Studies have proven the concept of osseointegration to be highly successful. 1–4 However, to achieve this predictable success rate, a strict protocol had to be followed. 5 Researchers have challenged several aspects of this rigorous protocol. Their investigations have found the relative importance of each variable in respect to its influence on osseointegration; incision designs, 6 sterile protocol, 7 two-stage surgery, 8 and early loading 9 are but a few examples.
For a long time, the timing of loading has been rigidly controlled in clinical investigations. An implant is considered to be immediately loaded if full occlusal load, ie, presence of evident occlusal contact when checked with a thin occlusal paper, is placed on the implant through a prosthesis, fixed or removable, provisional or permanent, within 72 hours after placement. Only a few clinicians ventured to immediately load root-form implants in limited clinical situations. The reason lies in the critical association between achieving osseointegration and the absence of loading. After all, immediate loading in the early works on dental implants resulted in fibrous encapsulation. 10 Some clinicians immediately loaded implants for the purpose of provisionalization, and the results were surprisingly positive. Starting with a few implants immediately loaded with a bar-overdenture in the mandible, 11,12 the concept evolved to loading multiple implants with a fixed prosthesis in the mandible 13–16 and in the maxilla. 13,16
Today, research has established the principles of immediate loading and the parameters for its success. 16 These principles are based on a differentiation between “loading” and “minimizing micro-movement.” Loading reflects the weight or stress placed on the implant and transmitted to the bone. In experimental studies, immediate loading of three implants, single standing 17 or splinted, 18 resulted in osseointegration. Retrieved immediately loaded implants after 8 to 9 months of service from a human mandible also showed bone-to-implant contact. 19 Micromotion is a subclinical level of movement of the implant relative to the bone. The degree of micromotion, which is deleterious to osseointegration is difficult to quantify or measure. Several researchers have studied bone healing around implants subjected to different magnitudes of load. These articles put the tolerated threshold of micromotion at about 100 microns. 20–23 This led researchers to state “…it appears that premature loading per se does not lead to fibrous tissue encapsulation,”24 or “…it is not the absence of loading per se that is critical for osseointegration around implants, but rather the absence of micromotion at the interface.”25 In the above context, osseointegration is best understood as “undisturbed bone healing around the implant.”25
The purpose of this prospective study is to determine if with adequate case selection and adherence to established principles, immediate loading of Osseotite implants (3i, Implant Innovations, Inc.) could be considered for routine clinical use. The Osseotite implant has a uniquely bioengineered surface created by an acid-etching process using hydrochloric and sulfuric acid applied to a commercially pure titanium implant. The Osseotite implant is a hybrid implant with the first three threads having a machined surface, and the rest of the implant having the Osseotite surface.
Materials and Methods
Patients requiring full arch implant rehabilitation were considered for this prospective study. To be included in the study, the following criteria were required: full arch rehabilitation allowing for cross-arch stabilization, a minimum of six implants to be placed, and the minimum length of each implant to be 10 mm. All patients were informed of the procedure and signed a consent form. Two different protocols were followed. The first protocol consisted of immediately loading the implants with a fixed provisional prosthesis (Group A), and the second consisted of loading the implants 48 hours after placement with the final porcelain-fused-to-metal prosthesis (Group B). Clinical examination based on aesthetic and functional criteria determined the suitable protocol for each patient. A provisional prosthesis was used if esthetics was considered to be critical. This allowed for tissue remodeling or for soft tissue surgery to be performed at later stages before the construction of the final prosthesis. Also, a provisional prosthesis permitted the testing of the occlusion and was selected if occlusal treatment was required.
