from 01.01.2015 until now
Stavropol State Medical University (kafedra hirurgicheskoy stomatologii i chelyustno-licevoy hirurgii, assistent)
from 01.01.2023 until now
Stavropol, Stavropol, Russian Federation
City Clinical Emergency Hospital
Stavropol, Stavropol, Russian Federation
Russian Federation
Russian Federation
UDK 61 Медицина. Охрана здоровья
GRNTI 76.29 Клиническая медицина
OKSO 31.02.06 Стоматология профилактическая
BBK 566 Стоматология
BISAC MED016000 Dentistry / General
Subject. The number of patients taking antiresorptive drugs (bisphosphonates and denosumab) is steadily increasing. The need of this group of patients for dental care continues to be high. In this regard, the prevalence of complications of antiresorptive therapy – drug osteonecrosis of the jaws – tends to increase. Therefore, the problem of awareness of doctors and patients on the assessment of the risk of drug osteonecrosis of the jaws and its prevention is of high relevance. The aim of the study is to develop a form of informed voluntary consent for types of dental interventions for patients receiving antiresorptive therapy. Methodology. The analysis of regulatory documents on the procedure for obtaining informed voluntary consent in the Russian Federation, as well as positional documents of the leading communities of maxillofacial surgeons on medicinal osteonecrosis of the jaws (USA, Italy, Japan, South Korea, Austria) was carried out. Results. On the basis of Appendix No. 2 of the Order of the Ministry of Health of the Russian Federation dated November 12, 2021 N 1051n, in accordance with Article 20 of Federal Law No. 323-FZ dated 11/21/2011, a form of informed voluntary consent for types of dental interventions for patients who have indicated a history of taking bisphosphonates and (or) denosumab has been developed. The form contains an explanation of the causal relationship between taking antiresorptive drugs and the onset of medicinal osteonecrosis of the jaws, a description of dental manipulations in terms of the risks of this complication, as well as ways to prevent the disease. Conclusions. The presented form of informed voluntary consent to the types of dental interventions for patients receiving antiresorptive therapy is submitted for discussion by the medical community. Openness and completeness of information, as well as cooperation and sharing of responsibility between the patient and the doctor will lead to positive changes in the problem of prevention of medicinal osteonecrosis of the jaws.
bisphosphonates, denosumab, informed voluntary consent, dental care, osteonecrosis of the jaws
1. Ruggiero S.L., Dodson T.B., Fantasia J. American Association of Oral and Maxillofacial Surgeons. American Association of Oral and Maxillofacial Surgeons position paper on medication-related osteonecrosis of the jaw-2014 update // J. Oral Maxillofac. Surg. - 2014;72(10):1938-1956. doi:https://doi.org/10.1016/j.joms.2014.04.031.
2. Manzyuk L.V., Bagrova S.G., Kopp M.V., Kutukova S.I., Semiglazova T.Yu. Ispol'zovanie osteomodificiruyuschih agentov dlya profilaktiki i lecheniya patologii kostnoy tkani pri zlokachestvennyh novoobrazovaniyah. Zlokachestvennye opuholi: Prakticheskie rekomendacii RUSSCO #3s2. 2017;7:477-485. [L.V. Manzyuk, S.G. Bagrova, M.V. Kopp, S.I. Kutukova, T.Yu. Semiglazova. The use of osteomodifying agents for the prevention and treatment of bone pathology in malignant neoplasms. Malignant tumors : practical recommendations. RUSSCO #3s2. 2017;7:477-485. (In Russ.)]. doi: 10.18 027 / 2224-5057-2018-8-3s2-512-520.
