Is Medical Therapy Alone Efficient for the Management of Medication-Related Osteonecrosis of the Jaw Bones (MRONJ) in All Stages?: A Comparative Study
Sponsor study identifier
observational
102
1 country
1
Study Start
January 1, 2018
Actual (reported)Primary Completion
January 1, 2020
Actual (reported)Study Completion
January 1, 2023
Actual (reported)MRONJ is an acronym used to describe medication-related osteonecrosis of the jaw bones. It has been reported by the AAOMS that bisphosphonates or denosumab can cause this condition. The management of medication-related osteonecrosis of the jaw (MRONJ) is challenging, and there is ongoing debate over whether medical or surgical treatment is the gold standard. The aim of this retrospective study is to investigate the efficacies of medical and surgical treatments of MRONJ and comparatively evaluate their outcomes.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 1, 2023
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2018
Actual (reported)January 1, 2020
Actual (reported)January 1, 2023
Actual (reported)March 31, 2025
Actual (reported)April 9, 2025
Actual (reported)Healing status of MRONJ lesions after medical vs surgical treatment
To evaluate the effectiveness of medical versus surgical treatment in MRONJ patients by assessing the degree of healing (H1-H4) achieved after treatment. H1: Complete healing H2: Partial healing H3: Stabilization (Stagnation of the disease) H4: Progression (Disease progression)
Treatment outcomes were assessed after 12 months.
Correlation between spontaneous sequestration and healing
Treatment outcomes were assessed after 12 months.
Impact of MRONJ stage on treatment outcomes
Treatment outcomes were assessed after 12 months.
Sixty patients in this group were treated with antibiotherapy following oral hygiene instructions, which included daily chlorhexidine mouthwash recommendation in addition to routine oral hygiene measures. The systemic antibiotherapy spanned 3 weeks. Once the intraoral infection was contained and brought under control, the borders of the necrotic bone were expected to become more prominent and spontaneous sequestration was expected to follow. During follow-up controls, pus formation, pain status, lesion size, presence of spontaneous sequestration and recurrence were evaluated and recorded.
Forty-two patients were treated surgically. During follow-up controls, pus formation, pain status, lesion size, presence of spontaneous sequestration and recurrence were evaluated and recorded.
This retrospective study included 116 MRONJ lesions of different stages in 102 patients, who were referred to Akdeniz University, School of Dentistry, Department of Oral and Maxillofacial Surgery between January 2018 and January 2023. All patients had undergone anti-resorptive and/or anti-angiogenic drug treatment for various systemic diseases.
Akdeniz University
Antalya, Turkiye, 07070, Turkey (Türkiye)
Varoni EM, Lombardi N, Villa G, Pispero A, Sardella A, Lodi G. Conservative Management of Medication-Related Osteonecrosis of the Jaws (MRONJ): A Retrospective Cohort Study. Antibiotics (Basel). 2021 Feb 17;10(2):195. doi: 10.3390/antibiotics10020195.
Khan AA, Morrison A, Hanley DA, Felsenberg D, McCauley LK, O'Ryan F, Reid IR, Ruggiero SL, Taguchi A, Tetradis S, Watts NB, Brandi ML, Peters E, Guise T, Eastell R, Cheung AM, Morin SN, Masri B, Cooper C, Morgan SL, Obermayer-Pietsch B, Langdahl BL, Al Dabagh R, Davison KS, Kendler DL, Sandor GK, Josse RG, Bhandari M, El Rabbany M, Pierroz DD, Sulimani R, Saunders DP, Brown JP, Compston J; International Task Force on Osteonecrosis of the Jaw. Diagnosis and management of osteonecrosis of the jaw: a systematic review and international consensus. J Bone Miner Res. 2015 Jan;30(1):3-23. doi: 10.1002/jbmr.2405.
102 participants (actual enrollment reported by the registry).
First Submitted
March 31, 2025
First Posted
April 9, 2025
Study Start
January 1, 2018
Actual (reported)Medication Related Osteonecrosis of the Jaws (MRONJ) in a Cohort of Patients Treated by Antiresorptive Drugs
Incidence of secondary osteonecrosis
Treatment outcomes were assessed after 12 months.
Contact the study team to confirm eligibility.
Junquera L, Gallego L, Cuesta P, Pelaz A, de Vicente JC. Clinical experiences with bisphosphonate-associated osteonecrosis of the jaws: analysis of 21 cases. Am J Otolaryngol. 2009 Nov-Dec;30(6):390-5. doi: 10.1016/j.amjoto.2008.07.014. Epub 2009 Mar 9.
Mucke T, Jung M, Koerdt S, Mitchell DA, Loeffelbein D, Kesting MR. Free flap reconstruction for patients with bisphosphonate related osteonecrosis of the jaws after mandibulectomy. J Craniomaxillofac Surg. 2016 Feb;44(2):142-7. doi: 10.1016/j.jcms.2015.11.015. Epub 2015 Dec 8.
