| Abstract|| |
Purpose: This systematic review has been undertaken to highlight the unforgettable contributions of Prof. Brånemark Per-Ingvar (PI). It could be understood that reviewing his work would give an idea of growth of this treatment modality. Materials and Methods: An electronic search on the PubMed/Medline, Ebscohost, and Cochrane database was done using search term “Brånemark PI” to identify his publications. Articles published in English and only related to implants and osseointegration were included. Screening of the titles and abstracts were done according to inclusion criteria and suitable studies were included in the review. Results: The initial literature search resulted in 187 articles, out of which 92 articles were excluded due to not meeting the inclusion criteria and 16 articles excluded due to non-availability of even abstract also. A total of 79 articles were finally included in this review. Conclusion: Brånemark PI had a great vision of future; who considered edentulism as equal to amputation and came up with the concept of osseointegrated implants to overcome them. The innovations of Brånemark had assured the world that it is very much possible to provide implant-supported prosthesis in any situations for the rehabilitation of the individuals.
Keywords: Per-Ingvar Brånemark, Brånemark system implants, osseointegration, osseoperception
|How to cite this article:|
Mishra SK, Chowdhary R. Evolution of dental implants through the work of per-ingvar branemark: A systematic review. Indian J Dent Res 2020;31:930-56
|How to cite this URL:|
Mishra SK, Chowdhary R. Evolution of dental implants through the work of per-ingvar branemark: A systematic review. Indian J Dent Res [serial online] 2020 [cited 2022 May 22];31:930-56. Available from: https://www.ijdr.in/text.asp?2020/31/6/930/311662
| Introduction|| |
Per-Ingvar Brånemark, was born on 3rd May 1929 in Karlshamn, Sweden. In 1956, he received his doctoral degree from the University of Lund in Sweden. Three years later, he successfully defended his Ph.D. thesis on Vital Microscopy of Bone Marrow in Rabbit. In 1952, when he was studying the flow of blood in rabbit femur by placing titanium chambers in their bone, he found that these titanium chambers were firmly affixed to bone and cannot be removed without breaking the bone. This unforeseen event had laid down the foundation of osseointegration and whole world recognized him as the father of the modern dental implant.
Edentulism came to his attention early on in his career. The first dental implants that he placed remained in place for over 40 years. It took years for Brånemark PI to convince the world that titanium could be integrated into living tissue. In 1978, his design was approved by Sweden's National Board of Health and Welfare., After 40 years of discovery of osseointegration he was issued the U.S. Patent No. 4988299, entitled Implant Fixture for Tooth Prosthesis.
At a professional meeting in Toronto in 1982, Brånemark had made the case of osseointegration and had won widespread recognition. The European Association for Osseointegration (EAO) came into being in 1990. Branemark won many awards for his remarkable work with osseointegration.
Branemark's two-stage system has been universally used since then. He stated that bone cell and its surrounding matrix does not know the role of the implant that it is supporting.
His work has revolutionized the treatment of complete and partial edentulous patients as well as the rehabilitation of patients with maxillofacial defects.,,
This systematic review on Prof. Brånemark PI was undertaken to highlight his innovations and literature contribution toward implants and osseointegration, which can tell the readers from the process to practice of this treatment modality.
| Materials and Methods|| |
Search strategies and other information
The present systematic review was based on the PRISMA guidelines. An electronic search without any restrictions of time was undertaken in January 2018 in the PubMed/Medline, Ebscohost, Cochrane databases. The term searched was “Brånemark PI.”
Inclusion and exclusion criteria
Articles authored or co-authored by Brånemark PI were only included. Articles published in English and only related to implants and osseointegration were included. Considering the value of this review, the articles whose abstract was available in English were also included. Screening of the titles and abstracts were done according to inclusion criteria and the literature that fulfilled it was included in the review. The article not authored or co-authored by Brånemark PI and not related to implants and osseointegration, or non-availability of abstract and not in English was excluded.
The titles and abstracts of all reports identified through the electronic searches were read independently by two reviewers and any disagreement regarding inclusion or exclusion of selected articles was resolved by a discussion between reviewers.