3. Mel'nichenko G.A., Belaya Zh.E., Rozhinskaya L.Ya., Toropcova N.V., Alekseeva L.I., Biryukova E.V., Grebennikova T.A., Dzeranova L.K., Dreval' A.V., Zagorodniy N.V., Il'in A.V., Kryukova I.V., Lesnyak O.M., Mamedova E.O., Nikitinskaya O.A., Pigarova E.A., Rodionova S.S., Skripnikova I.A., Tarbaeva N.V., Farba L.Ya., Coriev T.T., Chernova T.O., Yureneva S.V., Yakushevskaya O.V., Dedov I.I. Federal'nye klinicheskie rekomendacii po diagnostike, lecheniyu i profilaktike osteoporoza. Problemy endokrinologii. 2017;63(6):392-426. [G.A. Mel'nichenko, Zh.E. Belaya, L.Ya. Rozhinskaya, N.V. Toropcova, L.I. Alekseeva, E.V. Biryukova, T.A. Grebennikova, L.K. Dzeranova, A.V. Dreval', N.V. Zagorodnij, A.V. Il'in, I.V. Kryukova, O.M. Lesnyak, E.O. Mamedova, O.A. Nikitinskaya, E.A. Pigarova, S.S. Rodionova, I.A. Skripnikova, N.V. Tarbaeva, L.Ya. Farba, T.T. Coriev, T.O. CHernova, S.V. Yureneva, O.V. Yakushevskaya, I.I. Dedov. Federal clinical guidelines for the diagnosis, treatment and prevention of osteoporosis. Problems of endocrinology. 2017;63(6):392-426. (In Russ.)]. doi:https://doi.org/10.14341/probl2017636392-426.
4. Yoneda T., Hagino T., Sugimoto H. Antiresorptive agent-related osteonecrosis of the jaw: Position Paper 2017 of the Japanese Allied Committee on Osteonecrosis of the Jaw // J. Bone Miner. Metab. - 2017;35(1):6-19. doi:https://doi.org/10.1007/s00774-016-0810-7
5. Bedogni A., Campisi G., Agrillo A., Fusco V. Raccomandazioni clinico-terapeutiche sull’osteonecrosi delle ossa mascellari associata a bisfosfonati e sua prevenzione (by SICMF - SIPMO). ED Cleup SC “Coop. Libraria Editrice Universita di Padova”. 2013:151.
6. Hristoforando D.Yu., Spevak E.M. Effektivnost' raboty vrachebnogo personala po profilaktike i ranney diagnostike lekarstvennogo osteonekroza chelyustey. Gumanitarnoe i mediko-biologicheskoe obrazovanie: problemy, perspektivy, integraciya: materialy yubileynoy nauch.-prakt. konf. s mezhdunar. uchastiem, posvyaschennoy 10-letiyu fakul'teta gumanitarnogo i mediko-biologicheskogo obrazovaniya StGMU, 22 oktyabrya 2021 goda. 2021:279-283. [D.Yu. Christoforando, E.M. Spevak. The effectiveness of the work of medical personnel in the prevention and early diagnosis of medicinal osteonecrosis of the jaws. Humanitarian and biomedical education: problems, prospects, integration: materials of the jubilee scientific and practical conference with the international participation dedicated to the 10th anniversary of the Faculty of Humanities and Biomedical Education of StSMU, October 22, 2021. 2021:279-283. (In Russ.)]. https://elibrary.ru/item.asp?id=47162230
7. Andreeva S.N., Gusarov A.A., Fetisov V.A. Analiz sudebnoy praktiki po grazhdanskim delam, svyazannym s defektami okazaniya stomatologicheskoy pomoschi naseleniyu Rossiyskoy Federacii za period s 1993 po 2017 g. Sudebno-medicinskaya ekspertiza. 2018;61(3):44-48. [S.N. Andreeva, A.A. Gusarov, V.A. Fetisov. Analysis of judicial practice in civil cases related to defects in the provision of dental care to the population of the Russian Federation for the period from 1993 to 2017. Forensic medical examination. 2018;61(3):44-48. (In Russ.)]. https://elibrary.ru/item.asp?id=35135919
