Medication Related Osteonecrosis of the JawNCT07435259
Comparing Implant Retention Versus Removal for MRONJ at Implant Sites
A study testing Implant Retention Surgery and Implant Removal Sugery in people with Medication Related Osteonecrosis of the Jaw, run by Kyunghee University Dental Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Medication Related Osteonecrosis of the Jaw
- What is being tested?
- Implant Retention Surgery and Implant Removal Sugery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Apr 2026to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Kyung Hee University Dental Hospital
Seoul, Seoul, 02447
Junghye Hwang, DDS, MS, 82)10-5166-9154, hye867@naver.com
Junho Jung, DDS, PhD, 82)10-9076-9669, ssa204@khu.ac.kr
About this study
Official title: Implant Retention Versus Removal for MRONJ at Implant Sites: A Prospective Study
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.
Read more
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.
Read the detailed description
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).
- 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.
- 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.
- Study Design and Intervention:
- 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.
- 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.
- Outcome Measures:
- 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.
- 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.
- 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.
- 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.
- 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.
- Being tested
- Implant Retention Surgery, Implant Removal Sugery
- Keywords
- Implant-related MRONJ, Peri-implant MRONJ, Dental implant, Peri-implant bone loss, Implant retention, Implant removal, Osteoporosis, Antiresorptive therapy
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implant Retention SurgeryProcedure or surgery
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 Removal SugeryProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Implant Removal Sugery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after surgical treatment
Secondary outcomes (2)
Radiographic stabilization/progression on CBCT
Radiographic changes in peri-implant bone and surrounding lesion assessed on CBCT to determine stabilization versus progression after treatment, with marginal bone changes within approximately 1.0-1.5 mm considered physiologic remodeling and greater loss interpreted as radiographic progression.
Measured: 6 months and 12 months after treatment
Recurrence of MRONJ-related clinical signs
Recurrence of exposed bone, fistula, infection, or other MRONJ-related clinical signs during follow-up.
Measured: Up to 12 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start6 Apr 2026
- Primary completionMar 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication Related Osteonecrosis of the JawStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyunghee University Dental Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- ITI International Team for Implantology, Switzerland
- Responsible party
- Principal investigator, JunhoJung, Kyunghee University Dental Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07435259
- Sponsor's protocol ID
- KH-DT26004
- Status last verified
- Aug 2026
- First submitted
- 20 Feb 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to the small sample size and the inclusion of imaging data, which may increase the risk of participant re-identification. Data sharing was not included in the IRB-approved protocol.
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implant Retention Versus Removal for MRONJ at Implant Sites: A Prospective Study
- ClinicalTrials.gov ID
- NCT07435259
- Acronym / sponsor ID
- KH-DT26004
- Keywords
- Implant-related MRONJ, Peri-implant MRONJ, Dental implant, Peri-implant bone loss, Implant retention, Implant removal, Osteoporosis, Antiresorptive therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Kyunghee University Dental HospitalUniversity, hospital or other
- Collaborators
- ITI International Team for Implantology, Switzerland
- Study start
- 6 Apr 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
- 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.
- 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.
- Study Design and Intervention:
- 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.
- 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.
- Outcome Measures:
- 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.
- 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.
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Implant Retention | Active comparator | Procedure: Implant Retention SurgeryParticipants 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. |
| Implant Removal | Active comparator | Procedure: Implant Removal SugeryParticipants 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implant Retention SurgerySurgical 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. | Procedure or surgery | Implant Retention |
| Implant Removal SugerySurgical 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. | Procedure or surgery | Implant Removal |
Primary outcome
Complete mucosal healing at 6 months after treatment
Time frame: 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.
2 secondary outcomes
Radiographic stabilization/progression on CBCT
Time frame: 6 months and 12 months after treatment
Recurrence of MRONJ-related clinical signs
Time frame: Up to 12 months after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to the small sample size and the inclusion of imaging data, which may increase the risk of participant re-identification. Data sharing was not included in the IRB-approved protocol.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implant Retention Surgery and Implant Removal Sugery in people with Medication Related Osteonecrosis of the Jaw, run by Kyunghee University Dental Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Junghye Hwang, DDS, MS (82)10-5166-9154, hye867@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete mucosal healing at 6 months after treatment (time frame: 6 months after surgical treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.