Comparing Implant Retention Versus Removal for MRONJ at Implant Sites

NCT07435259 | Not Yet Recruiting

• 1 other identifier: KH-DT26004
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Medication Related Osteonecrosis of the Jaw

Keywords

Implant-related MRONJ; Peri-implant MRONJ; Dental implant; Peri-implant bone loss; Implant retention; Implant removal; Osteoporosis; Antiresorptive therapy

Outcome Measures

Primary Outcomes (1)

• Complete mucosal healing at 6 months after treatment

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

  6 months after surgical treatment

Secondary Outcomes (2)

• Radiographic stabilization/progression on CBCT

  6 months and 12 months after treatment

• Recurrence of MRONJ-related clinical signs

  Up to 12 months after treatment

Study Arms (2)

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.

Procedure: Implant Retention Surgery

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.

Procedure: Implant Removal Sugery

Interventions

Implant Retention Surgery PROCEDURE

Surgical removal of necrotic bone surrounding the affected implant is performed. The exposed implant surface is mechanically decontaminated (e.g., using a titanium brush) to reduce biofilm contamination. The surgical site is managed to promote mucosal healing and infection control while preserving implant stability.

Implant Retention

Implant Removal Sugery PROCEDURE

Surgical extraction of the affected implant is performed along with the removal of surrounding necrotic bone. The surgical site is managed to promote mucosal healing and stabilization of the underlying bone.

Implant Removal

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kyunghee University Dental Hospital: lead
• ITI International Team for Implantology, Switzerland: collaborator

Study Sites (1)

Kyung Hee University Dental Hospital

Seoul, Seoul, 02447, South Korea

Location

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Junghye Hwang, DDS, MS

CONTACT

82)10-5166-9154; hye867@naver.com

Junho Jung, DDS, PhD

CONTACT

82)10-9076-9669; ssa204@khu.ac.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Non-randomized, two-arm parallel assignment study. Participants receive implant retention or implant removal based on clinical assessment and shared decision-making (patient preference and clinician judgment).

Study Record Dates

• First Submitted: February 20, 2026
• First Posted: February 27, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)