8. Prikaz Minzdrava Rossii ot 10.05.2017 № 203n «Ob utverzhdenii kriteriev ocenki kachestva medicinskoy pomoschi» (Zaregistrirovan 17.05.2017 № 46740). [Order of the Ministry of Health of the Russian Federation dated 10.05.2017 No. 203n "On approval of criteria for assessing the quality of medical care" (Registered 17.05.2017 No. 46740). (In Russ.)]. http://publication.pravo.gov.ru/Document/View/0001201705170016
9. Red. Kulakov A.A. Chelyustno-licevaya hirurgiya. Nacional'noe rukovodstvo. Moskva : GEOTAR-Media. 2019:692. [Ed. A.A. Kulakov. Maxillofacial surgery. National Leadership. Moscow : GEOTAR-Media. 2019:692. (In Russ.)]. https://elibrary.ru/item.asp?id=39250717
10. Vagner V.D., Gus'kov A.V. Informirovannoe dobrovol'noe soglasie pacienta na medicinskie vmeshatel'stva - nepremennoe uslovie okazaniya stomatologicheskoy pomoschi. Stomatologiya. 2014;93(4):65-67. [V.D. Wagner, A.V. Guskov. Informed voluntary consent of the patient to medical interventions is an indispensable condition for providing dental care. Dentistry. 2014;93(4):65-67. (In Russ.)]. https://elibrary.ru/item.asp?id=22414606
11. Fomichev E.V., Kirpichnikov M.V., Podol'skiy V.V. Bisfosfonatnyy osteonekroz, oslozhnennyy patologicheskim perelomom nizhney chelyusti. Volgogradskiy nauchn.-med. Zhurn. 2018;3(59):43-45. [E.V. Fomichev, M.V. Kirpichnikov, V.V. Podolsky. Bisphosphonate osteonecrosis complicated by a pathological fracture of the mandible. Volgograd Scientific and Medical Journal. 2018;3(59):43-45. (In Russ.)]. https://elibrary.ru/item.asp?id=36413598
12. Tanna N., Steel C., Stagnell S., Bailey E. Awareness of medication related osteonecrosis of the jaws (MRONJ) amongst general dental practitioners // Br. Dent. J. - 2017;222(2):121-125. doi:https://doi.org/10.1038/sj.bdj.2017.79.
13. Prikaz Ministerstva zdravoohraneniya Rossiyskoy Federacii ot 12.11.2021 № 1051n "Ob utverzhdenii Poryadka dachi informirovannogo dobrovol'nogo soglasiya na medicinskoe vmeshatel'stvo i otkaza ot medicinskogo vmeshatel'stva, formy informirovannogo dobrovol'nogo soglasiya na medicinskoe vmeshatel'stvo i formy otkaza ot medicinskogo vmeshatel'stva» (Zaregistrirovan 25.11.2021 № 65977). [Order of the Ministry of Health of the Russian Federation No. 1051n dated 12.11.2021 "On approval of the Procedure for giving informed voluntary consent to medical intervention and refusal of medical intervention, the form of informed voluntary consent to medical intervention and the form of refusal of medical intervention" (Registered on 25.11.2021 No. 65977). (In Russ.)]. http://publication.pravo.gov.ru/Document/View/0001202111250019
14. Ertel' L.A. Informirovannoe dobrovol'noe soglasie na primenenie lekarstvennyh preparatov: problemy i perspektivy. Medicinskoe pravo: teoriya i praktika. 2017;3;1(5):103-115. [L.A. Ertel. Informed voluntary consent to the use of medicines: problems and prospects. Medical law: theory and practice. 2017;3;1(5):103-115. (In Russ.)]. https://elibrary.ru/item.asp?id=29712615
