This is a single-center, prospective study conducted at Kyung Hee University Dental Hospital that compares clinical outcomes between implant retention and implant removal in patients diagnosed with implant-related medication-related osteonecrosis of the jaw (MRONJ).
1. Background and Rationale:
Implant-related MRONJ presents a significant clinical challenge in patients receiving antiresorptive therapy. Although both implant retention and implant removal are currently used as treatment strategies, there is insufficient prospective evidence to compare their clinical effectiveness. Most available data are retrospective and heterogeneous. Therefore, a prospective study is needed to generate structured clinical outcomes and to inform future large-scale comparative research.
2. Study Population:
Eligible participants are adult patients diagnosed with implant-related MRONJ according to established diagnostic criteria. Diagnosis will be based on clinical findings, radiographic evaluation, and the history of the antiresorptive agent. Patients who meet the inclusion criteria and provide informed consent will be prospectively enrolled. Participants with peri-implant MRONJ involving implants with baseline peri-implant bone loss between 20% and 60% on CBCT will be enrolled. Treatment outcomes of implant retention versus removal will be compared to inform decision criteria within this bone-loss range. If multiple implants are involved within a single MRONJ lesion, all affected implants will be included in the analysis.
3\) Study Design and Intervention:
1. Implant Retention Group:
The affected implant will be preserved, and patients will receive conservative management to control infection, remove necrotic bone as indicated, and promote soft-tissue healing. In the implant retention arm, if intraoperative assessment reveals peri-implant bone loss exceeding 60% of the implant length or compromised implant stability, conversion to implant removal may be performed in accordance with predefined protocol criteria.
2. Implant Removal Group:
The affected implant will be surgically removed, followed by appropriate debridement and management of the site to promote resolution of necrotic bone and soft-tissue healing.
Treatment allocation will not be randomized. Decisions will be made based on clinical assessment, disease severity, patient preference, and shared decision-making between the patient and the clinician.
4\) Outcome Measures:
1. Primary Outcome:
The primary endpoint is complete mucosal healing at 6 months after treatment. Complete mucosal healing is defined as full coverage of the previously exposed bone area with intact mucosa and absence of clinical signs of active infection.
2. Secondary Outcomes:
* Radiographic marginal bone changes will be assessed using CBCT at 6 and 12 months after treatment. The 6-month CBCT will serve as the reference image after initial healing. Marginal bone changes within approximately 1.0-1.5 mm will be considered physiologic remodeling; greater bone loss will be interpreted as radiographic progression of MRONJ.
* Recurrence or persistence of MRONJ-related clinical signs and symptoms, including fistula formation, gingival swelling, erythema, suppuration, or exposed bone, during the 1-year follow-up period.
5\) Sample Size and Study Purpose: Approximately 50 patients are expected to be enrolled. As a prospective study, the primary aim is to generate prospective clinical data and evaluate feasibility, clinical trends, and outcome variability. The findings will inform the design and sample size estimation for future larger comparative studies.
6\) Ethical Considerations: This study has been reviewed and approved by the Institutional Review Board of Kyung Hee University Dental Hospital. All participants will provide written informed consent prior to enrollment.
7\) Study Significance: By prospectively comparing implant retention and removal in implant-related MRONJ, this study aims to clarify patterns of clinical outcomes and provide evidence to support decision-making in the management of this complex condition.