All the patients took a systemic antibiotic 1 hour before surgery (2 g Amoxicillin). Group A took another dose 6 and 12 hours after surgery (1 g Amoxicillin). Group B took another dose 6 hours after surgery (1 g Amoxicillin) and was placed on an 8-hour regimen for the following 4 or 5 days (0.5 g Amoxicillin). All surgeries were performed under sterile technique. A crestal incision was made to access the alveolar crest. Implant sites were prepared following standard protocol, ie, using low-speed drilling and irrigation with sterile saline. During implant insertion in the bony site, no irrigation with sterile saline was used. The flaps were coronally repositioned and closed with horizontal mattress sutures. After surgery, the patients were instructed to rinse with chlorhexidine twice a day for 15 days and then use an extra-soft toothbrush for another 15 days.
After the insertion of the implants, two different prosthetic protocols were followed.
1. Immediate loading with fixed provisional prostheses (Group A).
After removal of the implant mounts, PrepTite (3i, Implant Innovations, Inc.) abutments with 4 mm collars were inserted in the maxillary cases. In the mandibular cases, standard abutments were placed on the implants, and then castable plastic sleeves (SGC34; 3i, Implant Innovations, Inc.) were placed on the abutments. These restorations were screw-retained. In the maxilla, the provisional prostheses, which were fabricated on the study models, were hollowed, connected to the abutments (PrepTite) with cold-cured resin, trimmed, and polished. In the mandible, the provisional prosthesis was connected to the plastic sleeves with cold-cured resin, trimmed, and polished (Case 1: A mandibular case of a 64-year-old patient, Figs. 1–7). The final screw-retained prostheses in the mandible were inserted 6 months after surgery. Final impressions for the maxillary cases were made 1 year after surgery, and the final cement-retained, porcelain-fused-to-metal prostheses were inserted shortly thereafter. The occlusion was designed with bilateral contacts in centric and canine guidance in all excursive movements.
2. Immediate loading with fixed porcelain-fused-to-metal prostheses (Group B).
At the time of surgery, after removal of the implant mounts, impression copings were connected and impressions were made. Two-piece healing abutments, 6 mm in height (TH256), were placed and the flaps were sutured. After 48 hours without any prosthesis, the final porcelain-fused-to-metal, screw-retained implant supported prostheses were inserted, and the appropriate torque applied to the screws, ie, 20 N/cm for the standard abutment titanium screw used in mandibular cases and 32 N/cm for the UCLA abutment square screw Gold-Tite (3i, Implant Innovations, Inc.) used in the maxilla. The occlusion was designed with bilateral contacts in centric and canine guidance in all excursive movements (Case 2: A mandibular case of a 72-year-old patient, Figs. 8–15; and Case 3: Maxillary case of a 57-year-old patient, Figs. 16–20).
Postoperative follow-up took place at the first, second, and fourth weeks. Thereafter, control visits were scheduled at the 3rd, 6th, 12th, 18th, 24th, and 30th months. The screw-retained prostheses were removed after the 6th, 12th, 18th, 24th, and 30th month after surgery to check the mobility of every implant. Radiographic films were also taken at the 12th and 24th months for bone level evaluation.
Radiographic Evaluation of Bone Level
A Hawe Neos Super-Bite (Hawe Neos Dental, Bioggio, Switzerland) device was used to position the films parallel to the implants. All the periapical radiographs were digitized at 600 ppi. The images were magnified 10 times. A ratio or normalizing factor of the measured/actual length of each patient-implant was determined by dividing the observed reference value by the actual value. The length of the implant was used to calculate the normalizing factor for each image. If the entire length of the implant was not observed on the image, the abutment was used to calculate the normalizing factor. The bone level was measured from the implant platform, ie, implant/abutment junction to the first radiographic bone-to-implant contact. A mesial and a distal reading were obtained for each implant at the 12th and 24th month. Applying the corresponding normalizing factor normalized the values obtained. The criteria for success published by Albrektsson et al 26 were followed to evaluate every implant.