From the studies included in the final analysis, the following data were extracted (when available): Author, year of publication, number of subjects, age, number of implants and its type, years of follow up, type of prosthesis, number of implants failed, marginal bone loss, success rate, and inference.
| Results|| |
The initial literature search resulted in 187 articles, out of which 108 articles were excluded. About 92 articles were excluded as they were not in English and not fulfilling the inclusion criteria [Figure 1]. Sixteen articles were excluded, as their abstract was also not available in English language. A total of 79 articles finally included in this systemic review. Detailed data of the 79 articles were listed in [Table 1],,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,, as articles published by Brånemark and colleagues on intraoral applications of osseointegrated implants and [Table 2],,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,, as articles published by Brånemark and colleagues on applications of osseointegrated implants in extraoral prosthesis, joint prosthesis, and in other animal studies.
|Figure 1: Flowchart presented the screening of articles to be included in the present review|
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|Table 1: Articles published by Brånemark and colleagues on intraoral applications of osseointegrated implants|
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|Table 2: Articles published by Brånemark and colleagues on applications of osseointegrated implants in extraoral prosthesis, joint prosthesis and in other animal studies|
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| Discussion|| |
The term “Osseointegration” was coined by Brånemark PI in 1977. He described osseointegration as the fixation of implants without cement, be it by means of smooth, porous, metallic, or ceramic surfaces, is based on the regeneration of mature, living bone in direct contact with the implant surface, without an intervening soft tissue membrane. Initially the principle of osseointegration was introduced for the treatment of completely edentulous patients, and later it was adapted to retain the prostheses anywhere in the body wherever vital bone remodeling was possible. Today, endosseous implants manufactured from titanium and its alloys are used regularly for dental and orthopedic prostheses. At the Harvard Conference it was suggested that the only method to rehabilitate edentulous patients is through osseointegration. The principle reasons in favor of this phenomenon were: 1. a biological seal is established around the abutments beneath the soft tissue which prevents inflammatory reactions around the implant and 2. there is establishment of osseointegration.
Establishment of osseointegration depends on implant material, design and finish of implant, status of the bone, surgical technique, and loading conditions of implant. There are three mechanisms through which implant fixtures and haversian bone may be lost: 1. occurrence of initial healing with a soft tissue capsule. 2. Due to repeated loading leading to loss of osseointegration achieved initially. 3. The anchorage of fixture is deprived of bone support due to gradual apical migration of the marginal bone gradually.
A direct bone contact with implants is not a guarantee for long-term implant success. The quality of bone preferably in form of haversian bone instead of woven bone is very important at the interface.
First demonstration of osseointegration in mice was shown by Rahal et al., in their work utilizing miniaturized titanium implants placed into the femoral diaphysis. Albrektsson et al., had found enough evidence of osseointegration at the electron microscope level in a 15 years follow-up study done on 2895 implants. Brånemark et al., had done a 16 years follow-up study on 3250 titanium implants for the rehabilitation of edentulous patients. They had found a direct evidence of osseointegration with anchorage of the implants in living bone without interposing of soft tissues. On rehabilitation of edentulous patients with standard Brånemark implant-supported fixed prostheses in 4636 patients, success rate of 78% in maxillary fixtures, and 86% in mandibular fixtures were found in 15 years of follow up.
Brånemark ad modum concept
This concept of fixed prosthesis was developed by Brånemark PI and offers a reliable treatment option since 1980s. Edentulousness in one or both jaws was rehabilitated by means of 4 or 6 two-staged pure titanium screw-shaped implants. Although tendency exist for an increased failure rate in patients with only four implants, the survival rate for both individual implants, and prostheses was same in both the groups (88.4% and 80.3% on four implants and 93.2% and 78.3% on six implants in mandible and maxilla, respectively).
Brånemark Novum concept
In 1996, Brånemark Novum concept was introduced by Brånemark and colleagues with the aim of reducing the clinical visits so as to reduce the total treatment time and to provide treatment at a very low cost. In this concept, a complete fixed mandibular prosthesis is immediately loaded and supported by three implants (two distal implants next to the foramina and a single central implant at the midline) which are joined together with a metal infrastructure., First patient received a permanent fixed mandibular prosthesis on the same day of surgery with the Brånemark Novum concept (Nobel Biocare, Göteborg, Sweden) in May 1997.
