An open prospective single cohort multicenter study evaluating the novel, tapered, conical connection implants supporting single crowns in the anterior and premolar maxilla: interim 1-year results

Alexander Fügl, Werner Zechner, Alessandro Pozzi, Guido Heydecke, Christine Mirzakhanian, Nikolaus Behneke, Alexandra Behneke, Russell A Baer, Robert Nölken, Edward Gottesman, Snjezana Colic, Alexander Fügl, Werner Zechner, Alessandro Pozzi, Guido Heydecke, Christine Mirzakhanian, Nikolaus Behneke, Alexandra Behneke, Russell A Baer, Robert Nölken, Edward Gottesman, Snjezana Colic

Abstract

Objectives: The aim of this multicenter prospective clinical study was to evaluate anodized tapered implants with a conical connection and integrated platform shifting placed in the anterior and premolar maxilla.

Materials and methods: The study enrolled patients requiring single-tooth restorations in healed sites of maxillary anterior and premolar teeth. All implants were immediately temporized. Clinical and radiographic evaluations were conducted at implant insertion, 6 months, and 1 year. Outcome measures included bone remodeling, cumulative survival rate (CSR), success rate, soft-tissue health and esthetics, and patient satisfaction. Bone remodeling and pink esthetic score were analyzed using Wilcoxon signed-rank tests. CSR was calculated using life table analysis. Other soft-tissue outcomes were analyzed using sign tests.

Results: Out of 97 enrolled patients (102 implants), 87 patients (91 implants) completed the 1-year visit. Marginal bone remodeling was -0.85 ± 1.36 mm. After the expected initial bone loss, a mean bone gain of 0.11 ± 1.05 mm was observed between 6 months and 1 year. The CSR was 99.0%, and the cumulative success rate was 97.0%. Partial or full papilla was observed at 30.8% of sites at baseline, 87.2% at 6 months, and 90.5% at 1 year. Soft-tissue response, esthetics, and patient satisfaction all improved during the study period.

Conclusions: Bone gain was observed following the expected initial bone loss, and soft-tissue outcomes improved suggesting favorable tissue response using anodized tapered conical connection implants.

Clinical relevance: Rapid stabilization of bone remodeling and robust papilla regeneration indicate favorable tissue healing promoted by the conical connection, platform-shift design.

Trial registration: clinicaltrials.gov NCT02175550.

Keywords: Anterior maxilla; Conical connection; Immediate temporization; Platform shifting.

Conflict of interest statement

Conflict of interest

Dr. AF received grants from Nobel Biocare while the study was conducted. Dr. WZ received grants from Nobel Biocare while the study was conducted. Dr. WZ also received non-financial support from Straumann, grants, personal fees, non-financial support and others from Nobel Biocare, and personal fees from ZimmerBiomet that were unrelated to this study. Dr. GH received grants and non-financial support from Nobel Biocare while the study was conducted. Dr. CM received grants and non-financial support from Nobel Biocare while the study was conducted. Dr. RB received grants from Nobel Biocare while the study was conducted and personal fees from Nobel Biocare that were unrelated to this study. Dr. RN received grants from Nobel Biocare while the study was conducted and personal fees from Nobel Biocare that were unrelated to this study. Drs. AP, NB, AB, EG, and SC have no conflicts of interest to declare.

Funding

This study was supported by Nobel Biocare Services AG, Kloten, Switzerland (grant T-179).

Ethical approval

All procedures were conducted in accordance with the ethical standards of the institutional and/or national research committees and with the 1964 Helsinki declaration and its later amendments.

Informed consent

All patients provided written informed consent prior to inclusion in the study.

Figures

Fig. 1
Fig. 1
A representative clinical case, position 25. Clinical view and periapical radiograph prior to surgery (a), at implant insertion (b), at final crown delivery (c), and 1 year after implant placement (d)
Fig. 2
Fig. 2
OHIP-14 scores throughout the study. The black marker lines indicate the median and the boxes signify the first and third quartiles. Bars indicate minimum and maximum value. Mean, standard deviation (SD), and sample number per time point (n) are listed below the graph