Eleven patients were consecutively enrolled, five women and six men; they received 87 Osseotite implants. Five mandibular cases were treated with six implants each. Eighteen of these implants were placed in type I bone (≈21%), and 12 in type II bone (≈14%). Six maxillary cases were treated: one case received eight implants, another received nine implants, and four cases received 10 implants each. The bone quality in the maxilla was type III for 46 implants (≈52%), and type IV for 11 implants (≈13%). The distribution by implant length and diameter is shown in Tables 1 and 2. Extended platform implants were used to achieve a better prosthetic support in molar areas where the bone volume was limited. Also, extended platform implants (4/5) were used in certain central incisor positions to achieve a better emergence profile.
Four cases were loaded with provisional prostheses: two in the mandible and two in the maxilla. Seven cases were loaded with fixed porcelain-fused-to-metal prostheses: three in the mandible and four in the maxilla. In six cases, the opposing dentition consisted of natural teeth and fixed prostheses. In four cases, the opposing dentition was a removable prosthesis. In one case, the opposing dentition was implant supported.
Postoperative healing was uneventful in all cases. Two-year follow-up was performed for all the cases and nine cases (67 implants) were followed for 30 months. At the 2-year examination, all the implants were successful clinically and radiographically. The average radiographic bone level was 0.654 mm at the 12th month and 0.946 mm at the 24th month (Table 3). There were no implant mobilities or periimplant radiolucencies observed at the recall appointments. The 30-month follow-up of nine cases with 67 implants resulted also in 100% success rate.
Immediate loading of implants within 72 hours finds its application in certain clinical situations where cross-arch stabilization is feasible and bone volume is adequate for the placement of a 10 mm implant. Once the above mentioned success parameters had been defined, immediately loaded implants proved to be at least as successful as implants placed under a standard protocol. 27,28 Controlling micromotion is the key issue to obtain osseointegration of the immediately loaded implants. Reducing micromotion is achieved through a wide anterior-posterior distribution of the immediately loaded implants and cross-arch stabilization of the edentulous arches with a rigid prosthesis. Stability of the individual implant is also important. To increase the implant stability, the minimum implant length should be 10 mm. 16
In the edentulous mandible, Tarnow et al 16 immediately loaded 35 implants (20 machined surface and 15 textured surface) in six patients; two machined-surfaced implants failed yielding a success rate of 94.3%. Horiuchi et al 29 immediately loaded 96 machined-surfaced implants in 12 patients in the mandible; two implants failed yielding a success rate of 97.9%. In the edentulous maxilla, Tarnow et al 16 immediately loaded 34 implants (14 machined surface and 20 textured surface) in four patients and reported a 100% success rate. Horiuchi et al 29 immediately loaded 44 machined-surfaced implants in five patients in the maxilla; two implants failed yielding a success rate of 95.5%. In these two studies, the decision to immediately load an implant depended on its initial stability at placement, which was assessed by the Periotest value 16 or the torque value. 29 The successful integration of the immediately loaded implants in the initial cases encouraged the authors 16 to immediately load an increasing number of implants. Consequently, the recent trend in the literature is to load all implants with primary stability, which led to the decision in the present study to immediately load all the implants that had primary stability at placement.
The increasing number of successful maxillary cases may signify that bone quality may not be as critical as it was thought 30 to be, especially if an enhanced textured implant surface is used, like an acid-etched, plasma sprayed or coated surface. This assumption is supported by the previously discussed clinical trials. In one additional report, in a series of 27 cases, four maxillary and 23 mandibular, partially and fully edentulous arches were immediately loaded. 31 In the mandible, 122 implants were immediately loaded; 95 of these had a textured surface and 27 had a machined surface. One of the 95 textured implants failed, and seven of the 27 machined implants failed. All 27 textured implants immediately loaded in the maxilla integrated. Excluding a cluster failure of 4 machined-surfaced implants in one patient, the authors reported a success rate of 99% for the textured-surfaced implants and 83% for the machined-surfaced implants.
