10 Years of XiVE Implantology Unlimited

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2 10 Years of XiVE Implantology Unlimited Implantology Unlimited is obligate for XiVE and every limit gives always a push to surrender new challenges: Primary stability in low bone quality? No problem with XiVE s condensing thread design. Implant solution for the narrowest gaps? XiVE S 3.0 mm is the missing link! High-quality temporary denture in only five minutes? The XiVE TempBase makes it possible. Prosthetics without compromise? Various solutions set standards! Transform your limitations into expanded horizons. With XiVE. Get the Xperience!

3 10 Years of XiVE Implantology Unlimited Implantology Unlimited is obligate for XiVE and every limit gives always a push to surrender new challenges: Primary stability in low bone quality? No problem with XiVE s condensing thread design. Implant solution for the narrowest gaps? XiVE S 3.0 mm is the missing link! High-quality temporary denture in only five minutes? The XiVE TempBase makes it possible. Prosthetics without compromise? Various solutions set standards! Transform your limitations into expanded horizons. With XiVE. Get the Xperience!

4 XiVE 10 Years of Progress 10 years of XiVE that s 10 years of progress and innovative solutions. 10 years of XiVE that s 10 years of surgical versatility and almost unlimited prosthetic freedom. 10 years of XiVE that s only the beginning : Introduction of the XiVE S (S = subgingival) implants, incl. the TempBase concept and EsthetiCap 2002: Introduction of the XiVE TG (TG= transgingival) implants 2003: Introduction of the XiVE S 3.0 mm implants and the FRIADENT plus surface 2004: Over 100,000 implants sold across Germany over 300,000 XiVE sold worldwide 2005: Introduction of the CERCON zirconium dioxide abutment for superior esthetics 2006: Survey by an independent market research institute shows that 92% of XiVE s users are highly satisfied with the implant system

5 2007: Introduction of the modular surgical kit 2008: Introduction of No Touch packaging, incl. the implant shuttle (awarded the reddot design award 2008) 2009: Introduction of XiVE Guided Surgery with ExpertEase TM, XiVE CAD/CAM bridges and bars and XiVE Custom Abutments by Compartis 2010: Introduction of the laterally accessible ExpertEase TM sleeves, more than 1.7 million XiVE implants sold worldwide 2011: Introduction of XiVE TitaniumBase and ScanBase, the XiVE surgical ratchet with torque indicator, the XiVE ExpertEase TM laboratory components for temporary dentures fabricated in the dental lab prior to implant placement