Rivaldo et al., found 97.97% success in 33 patients and Brånemark et al., found 98% success in 50 patients rehabilitated with the Brånemark Novum concept. The bone loss was found to be similar to the prostheses supported by more numbers of implants. Engstrand et al., found 95.0% success in 1 year (94 patients), 93.3% in 3 years (47 patients), and 93.3% in 5 years (9 patients) rehabilitated with the Brånemark Novum concept.
The implant system and prosthesis was perceived as an integrated part of the body as claimed by the participants in a study. Implants with prosthesis should be offered as a solution for those with failed removable dentures.
CeraOne-single tooth replacement
The trial of the CeraOne implant (Nobel Biocare, Göteborg, Sweden) clinically started in February 1989. CeraOne consists of the prefabricated components and a mechanical torque driver along with a gold screw and a counter-torque device. This concept prevents screw loosening and provides better esthetics even in situations with unfavorable implant placement., In a study on 32 patients with 35 single tooth restorations, found that none of the gold screws have loosened. One loose titanium screw after 12 months when replaced with a gold screw showed no further problem. Similar results were obtained in another study wherein it was used on 57 patients with 65 single tooth restorations.
Brånemark concept of zygoma implants
In 1980s, zygoma implant concept to provide support and rehabilitation of craniofacial defects with artificial prostheses was introduced by Prof. Brånemark. Custom-made longer implants were placed from the buttress zone and passing through the maxillary sinus to the zygoma (non-defect sites) to provide functional rehabilitation by creating effective retention in anatomic areas that might otherwise be unsuitable for implant placement without grafting.
The zygomatic implant (Nobel Biocare, Göteborg, Sweden) serves as an excellent substitute for rehabilitation in patients with tumor resection, traumas, cleft palate, patients with large maxillary defects, severely resorbed maxillae, and in cases where grafting procedure was failed. Cross-arch stabilization for the effective axial loading of the zygoma implant can be obtained by a rigid splint framework with minimum four implants with presence of enough anterior–posterior spread. The head of the zygoma implant has been designed to allow prosthesis attachment at a 45° angle to the long axis of the implant. Brånemark PI has recommended not to use the zygoma implant for the rehabilitation of unilateral maxilla. Zygomatic implant concept reduces the surgical morbidity and cost of the treatment. A risk of postoperative sinusitis and injury to orbit is always there. A more complex restorative design is needed due to the palatal location of the implants.
In follow-up cases rehabilitated with zygomatic implants, Duarte et al., found an implant survival rate of 95.83% in 30 months follow up, Hirsch et al. reported 97.9% in 1-year follow up, Kahnberg et al., 96.3% in 3 years, and Brånemark et al. reported 94% in up to 10 years follow up. Authors concluded that zygomatic bone implants can be placed with good clinical success when multicortical stabilization is required.
Brånemark system short implants in severely resorbed maxilla and mandible
The smallest Brånemark implant needs at least 7 mm × 4 mm of bone for initial stability of the fixture. Brånemark short fixtures are usually not recommended in severely resorbed maxillae without bone graft. Patients with severely resorbed maxillae can be rehabilitated with immediate corticocancellous autogenous grafts for a healing period of 8 months and later rehabilitated with implant-supported prostheses. In cases of extreme resorption, supraperiosteal loading of the implant by the denture often leads to a negative bone remodeling and causes increased resorption of the graft. In such cases the support to an autologous free bone graft is provided by self-tapping titanium implants, a technique given by Breine and Brånemark. This immediate fixation with implant provides better co-adaptation to the graft and helps small blood vessels to grow into the graft.,
Astrand et al. found 75% success rate in patients with atrophic maxilla rehabilitated with onlay bone graft and endosteal implants after 3 years of follow up. Adell et al., found 82.1% and van Steenberghe et al., found 95% success in similar studies with 10-year follow up. Atrophic mandible was reconstructed with the Brånemark short implants without any augmentation procedures and showed 92.3% success rate in >10 years of follow-up. Mentioned approach reported as a better treatment option in severely atrophied mandible.