Wilde F, Heufelder M, Winter K, Hendricks J, Frerich B, Schramm A, Hemprich A. The role of surgical therapy in the management of intravenous bisphosphonates-related osteonecrosis of the jaw. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2011 Feb;111(2):153-63. doi: 10.1016/j.tripleo.2010.04.015. Epub 2010 Jul 31.
Vanpoecke J, Verstraete L, Smeets M, Ferri J, Nicot R, Politis C. Medication-related osteonecrosis of the jaw (MRONJ) stage III: Conservative and conservative surgical approaches versus an aggressive surgical intervention: A systematic review. J Craniomaxillofac Surg. 2020 Apr;48(4):435-443. doi: 10.1016/j.jcms.2020.02.017. Epub 2020 Mar 3. No abstract available.
Zirk M, Kreppel M, Buller J, Pristup J, Peters F, Dreiseidler T, Zinser M, Zoller JE. The impact of surgical intervention and antibiotics on MRONJ stage II and III - Retrospective study. J Craniomaxillofac Surg. 2017 Aug;45(8):1183-1189. doi: 10.1016/j.jcms.2017.05.027. Epub 2017 Jun 4.
Voss PJ, Joshi Oshero J, Kovalova-Muller A, Veigel Merino EA, Sauerbier S, Al-Jamali J, Lemound J, Metzger MC, Schmelzeisen R. Surgical treatment of bisphosphonate-associated osteonecrosis of the jaw: technical report and follow up of 21 patients. J Craniomaxillofac Surg. 2012 Dec;40(8):719-25. doi: 10.1016/j.jcms.2012.01.005. Epub 2012 Feb 14.
Hayashida S, Soutome S, Yanamoto S, Fujita S, Hasegawa T, Komori T, Kojima Y, Miyamoto H, Shibuya Y, Ueda N, Kirita T, Nakahara H, Shinohara M, Umeda M. Evaluation of the Treatment Strategies for Medication-Related Osteonecrosis of the Jaws (MRONJ) and the Factors Affecting Treatment Outcome: A Multicenter Retrospective Study with Propensity Score Matching Analysis. J Bone Miner Res. 2017 Oct;32(10):2022-2029. doi: 10.1002/jbmr.3191. Epub 2017 Jul 11.
Moretti F, Pelliccioni GA, Montebugnoli L, Marchetti C. A prospective clinical trial for assessing the efficacy of a minimally invasive protocol in patients with bisphosphonate-associated osteonecrosis of the jaws. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2011 Dec;112(6):777-82. doi: 10.1016/j.tripleo.2011.07.004. Epub 2011 Oct 14.
Rodriguez-Lozano FJ, Onate-Sanchez RE. Treatment of osteonecrosis of the jaw related to bisphosphonates and other antiresorptive agents. Med Oral Patol Oral Cir Bucal. 2016 Sep 1;21(5):e595-600. doi: 10.4317/medoral.20980.
Carlson ER, Schlott BJ. Anti-resorptive osteonecrosis of the jaws: facts forgotten, questions answered, lessons learned. Oral Maxillofac Surg Clin North Am. 2014 May;26(2):171-91. doi: 10.1016/j.coms.2014.01.005. Epub 2014 Mar 13.
Ozalp O, Toru HS, Altay MA, Sindel A. Evaluation of the Efficacy of EDTA Chelation on Alveolar Bone Healing After Ultrasonic and Conventional Surgery Under Bisphosphonate Medication: A Rat Model. J Oral Maxillofac Surg. 2019 Oct;77(10):1982-1989. doi: 10.1016/j.joms.2019.04.011. Epub 2019 Apr 18.
Nicolatou-Galitis O, Schiodt M, Mendes RA, Ripamonti C, Hope S, Drudge-Coates L, Niepel D, Van den Wyngaert T. Medication-related osteonecrosis of the jaw: definition and best practice for prevention, diagnosis, and treatment. Oral Surg Oral Med Oral Pathol Oral Radiol. 2019 Feb;127(2):117-135. doi: 10.1016/j.oooo.2018.09.008. Epub 2018 Oct 9.
Ruggiero SL, Dodson TB, Aghaloo T, Carlson ER, Ward BB, Kademani D. American Association of Oral and Maxillofacial Surgeons' Position Paper on Medication-Related Osteonecrosis of the Jaws-2022 Update. J Oral Maxillofac Surg. 2022 May;80(5):920-943. doi: 10.1016/j.joms.2022.02.008. Epub 2022 Feb 21.
Bilgin B, Ozalp O, Altay MA, Sindel A. Is medical therapy alone efficient for the management of Medication-related osteonecrosis of the jaw bones (MRONJ) in all stages?: a comparative single-center case-control study. BMC Oral Health. 2025 Jul 5;25(1):1109. doi: 10.1186/s12903-025-06505-1.
Primary Completion
January 1, 2020
Actual (reported)Study Completion
January 1, 2023
Actual (reported)Last Updated
April 9, 2025
Record last verified: 2025-04
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