6 XiVE 10 Years of Success 99.3% Success rate using XiVE

7 Success rates using XiVE Author Published Number of XiVE implants Losses XiVE success rate % Observation period (months) Implant sites Degidi, M et al. [1] , Maxilla, Mandible Payer, M et al. [2] Mandible posterior Degidi, M et al. [3] Lateral Maxilla, Incisivi Di Stefano, DA et al. [4] Mandible Redemagni, M et al. [5] n.a. Maxilla, regio Payer, M et al. [6] Mandible posterior Merli, M et al. [7] n.a. Degidi, M et al. [8] , Maxilla, Mandible Enislidis, G et al. [9] Mandible Degidi, M et al. [10] Maxilla, Mandible Result: 6, % The implants treated in the publications included all diameters and lengths, all indications, all loading options and all bone qualities. The clinical data substantiate the clinical success and the comprehensive experience with XiVE. Literature: 1. Degidi, M, Daprile, G and Piattelli, A: Primary stability determination by means of insertion torque and RFA in a sample of 4,135 implants. Clin Implant Dent Relat Res; 2010, 2. Payer, M, Heschl, A, Wimmer, G, et al.: Immediate provisional restoration of screw-type implants in the posterior mandible: results after 5 years of clinical function. Clin Oral Implants Res; 2010, 21 (8): Degidi, M, Nardi, D and Piattelli, A: Immediate versus one-stage restoration of small-diameter implants for a single missing maxillary lateral incisor: a 3-year randomized clinical trial. Journal of periodontology; 2009, 80 (9): Di Stefano, DA, Artese, L, Iezzi, G, et al.: Alveolar ridge regeneration with equine spongy bone: a clinical, histological, and immunohistochemical case series. Clin Implant Dent Relat Res; 2009, 11 (2): Redemagni, M, Cremonesi, S, Garlini, G and Maiorana, C: Soft tissue stability with immediate implants and concave abutments. Eur J Esthet Dent; 2009, 4 (4): Payer, M, Kirmeier, R, Jakse, N, et al.: Immediate provisional restoration of XiVE screw-type implants in the posterior mandible. Clin Oral Implants Res; 2008, 19 (2): Merli, M, Migani, M and Esposito, M: Vertical ridge augmentation with autogenous bone grafts: resorbable barriers supported by ostheosynthesis plates versus titanium-reinforced barriers. A preliminary report of a blinded, randomized controlled clinical trial. Int J Oral Maxillofac Implants; 2007, 22 (3): Degidi, M, Piattelli, A and Carinci, F: Parallel screw cylinder implants: comparative analysis between immediate loading and two-stage healing of 1005 dental implants with a 2-year follow up. Clin Implant Dent Relat Res; 2006, 8 (3): Enislidis, G, Wittwer, G and Ewers, R: Preliminary report on a staged ridge splitting technique for implant placement in the mandible: a technical note. Int J Oral Maxillofac Implants; 2006, 21 (3): Degidi, M and Piattelli, A: Comparative analysis study of 702 dental implants subjected to immediate functional loading and immediate nonfunctional loading to traditional healing periods with a follow-up of up to 24 months. Int J Oral Maxillofac Implants; 2005, 20 (1):

8 Four thousand one Study of more than 4,000 XiVE Implants by Degidi et al. in 2011 Confirms High Success Rates, even in Immediate Implant Placement A current clinical investigation of 4,135 XiVE implants by Degidi, Daprile and Piattelli shows that the measurement of the insertion torque and the resonating frequency analysis (RFA) describe different parameters of the primary stability of implants. According to this study, there is a direct association between bone thickness and insertion torque, while the RFA results bear more relation to the implant lengths used. A comparably high primary stability was able to be achieved with XiVE implants in all bone qualities, both in delayed and in immediate implant placements. In addition, no increase in the loss rate was identified for the immediate implant placements in comparison with the delayed implant placements. In general, the early losses documented as a part of the investigation were extremely slight, such that the success rate after six months was 99.3 percent. The authors concluded from this that, subject to the instructions for use and with accurate patient selection, XiVE is very dependable, both in the healed bone and when used directly following the dental extraction. In their most recent publication, the Italian research, group headed by Doctor Marco Degidi and Professor Adriano Piattelli, comes to the conclusion that the primary stability can in fact be verified using both techniques, although the measurements represent different characteristics of the primary stability. The implant stability quotient (ISQ), obtained from the RFA, reflects the resistance to vertical flexural loads, while the insertion torque measured provides information on the resistance to shearing forces acting parallel to the implant body. In a large-scale investigation with 4,135 XiVE implants (DENTSPLY Friadent Mannheim, Germany) used for over a thousand patients between 2002 and 2009, Degidi, Piattelli and Daprile were able to show that there is, in fact, an association between primary stability and insertion torque values or primary stability and the ISQ, although a direct correlation between the two measuring techniques themselves is not probable. Patients who required one or more implants were selected for the investigation. Depending on the clinical situation,

