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A prospective multicenter evaluation of immediately functionalized tapered conical connection implants for single restorations in maxillary anterior and premolar sites: 3-year results

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Abstract

Objectives

This multicenter prospective clinical trial investigated immediately provisionalized, anodized, conical connection, tapered implants with platform shifting in maxillary anterior and premolar sites.

Materials and methods

Patients requiring single-tooth implant-supported restorations in maxillary anterior and premolar sites were enrolled. Implants were immediately provisionalized and evaluated at insertion, 6 months, and annually thereafter. Outcome measures were marginal bone level change (ΔMBL), cumulative survival rate (CSR), and success rate, soft-tissue parameters, and oral health impact profile (OHIP). ΔMBL and Pink Esthetic Score were analyzed using Wilcoxon signed-rank tests. CSR was calculated using life table analysis. Other soft-tissue parameters were analyzed using sign tests.

Results

Of 94 enrolled patients (99 implants), 84 (88 implants) attended the 3-year follow-up. After an initial bone loss between implant insertion and 6 months (− 0.92 ± 1.23 mm), bone levels stabilized from 6 months to 3 years (0.13 ± 0.94 mm) with no significant change. The 3-year CSR was 98.9%, and the cumulative success rate was 96.9%. Papilla index scores of 2 or 3 were observed at 88.6% of sites at the 3-year visit compared with 32.8% at implant insertion. Improvements were observed for all other outcomes, including bleeding on probing, esthetics, plaque, and OHIP.

Conclusions

This restorative protocol was associated with high primary stability, patient satisfaction, stable bone levels, and an overall improvement of the soft tissue outcomes over a 3-year period.

Clinical relevance

The presented treatment is a viable option for single-tooth restorations of maxillary anterior teeth and premolars with successful short- to mid-long-term clinical outcomes.

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Acknowledgments

Professional writing assistance was provided by Katherine H. Sippel, PhD, at BioScience Writers, LLC.

Funding

This study was supported by Nobel Biocare Services AG, Kloten, Switzerland (grant T-179; clinicaltrials.gov NCT02175550).

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Authors

Corresponding author

Correspondence to Guido Heydecke.

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Conflict of interest

Dr. GH received grants and non-financial support from Nobel Biocare while the study was conducted. Dr. AF received grants from Nobel Biocare while the study was conducted. Dr. WZ received grants from Nobel Biocare while the study was conducted and personal fees from Nobel Biocare unrelated to this study; Dr. WZ also received non-financial support from Straumann; grants, personal fees, non-financial support, and other from Nobel Biocare; and personal fees from Zimmer Biomet that were unrelated to this study. 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. All authors contributed equally to this work.

Informed consent

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

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. Ethical approval was granted by Comitato Etico Independiente, PTV, Rome, Italy (registration number 56/11); Ethical & Independent Review Services (E&I IRB), USA (registration number 11041-07); Ethik Kommission, Landesärztekammer Rheinland-Pfalz, Mainz, Germany (registration number 837.214.11(7756)); Ethik Kommission der Ärztekammer Hamburg, Germany (registration number PV3756); Freiburger ethik kommission, Germany (registration number 011/1203); Ethik Kommission der Medizinischen Universität Wien, Austria (registration number 356/2011); and Ethics Committee, Stomatology University, Belgrade, Serbia (registration number 36/12).

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Heydecke, G., Mirzakhanian, C., Behneke, A. et al. A prospective multicenter evaluation of immediately functionalized tapered conical connection implants for single restorations in maxillary anterior and premolar sites: 3-year results. Clin Oral Invest 23, 1877–1885 (2019). https://doi.org/10.1007/s00784-018-2614-8

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