15. Boyarinova V.I. Pravovoe znachenie informirovannogo dobrovol'nogo soglasiya na medicinskoe vmeshatel'stvo. Vestnik Omskogo universiteta. Seriya «Pravo». 2021;18(1):66-74. [V.I. Boyarinova. The legal significance of informed voluntary consent to medical intervention. Bulletin of Omsk University. The series "Law". 2021;18(1):66-74. (In Russ.)]. https://elibrary.ru/item.asp?id=45604210
16. Federal'nyy zakon ot 21.11.2011 №323-FZ (red. ot 03.07.2016) «Ob osnovah ohrany zdorov'ya grazhdan v Rossiyskoy Federacii». Sobranie zakonodatel'stva RF. 2011;48:6724. [Federal Law No. 323-FZ of 21.11.2011 (as amended on 03.07.2016) "On the basics of public health protection in the Russian Federation". Collection of legislation of the Russian Federation. 2011;48:6724. (In Russ.)]. http://www.consultant.ru/document/cons_doc_LAW_121895/
17. Prikaz Ministerstva zdravoohraneniya i social'nogo razvitiya Rossiyskoy Federacii ot 23.04.2012 №390n «Ob utverzhdenii Perechnya opredelennyh vidov medicinskih vmeshatel'stv, na kotorye grazhdane dayut informirovannoe dobrovol'noe soglasie pri vybore vracha i medicinskoy organizacii dlya polucheniya pervichnoy mediko-sanitarnoy pomoschi». Rossiyskaya gazeta. 2012;109. [Order of the Ministry of Health and Social Development of the Russian Federation No. 390n dated 23.04.2012 "On approval of the List of certain types of medical interventions to which Citizens give informed voluntary consent when choosing a doctor and a medical organization to receive primary health care". Russian newspaper. 2012;109. (In Russ.)]. https://base.garant.ru/70172996/
18. Kim K.M., Rhee Y., Kwon Y.D., Kwon T.G., Lee J.K., Kim D.Y. Medication Related Osteonecrosis of the Jaw: 2015 Position Statement of the Korean Society for Bone and Mineral Research and the Korean Association of Oral and Maxillofacial Surgeons // J. Bone Metab. - 2015;22(4):151-165. doi:https://doi.org/10.11005/jbm.2015.22.4.151.
19. Svejda B., Muschitz Ch., Gruber R., Brandtner Ch., Svejda Ch., Gasser R.W., Santler G., Dimai H.P. Positionspapier zur medikamentenassoziierten Osteonekrose des Kiefers (MRONJ) // Wien Med. Wochenschr. - 2016;166(1-2):68-74. doi:https://doi.org/10.1007/s10354-016-0437-2.
20. Romero-Ruiz M.M., Romero-Serrano M., Serrano-González A., Serrera-Figallo M.Á., Gutiérrez-Pérez J.L., Torres-Lagares D. Proposal for a preventive protocol for medication-related osteonecrosis of the jaw // Med Oral Patol Oral Cir Bucal. - 2021;26(3):314-326. doihttps://doi.org/10.4317/medoral.24197
21. Kabak D.S. Psihologicheskie aspekty v stomatologii. Obschee predstavlenie o komplaentnosti pacientov. Obzor literatury. Stomatologiya dlya vseh. 2018;3:38-41. [D.S. Kabak. Psychological aspects in dentistry. A general idea of patient compliance. Literature review. Dentistry for everyone. 2018;3:38-41. (In Russ.)]. https://elibrary.ru/item.asp?id=35668088
22. Prikaz Ministerstva truda i social'noy zaschity RF ot 10.05.2016 № 227n "Ob utverzhdenii professional'nogo standarta «Vrach-stomatolog» (Zaregistrirovano 2.06.2016 № 42399). [Order of the Ministry of Labor and Social Protection of the Russian Federation dated 10.05.2016 No. 227n "On approval of the professional standard "Dentist" (Registered on 2.06.2016 No. 42399). (In Russ.)]. https://www.garant.ru/products/ipo/prime/doc/71316142/