References

    1. Jivraj S, Chee W. Treatment planning of implants in the aesthetic zone. Br Dent J. 2006;201:77–89. doi: 10.1038/sj.bdj.4813820.
    1. Esposito M, Grusovin MG, Polyzos IP, Felice P, Worthington HV. Timing of implant placement after tooth extraction: immediate, immediate-delayed or delayed implants? A Cochrane systematic review. Eur J Oral Implantol. 2010;3:189–205.
    1. Slagter KW, den Hartog L, Bakker NA, Vissink A, Meijer HJ, Raghoebar GM. Immediate placement of dental implants in the esthetic zone: a systematic review and pooled analysis. J Periodontol. 2014;85:e241–e250. doi: 10.1902/jop.2014.130632.
    1. Khzam N, Arora H, Kim P, Fisher A, Mattheos N, Ivanovski S (2015) A systematic review of soft tissue alterations and aesthetic outcomes following immediate implant placement and restoration of single implants in the anterior maxilla. J Periodontol:1–15. doi:10.1902/jop.2015.150287
    1. Cochran DL. The evidence for immediate loading of implants. J Evid Based Dent Pract. 2006;6:155–163. doi: 10.1016/j.jebdp.2006.04.018.
    1. Javed F, Ahmed HB, Crespi R, Romanos GE. Role of primary stability for successful osseointegration of dental implants: factors of influence and evaluation. Interv Med Appl Sci. 2013;5:162–167.
    1. Canullo L, Fedele GR, Iannello G, Jepsen S. Platform switching and marginal bone-level alterations: the results of a randomized-controlled trial. Clin Oral Implants Res. 2010;21:115–121. doi: 10.1111/j.1600-0501.2009.01867.x.
    1. Canullo L, Iannello G, Netuschil L, Jepsen S. Platform switching and matrix metalloproteinase-8 levels in peri-implant sulcular fluid. Clin Oral Implants Res. 2012;23:556–559. doi: 10.1111/j.1600-0501.2011.02175.x.
    1. Canullo L, Rosa JC, Pinto VS, Francischone CE, Gotz W. Inward-inclined implant platform for the amplified platform-switching concept: 18-month follow-up report of a prospective randomized matched-pair controlled trial. Int J Oral Maxillofac Implants. 2012;27:927–934.
    1. De Angelis N, Nevins ML, Camelo MC, Ono Y, Campailla M, Benedicenti S. Platform switching versus conventional technique: a randomized controlled clinical trial. Int J Periodontics Restorative Dent. 2014;34(Suppl):s75–s79.
    1. Monje A, Pommer B. The concept of platform switching to preserve peri-implant bone level: assessment of methodologic quality of systematic reviews. Int J Oral Maxillofac Implants. 2015;30:1084–1092. doi: 10.11607/jomi.4103.
    1. Noelken R, Neffe BA, Kunkel M, Wagner W. Maintenance of marginal bone support and soft tissue esthetics at immediately provisionalized OsseoSpeed implants placed into extraction sites: 2-year results. Clin Oral Implants Res. 2014;25:214–220. doi: 10.1111/clr.12069.
    1. Noelken R, Oberhansl F, Kunkel M, Wagner W. Immediately provisionalized OsseoSpeed profile implants inserted into extraction sockets: 3-year results. Clin Oral Implants Res. 2015
    1. Strietzel FP, Neumann K, Hertel M. Impact of platform switching on marginal peri-implant bone-level changes. A systematic review and meta-analysis. Clin Oral Implants Res. 2015;26:352–358. doi: 10.1111/clr.12339.
    1. Lazzara RJ, Porter SS. Platform switching: a new concept in implant dentistry for controlling postrestorative crestal bone levels. Int J Periodontics Restorative Dent. 2006;26:9–17.
    1. Maeda Y, Miura J, Taki I, Sogo M. Biomechanical analysis on platform switching: is there any biomechanical rationale? Clin Oral Implants Res. 2007;18:581–584. doi: 10.1111/j.1600-0501.2007.01398.x.
    1. Gultekin BA, Gultekin P, Leblebicioglu B, Basegmez C, Yalcin S. Clinical evaluation of marginal bone loss and stability in two types of submerged dental implants. Int J Oral Maxillofac Implants. 2013;28:815–823. doi: 10.11607/jomi.3087.
    1. Schmitt CM, Nogueira-Filho G, Tenenbaum HC, Lai JY, Brito C, Doring H, Nonhoff J. Performance of conical abutment (Morse Taper) connection implants: a systematic review. J Biomed Mater Res A. 2014;102:552–574. doi: 10.1002/jbm.a.34709.
    1. Mura P. Immediate loading of tapered implants placed in postextraction sockets: retrospective analysis of the 5-year clinical outcome. Clin Implant Dent Relat Res. 2012;14:565–574. doi: 10.1111/j.1708-8208.2010.00297.x.
