Trials / Completed
CompletedNCT06917846
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
- Phase
- —
- Study type
- Observational
- Enrollment
- 102 (actual)
- Sponsor
- Akdeniz University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Osteonecrosis Due to Drugs, Jaw
- Osteonecrosis of the Jaw, Bisphosphonate Related
- Osteonecrosis of the Jaw, Bisphosphonate Induced
Timeline
- Start date
- 2018-01-01
- Primary completion
- 2020-01-01
- Completion
- 2023-01-01
- First posted
- 2025-04-09
- Last updated
- 2025-04-09
Locations
1 site across 1 country: Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT06917846. Inclusion in this directory is not an endorsement.