The clinical trials of dental implants in the form of the analysis and evaluation of the clinical data

Lomakin M.V.

Kafedra rekonstruktivnoĭ khirurgicheskoĭ stomatologii i implantologii fakul'teta poslediplomnogo obrazovaniia Moskovskogo gosudarstvennogo mediko-stomatologicheskogo universiteta

Omarov T.V.

Department of Implantology and Reconstructive Surgery of Oral Cavity Faculty of Stomatology, Moscow State University of Medicine and Dentistry named after A. I. Evdokimov Russian Ministry of Health, Moscow, Russia

The clinical trials of dental implants in the form of the analysis and evaluation of the clinical data

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Lomakin M.V., Omarov T.V.

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Journal: Russian Journal of Stomatology. 2017;10(2): 20‑24

DOI: 10.17116/rosstomat201710220-24

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To cite this article:

Lomakin MV, Omarov TV. The clinical trials of dental implants in the form of the analysis and evaluation of the clinical data. Russian Journal of Stomatology. 2017;10(2):20‑24. (In Russ.)
https://doi.org/10.17116/rosstomat201710220-24

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Experience in the use of zygomatic implants combined with traditional dental implants in the case of severe atrophy of the alveolar process of the upper jaw. Stomatology. 2024;(5):51-56

The stomatological treatment with the application of the dental implants is a component of general medical aid provided with the use of both the simple and sophisticated methods based on the combined, multistep, and time-consuming approach. In the context of dental implantology, the efficacious employment of the available techniques implies the conduction of research designed to further improve the quality of the endosseous implant structure as well as the modification of their surface properties with a view to enhancing their biocompatibility. Material and methods. The present study had the objective to carry out a trial of the medical device (MD) referred to as «the set of the sterile titanium dental implants and the «IDPI-02 — KONMET» instruments for their application in accordance with the technical requirements specification 9437-019-11458417-2013». Results. The results of the study give evidence that the medical device under consideration meets the requirements of the normative technical and operational documentation submitted by the manufacturing company, corresponds to the stated quality, indications for use, effectiveness, and safety of the application for the purpose of practical stomatology at the territory of the Russian Federation.

Keywords:

dental implants

surface biological activity

experimental biological modeling

Authors:

Lomakin M.V.

Kafedra rekonstruktivnoĭ khirurgicheskoĭ stomatologii i implantologii fakul'teta poslediplomnogo obrazovaniia Moskovskogo gosudarstvennogo mediko-stomatologicheskogo universiteta

Omarov T.V.

List of references:

Lomakin MV. Ocenka kachestva dental’nyh implantatov: ot razrabotki do klinicheskogo ispol’zovanija. Doklad na Vserossijskoj nauchno-prakticheskoj konferencii «Medicina i kachestvo 2014». 2 dekabrja 2014 g. (In Russ.)
Smbatjan BS, Volkov AV, Omarov TV, Lomakin MV. Izuchenie osteointgracii implantatov KONMET s bioaktivnoj poverhnost’ju. Rossijskaja stomatologija. 2014;4(7):15-24. (In Russ.) https://doi.org/10.17116/rosstomat20147415-24
Volozhin GA, Tetjuhin DV, Kozlov EN, Stepanova MA, Aljohin AP, Markeev AM. Vlijanie fiziko-himicheskih svojstv poverhnosti titanovyh implantatov i sposobov ih modifikacii na pokazateli osteointegracii. Institut stomatologii. 2009;44(3):81-83. (In Russ.)
Solovyev AA, Markeev AM, Tetyukhin DV, Kozlov EN, Molchanov SA. Applications of anatomic layer deposition in implant dentistry. European Cells and Materials. 2014;2(27):17. (In Russ.)
Smabatyan BS, Volkov AV, Omarov TV, Lomakin MV, Tetyukhin MV, Zolotukhin EA, Molchanov SA. Evaluation of implant surfact coating bioactivity obtained by atomic layer deposition technique. European Cells and Materials. 2015;2(29):26. (In Russ.) https://doi.org/10.1007/978-1-4614-8054-9_10
Prikaz MZ RF №2n ot 09.01.2014g. «Ob utverzhdenii porjadka provedenija ocenki sootvetstvija medicinskih izdelij v forme tehnicheskih ispytanij, toksikologicheskih issledovanij, klinicheskih ispytanij v celjah gosudarstvennoj registracii medicinskih izdelij». (Zaregistrirovano v Minjuste Rossii 03.04.2014 N 31813) (In Russ.)
ISO.org (internet-resurs, 2010/2016).
Smith D, Zarb GA. Crhriteria for Success of Osseointegrated Endoosseous Implants. J Prosthet Dent. 1989;62:567-572. https://doi.org/10.1016/0022-3913(89)90081-4

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