    1. Ivanoff CJ, Widmark G, Johansson C, Wennerberg A. Histologic evaluation of bone response to oxidized and turned titanium micro-implants in human jawbone. Int J Oral Maxillofac Implants. 2003;18:341–348.
    1. Rocci A, Rocci M, Rocci C, Scoccia A, Gargari M, Martignoni M, Gottlow J, Sennerby L. Immediate loading of Branemark system TiUnite and machined-surface implants in the posterior mandible, part II: a randomized open-ended 9-year follow-up clinical trial. Int J Oral Maxillofac Implants. 2013;28:891–895. doi: 10.11607/jomi.2397.
    1. Pozzi A, Mura P. Immediate loading of conical connection implants: up-to-2-year retrospective clinical and radiologic study. Int J Oral Maxillofac Implants. 2016;31:142–152. doi: 10.11607/jomi.4061.
    1. Pozzi A, Tallarico M, Moy PK. Immediate loading with a novel implant featured by variable-threaded geometry, internal conical connection and platform shifting: three-year results from a prospective cohort study. Eur J Oral Implantol. 2015;8:51–63.
    1. Lekholm U, Zarb G. Patient selection and preparation. Chicago, IL: Book title. Quintessence Publishing Co., Inc; 1985.
    1. van Steenberghe D. Outcomes and their measurement in clinical trials of endosseous oral implants. Ann Periodontol. 1997;2:291–298. doi: 10.1902/annals.1997.2.1.291.
    1. Mombelli A, van Oosten MA, Schurch E, Jr, Land NP. The microbiota associated with successful or failing osseointegrated titanium implants. Oral Microbiol Immunol. 1987;2:145–151. doi: 10.1111/j.1399-302X.1987.tb00298.x.
    1. Jemt T. Regeneration of gingival paillae after single-implant treatment. Int J Periodontics Restor Dent. 1997;17:327–333.
    1. Furhauser R, Florescu D, Benesch T, Haas R, Mailath G, Watzek G. Evaluation of soft tissue around single-tooth implant crowns: the pink esthetic score. Clin Oral Implants Res. 2005;16:639–644. doi: 10.1111/j.1600-0501.2005.01193.x.
    1. Slade GD. Derivation and validation of a short-form oral health impact profile. Community Dent Oral Epidemiol. 1997;25:284–290. doi: 10.1111/j.1600-0528.1997.tb00941.x.
    1. Arnhart C, Kielbassa AM, Martinez-de Fuentes R, Goldstein M, Jackowski J, Lorenzoni M, Maiorana C, Mericske-Stern R, Pozzi A, Rompen E, Sanz M, Strub JR. Comparison of variable-thread tapered implant designs to a standard tapered implant design after immediate loading. A 3-year multicentre randomised controlled trial. Eur J Oral Implantol. 2012;5:123–136.
    1. Roos J, Sennerby L, Lekholm U, Jemt T, Grondahl K, Albrektsson T. A qualitative and quantitative method for evaluating implant success: a 5-year retrospective analysis of the Branemark implant. Int J Oral Maxillofac Implants. 1997;12:504–514.
    1. Atieh MA, Alsabeeha NH, Payne AG, Duncan W, Faggion CM, Esposito M. Interventions for replacing missing teeth: alveolar ridge preservation techniques for dental implant site development. Cochrane Database Syst Rev. 2015;5:Cd010176.
    1. den Hartog L, Raghoebar GM, Stellingsma K, Vissink A, Meijer HJ. Immediate non-occlusal loading of single implants in the aesthetic zone: a randomized clinical trial. J Clin Periodontol. 2011;38:186–194. doi: 10.1111/j.1600-051X.2010.01650.x.
    1. Kielbassa AM, Martinez-de Fuentes R, Goldstein M, Arnhart C, Barlattani A, Jackowski J, Knauf M, Lorenzoni M, Maiorana C, Mericske-Stern R, Rompen E, Sanz M. Randomized controlled trial comparing a variable-thread novel tapered and a standard tapered implant: interim one-year results. J Prosthet Dent. 2009;101:293–305. doi: 10.1016/S0022-3913(09)60060-3.
    1. Meloni SM, De Riu G, Pisano M, Cattina G, Tullio A. Implant treatment software planning and guided flapless surgery with immediate provisional prosthesis delivery in the fully edentulous maxilla. A retrospective analysis of 15 consecutively treated patients. Eur J Oral Implantol. 2010;3:245–251.
    1. Meloni SM, De Riu G, Pisano M, De Riu N, Tullio A. Immediate versus delayed loading of single mandibular molars. One-year results from a randomised controlled trial. Eur J Oral Implantol. 2012;5:345–353.