Implant-supported auricular prosthesis
Patients usually present with missing external ear due to congenital defects, hereditary, post-traumata, or resection of tumors. Gothenburg University of Sweden had evolved a technique to rehabilitate auricular defects with osseointegrated titanium implants in temporal bone, and abutment attached to it provides retention to the auricular prosthesis with snap-on attachment. Tjellström et al., found 100% success of auricular prosthesis in follow-up studies of 3 months period and 3 years 6 months period. No problems reported with the bone anchorage or the skin penetration of titanium fixture. In another study by Tjellström et al., only one implant failure was reported in 1–5-year follow up with a success rate of 99.37%. Tjellström et al. do not found any adverse tissue reaction around percutaneus titanium implants osseointegrated in the temporal bone in a 5-year study in 20 patients rehabilitated with bone-anchored episthesis. Curi et al., found 94.1% success of auricular prosthesis for a follow up of 2 years in 17 patients.
Bone-anchored hearing aids
In 1977, Brånemark and Albrekttsson introduced craniofacial implants to be placed percutaneously to be used with bone conduction hearing aids. The bone vibration transducer of the hearing aid is placed on to the skin over the mastoid process and it helps in transmitting sound through soft tissue and bone to the cochlea. The discomfort to the patient due to pressure created on transducer was overcome by permanent implantation of the bone-anchored hearing aid beneath the skin and it also gives a favorable cosmetic result to the patients.,, Tjellström et al.,,, in their 53 months, 2–4 years, and 5 years follow-up studies on patients using external hearing aids reported improved hearing with favorable cosmetic results and absence of any infections. New system has improved pure-tone hearing threshold by about 15 dB with no adverse tissue reactions. Brånemark and Albrektsson in their study of 38–50 months with external hearing aids found good functioning of transcutaneous implants without any problems. Albrektsson et al. found a success rate of 85.3% in irradiated bone and 99.7% in non-irradiated bone in 174 patients rehabilitated with external hearing aid.
Other facial prosthesis
Earlier craniofacial prostheses were retained with skin pockets, eyeglasses, adhesives, undercuts, and other retentive aids. Percutaneous craniofacial implants have overcome the problems caused due to other methods used to retain prosthesis such as discomfort, skin reactions, poor prosthesis retention, and poor patient acceptance.,,
Curi et al., reported 90.9% and 100% success of implants used to retain nasal, orbital and complex midfacial prosthesis, respectively, in 2 years follow up. Nerad et al., found 100% failure of implants placed to retain orbital prosthesis in irradiated patients followed for 30 months. Granström et al., reported that the orbital implants placed in irradiated bone failed more in number and treatment with hyperbaric oxygen (HBO) helped to reduce the implant failures. In another study done by Granström et al., it was found that 34 implants failed in irradiated bone but when treated with HBO the failure reduced later to only 5 implants.
Successful use of osseointegrated titanium fixtures to retain facial prostheses in cancer patients has been very well proved. Few failures reported with implant-supported orbital prostheses in irradiated cases but that also can be reduced by using HBO.
Limb prostheses and joint prostheses
An inflammatory disease of the joint, rheumatoid arthritis, osteoarthritis, infections, and fracture of the articular surfaces cause destruction of the small joints of the hand. Osseointegration is a valid method of permanent fixation of a wrist joint prosthesis, and the clinicians have come step-by-step closer toward the ultimate prosthesis with lifelong bony fixation, and with the possibility of replacement of the joint mechanism., Hagert et al. had first attempted to establish osseointegration in metacarpophalangeal (MCP) joint arthoplasty in 1986.
Brånemark Osseointegration Centre in Goteborg had introduced the implant-supported prostheses for the rehabilitation of patients with amputated limbs. Osseointegrated implant supported orthopedic prostheses have many advantages like the load was directly transferred to the skeleton, tactile functions were recovered, controlled movement of the prostheses was obtained, and there was no nerve or skin compression as earlier occurred due to socket prostheses.
Lundborg et al.,,, and Hagert et al., found 100% success of joint prostheses retained with osseointegrated titanium implants. No signs of implant loosening were seen and there was radiological and clinical evidence of osseointegration in all cases without any bone resorption. No pain with high level of patient satisfaction and good cosmetic results was obtained with increased range of motion.
Osseointegrated joint implants usually connected with a silicone spacer for joint replacement. Möller et al., found 98% success rate of implants, with 14 implants showed silicone spacer fracture. In another study Möller et al. found the success rate of the implants as 93.18%. Lundborg and Brånemark used interphalangeal joint prostheses with replaceable spacer in their study so that the fractured joint spacers can be replaced easily with a new spacer attached to osseointegrated screws. Lundborg and Brånemark found 100% success of implant survival placed in MCP joints in a 10 years follow-up study.
