Medical and Surgical Treatment of MRONJ (Medication-related Osteonecrosis of the Jaw Bones)

NCT06917846 | Completed

• 1 other identifier: 2023/ KAEK-268
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteonecrosis Due to Drugs, Jaw; Osteonecrosis of the Jaw, Bisphosphonate Related; Osteonecrosis of the Jaw, Bisphosphonate Induced

Keywords

Antibiotics; Bisphosphonate; BRONJ; MRONJ; Osteonecrosis

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (3)

• 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.

• Incidence of secondary osteonecrosis

  Treatment outcomes were assessed after 12 months.

Study Arms (2)

Medical treatment group

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.

Surgical treatment group

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Use of antiresorptive and/or antiangiogenic drugs and consequent development of MRONJ.
• Absence of head and neck radiotherapy.
• Presence of necrotic bone in the maxillofacial region for at least 8 weeks.

You may not qualify if:

• Having undergone head and neck radiotherapy.
• Presence of active radiotherapy and/or chemotherapy.
• Missing information in treatment and follow-up records

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Akdeniz University

Antalya, Turkiye, 07070, Turkey (Türkiye)

Location

Related Publications (15)

• 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.

  PMID: 33671429 BACKGROUND

• 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.

  PMID: 25414052 BACKGROUND

• 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.

  PMID: 19880027 BACKGROUND

• 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.

  PMID: 26752221 BACKGROUND

• 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.

  PMID: 20674411 BACKGROUND

• 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.

  PMID: 32178949 BACKGROUND

• 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.

  PMID: 28684074 BACKGROUND

• 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.

  PMID: 22336489 BACKGROUND

• 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.

  PMID: 28585700 BACKGROUND

• 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.

  PMID: 22000426 BACKGROUND

• 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.

  PMID: 27475683 BACKGROUND

• 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.

  PMID: 24630868 BACKGROUND

• 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.

  PMID: 31095928 BACKGROUND

• 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.

  PMID: 30393090 BACKGROUND

• 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.

  PMID: 35300956 BACKGROUND

MeSH Terms

Conditions

Bisphosphonate-Associated Osteonecrosis of the Jaw; Osteonecrosis

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Jaw Diseases; Stomatognathic Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: April 9, 2025
• Study Start: January 1, 2018
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2023
• Last Updated: April 9, 2025

Record last verified: 2025-04

Locations

TU (1)