The 100% success achieved in the present study can also be explained by the characteristics of the implant surface. Osseotite is a uniquely bioengineered surface created by an acid-etching process using hydrochloric and sulfuric acid applied to a commercially pure titanium implant. The textured Osseotite surface prevents the contraction of the fibrin clot away from the implant surface rendering the Osseotite surface to be osteoconductive. Because the fibrin clot is retained by the osteoconductive implant surface, the osteogenic cells form bone directly on the implant surface by a process called “contact osteogenesis,” resulting in an accelerated early bone healing. 32 This concept is behind the clinical modification of the traditional surgical protocol that required irrigation of the implant during insertion. Because retention of the fibrin clot on the Osseotite surface is important, irrigating the implant with saline solution washes away the blood coming out of the bony site and prevents it from creeping along the implant surface during placement. Furthermore, when compared with the machined surface, the Osseotite surface exhibited a statistically significantly higher percentage of bone-to-implant contact in poor quality bone, 33 as well as a higher cumulative success rate in clinical study. 34
The effect of immediate loading on the bone-to-implant interface was investigated in monkeys. 35 The histomorphometric results showed an overall statistically significant greater bone-to-implant contact in the immediately loaded implants versus control, 70.2% ± 7.3 and 55.1% ± 5.1, respectively. Both maxillary and mandibular immediately loaded implants had statistically greater bone-to-implant contact, 67.3% ± 7.6 and 73.2% ± 5.9, respectively, when compared with control implants placed in the maxilla and the mandible, 54.5% ± 3.3 and 55.8% ± 6.5, respectively. In humans, two immediately loaded implants were retrieved after 4 months of loading. 36 Immediate loading did not impede osteogenesis and bone remodeling on the Osseotite surface and histomorphometric evaluation revealed a high level of bone-to-implant contact, ranging from 78% to 85%.
In conclusion, there exists substantial clinical and histological research that supports the concept of immediate loading. Critical analysis of the literature favors the usage of textured-surface implants to achieve a higher success rate. Under the previously discussed conditions, ie, long implants, 10 mm or longer, and cross-arch stabilization, a high success rate can be achieved when Osseotite implants are immediately loaded in the maxilla and the mandible. Further research is needed to understand the effects of immediate loading on the early bone healing around the acid-etched implants.
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Abstract Translations [German, Spanish, Portuguese, Japanese]
AUTOR(EN): Juan Carlos Ibañez, Od, DD*, Ziad N. Jalbout, DDS**. *Ehemaliger Professor für Okklusion an der Universität von Cordoba, Cordoba, Argentinien; Leiter des Postgraduierten-Froschungsprogrammes für knochenintegrierte Implantate, Cordoba, Agentinien; privat praktizierender Arzt, Cordoba, Argentinien. **Hochschulabsolvent, Ashman – Abteilung für Zahnimplantatkunde, Universität von New York, Fachbereich Zahnmedizin, New York, New York. Schriftverkehr: Juan Carlos Ibañez, Od, DD, Obispo Oro 414 Cordoba (5000) Republica Argentina. Telefon./Fax: 54 – 351 – 4680156. eMail: email@example.com. Rückfragen den Artikel betreffend an:Ziad N. Jalbout, DDS, 206 E 10th St. #4A, New York, NY 10003-7737 USA. Telefon: 212 – 505 – 7891, Fax: 212 – 995 – 4337. eMail: firstname.lastname@example.org
