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

Akdeniz University

Status: Completed

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

Study type: Observational

Funder types: Other

Identifiers

NCT06917846

2023/ KAEK-268

Details and patient eligibility

About

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.

Full 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.

Enrollment: 102 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

102 participants in 2 patient groups

Medical treatment group

Description:

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

Description:

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.