Worldwide, more than 8,00,000 patients have been treated since 1965 with implant-retained hearing aids, finger joint prosthesis, thumb prostheses, and limb prostheses. A clear superiority over conventional prosthodontics was found in long-term studies.
The term “osseoperception” was defined by Prof. PI Brånemark like an ability of osseointegrated dental implants to transmit a certain amount of sensibility has been documented in numerous publications. Patients restored with implant-supported prostheses reported improved tactile and motor function. The evidence available on the plasticity of the central nervous system (CNS) provides a possible neural basis for our understanding of the accommodation of patients to these changes. Lundborg et al., in their 3 years follow-up study found that the patient rehabilitated with thumb prostheses had achieved some extent of tactile discrimination in the prosthesis. This may be due to the transfer of tactile stimulus to endosteal nerves in the bone via the titanium fixture. In another study, Jacobs et al., found that the patient rehabilitated with implant anchored to bone and supporting prosthesis showed better perception than socket prostheses.
| Conclusion|| |
Brånemark PI considered edentulism as equal to amputation and came up with the concept of osseointegrated implants to overcome them. The innovations of Brånemark had assured the world that it is very much possible to provide implant-supported prosthesis in any situations for the rehabilitation of the individuals. The various articles published by Brånemark had successfully proved his concepts of osseointegration, ad modum, Novum, zygoma implants, implants in compromised sites, implant-supported extraoral and limb prostheses, and osseoperception. His contributions have served to benefit patients who have been treated with implant systems.
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Conflicts of interest
There are no conflicts of interest.
| References|| |
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The bone-anchored auricular episthesis. Laryngoscope 1981;91:811-5.
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Linder L, Albrektsson T, Brånemark PI, Hansson HA, Ivarsson B, Jönsson U, et al.
Electron microscopic analysis of the bone-titanium interface. Acta Orthop Scand 1983;54:45-52.
Tjellström A, Rosenhall U, Lindström J, Hallén O, Albrektsson T, Brånemark PI, et al.
Five-year experience with skin-penetrating bone-anchored implants in the temporal bone. Acta Otolaryngol 1983;95:568-75.
Tjellström A, Yontchev E, Lindström J, Brånemark PI. Five years' experience with bone-anchored auricular prostheses. Otolaryngol Head Neck Surg 1985;93:366-72.
Jackson IT, Tolman DE, Desjardins RP, Brånemark PI. A new method for fixation of external prostheses. Plast Reconstr Surg 1986;77:668-72.
Hagert CG, Brånemark PI, Albrektsson T, Strid KG, Irstam L. Metacarpophalangeal joint replacement with osseointegrated endoprostheses. Scand J Plast Reconstr Surg 1986;20:207-18.
Parel SM, Holt GR, Branemark PI, Tjellstrom A. Osseointegration and facial prosthetics. Int J Oral Maxillofac Implants 1986;1:27-9.
Parel SM, Branemark PI, Tjellstrom A, Gion G. Osseointegration in maxillofacial prosthetics. Part II: Extraoral applications. J Prosthet Dent 1986;55:600-6.
Carlsson L, Röstlund T, Albrektsson B, Albrektsson T, Brånemark PI. Osseointegration of titanium implants. Acta Orthop Scand 1986;57:285-9.
Albrektsson T, Brånemark PI, Jacobsson M, Tjellström A. Present clinical applications of osseointegrated percutaneous implants. Plast Reconstr Surg 1987;79:721-31.
Linder L, Carlsson A, Marsal L, Bjursten LM, Brånemark PI. Clinical aspects of osseointegration in joint replacement. A histological study of titanium implants. J Bone Joint Surg Br 1988;70:550-5.
Smalley WM, Shapiro PA, Hohl TH, Kokich VG, Brånemark PI. Osseointegrated titanium implants for maxillofacial protraction in monkeys. Am J Orthod Dentofacial Orthop 1988;94:285-95.
Nerad JA, Carter KD, LaVelle WE, Fyler A, Brånemark PI. The osseointegration technique for the rehabilitation of the exenterated orbit. Arch Ophthalmol 1991;109:1032-8.