ZUSSAMENFASSUNG: Das Leben vieler Patienten wurde durch den großen Behandlungserfolg bei Zahnimplantierungen wesentlich positiv beeinflusst. Die sofortige Belastung der Implantate als Spezialfall bringt zusätzlich in der Patientenbehandlung zu berücksichtigende Besonderheiten mit sich. Was im kleinen Rahmen mit der Implantierung einiger Zahnimplantate in den Unterkiefer und deren sofortiger Belastung mittels einer Deckprothese bereits 72 Stunden nach dem Eingriff begann, entwickelte sich zu einem multiplen Implantierungskonzept in sowohl Unter- als auch Oberkiefer. Bei der hier zugrunde liegenden Studie wurde zwischen Juni 1998 und Juni 1999 bei 11 aufeinanderfolgenden Patienten eine Behandlung mit 87 schraubenförmigen, säuregeätzten Osseotite® Endostalimplantaten (3i, Implant Innovations, Inc., Palm Beach Gardens, FL.) durchgeführt. Bei jeweils zwei Fällen der Implantierung im Ober- und im Unterkiefer wurden bereits am Operationstag schraubenfixierte vorläufige Prothesen eingesetzt. Bei drei Implantateinsätzen im Unterkiefer und vier Implantierungen im Oberkiefer erfolgte die Belastung mit der endgültigen schraubenfixierten Porzellan-Metall-Prothese bereits 48 Stunden nach dem Eingriff. Alle diese Implantate unterlagen in den nächsten zwei bis drei Jahren regelmäßigen Folgeuntersuchungen auf der Basis von sowohl klinischen als auch röntgenographischen Tests. Alle Implantate blieben intakt, sie saßen fest, und es war auch keinerlei Röntgenstrahldurchlässigkeit in der Implantatsumgebung feststellbar. Jeweils nach 12 und nach 24 Monaten erfolgte eine Messung des Knochenbildungsgrades. Hierbei lag der durchschnittliche Grad der röntgenographisch ermittelten Knochenbildung von Implantatsboden bis zum ersten Knochen-Implantatskontakt nach dem Ablauf der 12 Monate bei 0,654 mm und nach 24 Monaten bei 0,946 mm. Die Untersuchungen lassen den Rückschluss zu, dass durch die unmittelbar innerhalb von 48 Stunden nach dem chirurgischen Eingriff erfolgende Belastung von Implantaten mit hybrider Oberfläche und maschineller Formung bzw. Säureätzung im Ober- und Unterkiefer ein erstklassiger Behandlungserfolg erzielt werden kann.
SCHLÜSSELWÖRTER: Zahnimplantate, unmittelbare Belastung, säuregeätzte Oberfläche, vollkommen zahnlos, Behandlungserfolg
AUTOR(ES): Juan Carlos Ibañez, Od, DD.*, Ziad N. Jalbout, DDS.**. *Ex Profesor de Oclusión en la Universidad de Córdoba, Cordoba, Argentina. Director del Programa PostGraduado de Implantes Oseointegrados, Cordoba, Argentina. Práctica privada, Córdoba, Argentina. **Graduado, Departamento de Odontología de Implantes Ashman, Facultad de Odontología de New York University, Nueva York, Nueva York.Correspondencia a: Juan Carlos Ibañez, Od. DD, Obispo Oro 414, Córdoba 5000 Republica Argentina. Teléfono/fax: 54-351-4680156. Correo electrónico: email@example.com. Por favor, enviar toda la correspondencia sobre la publicación y presentación del artículo a: Ziad N. Jalbout, DDS., 206 E 10th St., #4A, New York, New York 10003-7737 U.S.A. Teléfono: 212-505-7891, Fax: 212-995-4337 Correo electrónico: firstname.lastname@example.org.
ABSTRACTO: El alto éxito de los implantes dentales ha cambiado la calidad de vida de muchos pacientes. La carga inmediata encuentra su aplicación en algunos casos clínicos y ciertamente agrega otra modalidad de tratamiento para el paciente con un implante. Comenzar con un par de implantes colocados en la mandíbula e inmediatamente cargados dentro de 72 horas después de la colocación quirúrgica con una sobredentadura, este concepto evolucionó hasta cargar inmediatamente varios implantes en la maxila y la mandíbula. En esta investigación, se trató a 11 pacientes consecutivos con 87 implantes Osseotite® grabados con ácido endostales con forma de tornillos (3i, Implant Innovations, Inc., Palm Beach Gardens, FL) entre junio de 1998 y junio de 1999. Dos casos mandibulares y dos casos maxilares recibieron prótesis provisionales retenidas con tornillos el día de la operación. Tres casos mandibulares y cuatro maxilares fueron cargados cuarenta y ocho horas después de la cirugía con la prótesis final de porcelana unida a metal retenida con tornillos. Todos los implantes fueron seguidos durante dos a tres años. El seguimiento consistió de exámenes clínicos así como radiográficos. Todos los implantes fueron exitosos. No se encontró movilidad del implante ni radioluminiscencia periimplante. El nivel del hueso se midió a los 12 y 24 meses. El nivel promedio de hueso radiográfico de la plataforma del implante hasta el primer contacto del hueso con el implante a lo 12 meses fue de 0,654 mm y a los 24 meses, 0,946 mm. Concluimos que se puede lograr un alto grado de éxito cuando los implantes con una superficie híbrida, grabado con ácido o a máquina, son cargados inmediatamente dentro de las 48 horas después de la colocación quirúrgica en la maxila y la mandíbula.