9 hundred thirty-five immediate implant placements or delayed implant placements were performed. In the course of this, the manufacturer s prescribed drilling sequence was observed. The patients were given antibiotic cover and received postsurgical analgesic treatment. The sutures were removed two weeks after the surgical procedure. The bone thickness was radiologically determined for each implant. Additionally, the length and diameter of the implants, the maximum insertion torque and the RFA values (Osstell Mentor, Osstell Goeteborg AB, Sweden) were documented on insertion. The evaluation of the data showed that the greatest number of the implants were placed in D2 and D3 quality bones (32 and 46.5 percent, respectively), although 9 percent was still placed in D1 and 12.5 percent in D4. All available XiVE implant lengths and diameters were used. The majority of the teeth to be replaced were located in the posterior regions of the jaw. Overall, 3,249 implants (1,486 in the maxilla and 1,763 in the mandible) were inserted here. In contrast, 606 implants were inserted in the anterior maxilla, and 280 in the mandible. Additionally, the researchers recorded implant losses occurring within the first six months after insertion. The data show that there is a direct association between bone thickness and insertion torque, although not between bone thickness and resonating frequency analysis. The latter, in turn, is affected by the implant length used. These new results do not coincide with the results of earlier publications, which, according to the authors, can be traced back to the small number of implants investigated in the older studies on the one hand and, on the other, to the classic Brånemark implant design used [1-4]. In the studies cited by Degidi and his colleagues in this connection, a modified protocol had been suggested in order to be able to achieve a higher primary stability using the Brånemark implant. This is necessary, particularly in respect of accelerated forms of treatment such as immediate implant placement and immediate restoration. continuing >

10 XiVE 4,135 Implants, Success Rate 99.3% Within the scope of this investigation, Degidi, Daprile and Piattelli were able to establish a success rate of 99.3 percent for the XiVE implants inserted and were able to achieve an adequate primary stability in all bone qualities. It is striking that no increased loss rate was noted, even for immediate implant placement. The authors conclude from this that, subject to the instructions for use and with accurate patient selection, the use of XiVE implants with the specific thread design is very dependable, both in healed bone and when used directly following a dental extraction, and that a good primary stability can be obtained using the standard protocol. Note on the measuring techniques used: Measurement of the insertion torque and the RFA proved particularly reliable for the evaluation of the primary stability. While a calibrated measuring instrument that, e.g. is integrated into the surgical unit, is used to measure the insertion torque, for the RFA, the decrease in resonance in a vibratory system is measured. Original publication: Primary Stability Determination by Means of Insertion Torque and RFA in a Sample of 4,135 Implants Marco Degidi, Giuseppe Daprile, Adriano Piattelli Clinical Implant Dentistry and Related Research, Marco Degidi, MD, DDS Bologna/Italy Medical School/University of Bologna/Italy Diplomate Misch Implant Institutes, Detroit/USA Currently member of several international associations International lecturer and author of numerous scientific publications Private Practice in Bologna restricted to implant surgery and prosthetics Winner of the FRIADENT Implant Dentistry Award 2001 (1 st prize)

11 Distribution and Mean Peak IT and RFA of the Implants by Bone Quality Bone Quality Number of Implants MeanPeak IT Mean RFA D1 D2 2, ± ± D3 D4 2, ± ± Distribution and Mean Peak IT and RFA of the Implants by Length Implant Length Number of Implants Mean Peak IT Mean RFA Distribution and Mean Peak IT and RFA of the Implants by Diameter Implant Diameter , , Number of Implants 417 1,406 1, IT = insertion torque; RFA = resonating frequency analysis ± ± ± ± ± ± Mean Peak IT ± ± ± ± ± ± ± ± ± ± ± 9.67 Mean RFA ± ± ± ± ± Literature: 1. Ostman PO: Immediate/early loading of dental implants. Clinical documentation and presentation of a treatment concept. Periodontol 2000; 2008; Ostman PO, Hellman M, Wendelhag I, Sennerby L: Resonance frequency analysis measurements of implants at placement surgery. Int J Prosthodont; 2006; 19 (1): 77-83; discussion Turkyilmaz I: A comparison between insertion torque and resonance frequency in the assessment of torque capacity and primary stability of Branemark system implants. J Oral Rehabil; 2006; 33 (10): Turkyilmaz I, Tozum TF, Tumer C, Ozbek EN: Assessment of correlation between computerized tomography values of the bone, and maximum torque and resonance frequency values at dental implant placement. J Oral Rehabil; 2006; 33 (12):

12 Order No /002 Friadent GmbH P. O. Box Mannheim/Germany Phone Fax for FRIADENT Class I Devices for FRIADENT Class II a, II b and III Devices 0911/4.0/SB

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