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临床试验/NCT07435259
NCT07435259招募中不适用

Implant Retention Versus Removal for MRONJ at Implant Sites: A Prospective Study

Kyunghee University Dental Hospital2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年4月6日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
2
主要终点
Complete mucosal healing at 6 months after treatment

研究概览

简要总结

Medication-related osteonecrosis of the jaw (MRONJ) is a condition that can occur in patients who take medications such as antiresorptive drugs for osteoporosis and other bone-related systemic diseases. Although the overall risk is relatively low, the number of affected patients is increasing as the population ages and dental implants are increasingly used to restore chewing function. When MRONJ develops at an implant site, deciding whether to keep or remove the implant becomes a difficult clinical problem.

Current treatment recommendations for MRONJ are mainly based on disease stage. However, in situations where only part of the bone around an implant is affected, and the entire implant surface is not involved, there are no clear, evidence-based criteria to guide the decision between implant retention and implant removal. Some clinicians recommend removing all implants associated with necrotic bone to reduce the risk of recurrence. Others attempt to preserve implants that appear less severely affected. Implant retention may carry a risk of delayed healing or recurrence, whereas implant removal may cause additional surgical trauma that could potentially worsen the condition. Therefore, more objective criteria are needed to support clinical decision-making.

In peri-implantitis, another disease affecting the tissues around implants, the amount of bone loss observed on radiographs is often used as a reference for treatment decisions. Traditionally, implant removal has been considered when bone loss reaches approximately 50-60% of the implant length. When bone loss is less extensive, treatment aimed at preserving the implant may be attempted. However, it is unknown whether a similar bone loss threshold applies to patients with implant-related MRONJ.

The purpose of this prospective study is to evaluate whether the extent of peri-implant bone loss-particularly within the range of 20% to 60% of the implant length-can serve as a practical reference for deciding whether to retain or remove an implant in patients with implant-related MRONJ. By comparing clinical outcomes between implant retention and implant removal within this range of bone loss, this study aims to determine whether a bone-loss-based criterion can support treatment decisions.

The primary outcome of the study is complete mucosal healing at 6 months after treatment. Additional outcomes, including radiographic changes assessed by cone-beam computed tomography (CBCT) and recurrence of MRONJ-related clinical signs, will also be evaluated during the 1-year follow-up period after treatment initiation. CBCT imaging will be performed at 6 and 12 months after treatment to assess bone changes over time. Approximately 50 patients will be enrolled in this single-center prospective study. The findings are expected to provide structured clinical data to guide implant management decisions in patients with implant-related MRONJ.

详细描述

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:

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients diagnosed with medication-related osteonecrosis of the jaw (MRONJ) (AAOMS stage 0, 1, or 2) who have been treated with antiresorptive agents (e.g., bisphosphonates or denosumab) and/or selective estrogen receptor modulators (SERMs).
  • Presence of an MRONJ lesion involving at least one dental implant at the affected site.
  • Radiographic peri-implant bone loss between ≥20% and <60% of the implant length at the most severe area on baseline imaging.
  • No implant mobility.
  • Able and willing to provide written informed consent after receiving an adequate explanation of the study purpose and procedures.

排除标准

  • History of radiotherapy to the head and neck region.
  • Presence of metastatic disease or bone diseases such as multiple myeloma or Paget's disease of the jaw.
  • Current treatment with anti-angiogenic agents (e.g., bevacizumab, ranibizumab, lenalidomide, sunitinib) or immunomodulatory agents (e.g., methotrexate) for cancer therapy.
  • Uncontrolled systemic disease that may contraindicate surgery or impair healing (e.g., uncontrolled diabetes, recent chemotherapy, severe immunosuppression).
  • Refusal of treatment or follow-up, withdrawal of consent, or inability to comply with study procedures.
  • Peri-implant bone loss outside the predefined range (<20% or ≥60%) on preoperative imaging or intraoperative assessment.

研究组 & 干预措施

Implant Removal

Active Comparator

Participants receive a treatment strategy involving surgical removal of the affected implant together with resection of necrotic bone to eliminate the source of infection and promote healing.

干预措施: Implant Removal Sugery (Procedure)

Implant Retention

Active Comparator

Participants receive a treatment strategy aimed at preserving the affected implant when feasible. The approach includes surgical management of necrotic bone and decontamination of the exposed implant surface, with the goal of maintaining implant stability and achieving mucosal healing.

干预措施: Implant Retention Surgery (Procedure)

结局指标

主要结局

Complete mucosal healing at 6 months after treatment

时间窗: 6 months after surgical treatment

Complete resolution of mucosal breakdown with no exposed necrotic bone and no signs of active infection at the treated implant site.

次要结局

  • Radiographic stabilization/progression on CBCT(6 months and 12 months after treatment)
  • Recurrence of MRONJ-related clinical signs(Up to 12 months after treatment)

研究者

发起方
Kyunghee University Dental Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

JunhoJung

Associate Professor

Kyunghee University Dental Hospital

研究点 (2)

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