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

Is Medical Therapy Alone Efficient for the Management of Medication-Related Osteonecrosis of the Jaw Bones (MRONJ) in All Stages?: A Comparative Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06917846
Enrollment
102
Registered
2025-04-09
Start date
2018-01-01
Completion date
2023-01-01
Last updated
2025-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Antibiotics, Bisphosphonate, BRONJ, MRONJ, Osteonecrosis

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.

Detailed description

This study analyzed 116 MRONJ lesions in 102 patients, divided into medical and surgical treatment groups. Sixty patients in medical treatment 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. 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. Outcomes after 12 months were categorized into four healing response groups. (H1) Complete healing: Complete healing with a total coverage of previously exposed bone by the oral mucosa, (H2) Partial healing: Healthy progress for clinical outcomes and downstaging of the lesion according to the AAOMS criteria, (H3) Stable disease: No clinical alterations without any change for the clinical stage of the lesion, (H4) Progressive disease: Deteriorated clinical outcomes following lesion upstaging. Associations between variables and outcomes were assessed using Chi-Square and Fisher's exact tests.

Interventions

None listed

Sponsors

Akdeniz University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Healing status of MRONJ lesions after medical vs surgical treatmentTreatment outcomes were assessed after 12 months.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)

Secondary

MeasureTime frameDescription
Correlation between spontaneous sequestration and healingTreatment outcomes were assessed after 12 months.Spontaneous sequestration of osteonecrotic bone is expected in medically treated patients. Measurement of correlation between spontaneous sequestration and healing outcomes in medically treated MRONJ lesions.
Impact of MRONJ stage on treatment outcomesTreatment outcomes were assessed after 12 months.The impact of MRONJ stage on treatment outcomes, specifically comparing the effectiveness of medical and surgical approaches in different disease stages.
Incidence of secondary osteonecrosisTreatment outcomes were assessed after 12 months.Determination of the incidence of secondary osteonecrosis after surgical treatment, especially in stage 3 MRONJ lesions.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026