    1. Meloni SM, De Riu G, Pisano M, Dell'aversana Orabona G, Piombino P, Salzano G, Quarato D, Riccardi E, Belli E, Ungari C. Computer-assisted implant surgery and immediate loading in edentulous ridges with dental fresh extraction sockets. Two years results of a prospective case series study. Eur Rev Med Pharmacol Sci. 2013;17:2968–2973.
    1. Meloni SM, De Riu G, Pisano M, Lolli FM, Deledda A, Campus G, Tullio A. Implant restoration of edentulous jaws with 3D software planning, guided surgery, immediate loading, and CAD-CAM full arch frameworks. Int J Dent. 2013;2013:683423. doi: 10.1155/2013/683423.
    1. Meloni SM, De Riu G, Pisano M, Massarelli O, Tullio A. Computer assisted dental rehabilitation in free flaps reconstructed jaws: one year follow-up of a prospective clinical study. Br J Oral Maxillofac Surg. 2012;50:726–731. doi: 10.1016/j.bjoms.2011.12.006.
    1. Meloni SM, De Riu G, Pisano M, Tullio A. Full arch restoration with computer-assisted implant surgery and immediate loading in edentulous ridges with dental fresh extraction sockets. One year results of 10 consecutively treated patients: guided implant surgery and extraction sockets. J Maxillofac Oral Surg. 2013;12:321–325. doi: 10.1007/s12663-012-0429-8.
    1. Tymstra N, Raghoebar GM, Vissink A, Den Hartog L, Stellingsma K, Meijer HJ. Treatment outcome of two adjacent implant crowns with different implant platform designs in the aesthetic zone: a 1-year randomized clinical trial. J Clin Periodontol. 2011;38:74–85. doi: 10.1111/j.1600-051X.2010.01638.x.
    1. Vasak C, Kohal RJ, Lettner S, Rohner D, Zechner W. Clinical and radiological evaluation of a template-guided (NobelGuide™) treatment concept. Clin Oral Implants Res. 2014;25:116–123. doi: 10.1111/clr.12038.
    1. Weinländer M, Lekovic V, Spadijer-Gostovic S, Milicic B, Wegscheider WA, Piehslinger E. Soft tissue development around abutments with a circular macro-groove in healed sites of partially edentulous posterior maxillae and mandibles: a clinical pilot study. Clin Oral Implants Res. 2011;22:743–752. doi: 10.1111/j.1600-0501.2010.02054.x.
    1. Buser D, Martin W, Belser UC. Optimizing esthetics for implant restorations in the anterior maxilla: anatomic and surgical considerations. Int J Oral Maxillofac Implants. 2004;19(Suppl):43–61.
    1. Esposito M, Grusovin MG, Felice P, Karatzopoulos G, Worthington HV and Coulthard P (2009) Interventions for replacing missing teeth: horizontal and vertical bone augmentation techniques for dental implant treatment. Cochrane Database Syst Rev:Cd003607. doi: 10.1002/14651858.CD003607.pub4
    1. Esposito M, Maghaireh H, Grusovin MG, Ziounas I, Worthington HV. Soft tissue management for dental implants: what are the most effective techniques? A Cochrane systematic review. Eur J Oral Implantol. 2012;5:221–238.
    1. Linkevicius T, Apse P. Influence of abutment material on stability of peri-implant tissues: a systematic review. Int J Oral Maxillofac Implants. 2008;23:449–456.
    1. Sailer I, Philipp A, Zembic A, Pjetursson BE, Hammerle CH, Zwahlen M. A systematic review of the performance of ceramic and metal implant abutments supporting fixed implant reconstructions. Clin Oral Implants Res. 2009;20(Suppl 4):4–31. doi: 10.1111/j.1600-0501.2009.01787.x.
    1. Conrad HJ, Seong W-J, Pesun IJ. Current ceramic materials and systems with clinical recommendations: a systematic review. J Prosthet Dent. 2007;98:389–404. doi: 10.1016/S0022-3913(07)60124-3.
    1. Larsson C, Wennerberg A. The clinical success of zirconia-based crowns: a systematic review. Int J Prosthodont. 2014;27:33–43. doi: 10.11607/ijp.3647.
    1. Sailer I, Muhlemann S, Zwahlen M, Hammerle CH, Schneider D. Cemented and screw-retained implant reconstructions: a systematic review of the survival and complication rates. Clin Oral Implants Res. 2012;23(Suppl 6):163–201. doi: 10.1111/j.1600-0501.2012.02538.x.
    1. Shao J, Zhong B. On the treatment effect in clinical trials with dropout. J Biopharm Stat. 2006;16:25–33. doi: 10.1080/10543400500406488.

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