two long implants and one short implant dropped into the maxillary sinus). Two prostheses on short implants (one mandibular and one maxillary) were placed at a later stage because of implant failures versus four prostheses (one mandibular and three maxillary) at augmented sites. In particular, three patients of the augmented group (one mandible and two maxillary) were not prosthetically rehabilitated. There were no statistically significant differences in implant failures (P (chi-square test) = 1.000; difference in proportion = 0; 95% CI:-0.13 to 0.13 or prostheses failures (P (chi-square test) = 0.399; difference in proportion = 0.05; 95% CI:-0.06 to 0.16). At mandibular sites, nine augmented patients were affected by complications versus one patient treated with short implants (P (chi-square test) = 0.003; difference in proportion = 0.40; 95% CI: 0.16 to 0.64), with the difference being statistically significant. No significant differences were found for the maxillae: eight sinus lift patients versus three patients rehabilitated with maxillary short implants were affected by complications (P (chi-square test) = 0.077; difference in proportion = 0.25; 95% CI:-0.02 to 0.52). Patients with mandibular short implants lost on average 0.40 mm of peri-implant bone at 4 months and patients with 10 mm or longer mandibular implants lost 0.52 mm. Patients with short maxillary implants lost on average 0.48 mm peri-implant bone at 4 months and patients with 10 mm or longer maxillary implants lost 0.50 mm. The difference was statistically significant in the mandibles (mean difference: -0.12 mm, 95% CI: -0.20 to -0.04, P (ANCOVA) = 0.006), but not in the maxillae (mean difference: -0.02 mm, 95% CI: -0.10 to 0.07, P (ANCOVA) = 0.711). Conclusions: Four months after loading 4.0 mm-long implants achieved similar results, if not better, than longer implants in augmented jaws, but were affected by fewer complications. Short implants might be a preferable choice to bone augmentation, especially in mandibles, since the treatment is less invasive, faster, cheaper, and associated with less morbidity; however, 5- to 10-year post-loading data is necessary before making reliable recommendations.
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