PALABRAS CLAVES: implantes dentales, carga inmediata, superficie grabada con ácido, totalmente edentulosa, tasa de éxito.
AUTOR(ES): Juan Carlos Ibañez, Od, DD.*, Ziad N. Jalbout, DDS.**. *Ex-professor de Oclusão na Universidade de Córdoba, Córdoba, Argentina, Diretor do Programa de Pós-graduação em Implantes Osseointegrados em Córdoba, Argentina. Clínica particular, Córdoba, Argentina. **Graduado do Departamento Ashman de Odontologia de Implantes, Faculdade de Odontologia da Universidade de Nova York, Nova York, Nova York. Correspondências devem ser enviadas a:Juan Carlos Ibañez, Od, DD., Obispo Oro 414 Córdoba (5000) República Argentina. Telefone/Fax: 54-351-4680156 e-mail: email@example.com. Envie toda a correspondência relacionada à publicação e ao envio deste artigo para:Ziad N. Jalbout, DDS., 206 E 10th St. no 4A, Nova York, Nova York 10003-7737 EUA. Telefone: (212)505-789, Fax: (212)995-433. e-mail: firstname.lastname@example.org
SINOPSE: a alta taxa de sucesso dos implantes odontológicos melhorou a qualidade de vida de vários pacientes. Alguns casos clínicos se predispõem à aplicação imediata, o que certamente proporciona mais uma modalidade de tratamento ao paciente de implante. Ao se iniciar com dois implantes posicionados na mandíbula e ao se carregar imediatamente, dentro de 72 horas após a colocação, por cirurgia, uma sobredentadura, este conceito evoluiu para a colocação imediata de implantes múltiplos tanto na maxila quanto na mandíbula. Nesta pesquisa, 11 pacientes foram tratados de forma consecutiva com 87 implantes Osseotite® endosteal, em forma de parafuso, tratados por corrosão ácida (3i, Implant Innovations, Inc., Palm Beach Gardens, FL.) entre junho de1998 e junho de 1999. Dois casos de mandíbulas e dois casos de maxilas receberam próteses provisórias presas por parafuso no dia da cirurgia. Três casos de mandíbulas e quatro casos de maxilas foram colocados quarenta e oito horas após a cirurgia com as próteses finais presas por parafuso de porcelana fundida com metal. Todos os implantes foram acompanhados por dois ou três anos. O acompanhamento consistiu em exames clínicos e radiográficos. Todos os implantes tiveram sucesso. Não foi verificada nenhuma mobilidade dos implantes e tampouco radiopacidade ao redor do implante. O nível ósseo foi medido no 12o e no 24o mês. O nível ósseo radiográfico médio da plataforma de implante até o primeiro contato do osso com o implante no 12o mês foi de 0,654 mm e de 0,946 mm no 24o mês. Concluímos que uma alta taxa de sucesso pode ser atingida quando implantes com uma superfície híbrida, tratada por corrosão ácida/fresada, são colocados imediatamente dentro de 48 horas após o posicionamento cirúrgico na maxila e na mandíbula.
PALAVRAS-CHAVES: implantes odontológicos, colocação imediata, superfície tratada por corrosão ácida, completamente edêntulo, taxa de sucesso.