Clinical trial NCT06917846: Medical and Surgical Treatment of MRONJ (Medication-related Osteonecrosis of the Jaw Bones)
Official title: Is Medical Therapy Alone Efficient for the Management of Medication-Related Osteonecrosis of the Jaw Bones (MRONJ) in All Stages?: A Comparative Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteonecrosis Due to Drugs, Jaw
Osteonecrosis of the Jaw, Bisphosphonate Related
Osteonecrosis of the Jaw, Bisphosphonate Induced
Keywords: Antibiotics
Bisphosphonate
BRONJ
MRONJ
Osteonecrosis
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2025-04-09
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Healing status of MRONJ lesions after medical vs surgical treatment
timeFrame: Treatment outcomes were assessed after 12 months.
Secondary outcomes:
measure: Correlation between spontaneous sequestration and healing
timeFrame: Treatment outcomes were assessed after 12 months.
measure: Impact of MRONJ stage on treatment outcomes
timeFrame: Treatment outcomes were assessed after 12 months.
measure: Incidence of secondary osteonecrosis
timeFrame: Treatment outcomes were assessed after 12 months.
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Akdeniz University
state: Turkiye
Study officials:
References:
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