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NCT Number: NCT06917846

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Healing status of MRONJ lesions after medical vs surgical treatment

    Time frame: Treatment 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 outcomes

  1. Correlation between spontaneous sequestration and healing

    Time frame: Treatment 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.

  2. Impact of MRONJ stage on treatment outcomes

    Time frame: Treatment 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.

  3. Incidence of secondary osteonecrosis

    Time frame: Treatment outcomes were assessed after 12 months.

    Determination of the incidence of secondary osteonecrosis after surgical treatment, especially in stage 3 MRONJ lesions.

Sponsors and collaborators

Lead sponsor

Akdeniz University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2023
First posted
Apr 9, 2025
Registry last updated
Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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