Granström G, Tjellström A, Brånemark PI, Fornander J. Bone-anchored reconstruction of the irradiated head and neck cancer patient. Otolaryngol Head Neck Surg 1993;108:334-43.
Lundborg G, Brånemark PI, Carlsson I. Metacarpophalangeal joint arthroplasty based on the osseointegration concept. J Hand Surg Br 1993;18:693-703.
Rahal MD, Brånemark PI, Osmond DG. Response of bone marrow to titanium implants: Osseointegration and the establishment of a bone marrow-titanium interface in mice. Int J Oral Maxillofac Implants 1993;8:573-9.
Lundborg G, Brånemark PI, Rosén B. Osseointegrated thumb prostheses: A concept for fixation of digit prosthetic devices. J Hand Surg Am 1996;21:216-21.
Lundborg G, Brånemark PI. Anchorage of wrist joint prostheses to bone using the osseointegration principle. J Hand Surg Br 1997;22:84-9.
Brånemark R, Ohrnell LO, Skalak R, Carlsson L, Brånemark PI. Biomechanical characterization of osseointegration: An experimental in vivo
investigation in the beagle dog. J Orthop Res 1998;16:61-9.
Granström G, Tjellström A, Brånemark PI. Osseointegrated implants in irradiated bone: A case-controlled study using adjunctive hyperbaric oxygen therapy. J Oral Maxillofac Surg 1999;57:493-9.
Möller K, Sollerman C, Geijer M, Brånemark PI. Osseointegrated silicone implants 18 patients with 57 MCP joints followed for 2 years. Acta Orthop Scand 1999;70:109-15.
Möller K, Sollerman C, Geijer M, Brånemark PI. Early results with osseointegrated proximal interphalangeal joint prostheses. J Hand Surg Am 1999;24:267-74.
Jacobs R, Brånemark R, Olmarker K, Rydevik B, Van Steenberghe D, Brånemark PI, et al.
Evaluation of the psychophysical detection threshold level for vibrotactile and pressure stimulation of prosthetic limbs using bone anchorage or soft tissue support. Prosthet Orthot Int 2000;24:133-42.
Rahal MD, Delorme D, Brånemark PI, Osmond DG. Myelointegration of titanium implants: B lymphopoiesis and hemopoietic cell proliferation in mouse bone marrow exposed to titanium implants. Int J Oral Maxillofac Implants 2000;15:175-84.
Lundborg G, Brånemark PI. Osseointegrated proximal interphalangeal joint prostheses with a replaceable flexible joint spacer – Long-term results. Scand J Plast Reconstr Surg Hand Surg 2000;34:345-53.
Holgers KM, Brånemark PI. Immunohistochemical study of clinical skin-penetrating titanium implants for orthopaedic prostheses compared with implants in the craniofacial area. Scand J Plast Reconstr Surg Hand Surg 2001;35:141-8.
Lundborg G, Brånemark PI. Osseointegrated silicone implants for joint reconstruction after septic arthritis of the metacarpophalangeal joint: A 10-year follow-up. Scand J Plast Reconstr Surg Hand Surg 2001;35:311-5.
Brånemark R, Brånemark PI, Rydevik B, Myers RR. Osseointegration in skeletal reconstruction and rehabilitation: A review. J Rehabil Res Dev 2001;38:175-81.
Lundborg G, Besjakov J, Brånemark PI. Osseointegrated wrist-joint prostheses: A 15-year follow-up with focus on bony fixation. Scand J Plast Reconstr Surg Hand Surg 2007;41:130-7.
Curi MM, Oliveira MF, Molina G, Cardoso CL, Oliveira Lde G, Branemark PI, et al.
Extraoral implants in the rehabilitation of craniofacial defects: Implant and prosthesis survival rates and peri-implant soft tissue evaluation. J Oral Maxillofac Surg 2012;70:1551-7.
Meirelles L, Brånemark PI, Albrektsson T, Feng C, Johansson C. Histological evaluation of bone formation adjacent to dental implants with a novel apical chamber design: Preliminary data in the rabbit model. Clin Implant Dent Relat Res 2015;17:453-60.
Dr. Ramesh Chowdhary
Department of Prosthodontics, Rajarajeswari Dental College and Hospital, Bengaluru - 560 074, Karnataka
Source of Support: None, Conflict of Interest: None
[Table 1], [Table 2]