Medication Related Osteonecrosis of the JawNCT07464678
Use of Platelet-Rich Fibrin (PRF) in the Management of Medication-Related Osteonecrosis of the Jaw (MRONJ)
A study testing Surgical Application of Platelet-Rich Fibrin (PRF) in people with Medication Related Osteonecrosis of the Jaw, run by Poznan University of Medical Sciences at 1 site in Poland.
Trial summary
Medication-Related Osteonecrosis of the Jaw (MRONJ) is a severe and increasingly prevalent clinical condition, defined as the presence of exposed mandibular or maxillary bone in the oral cavity persisting for at least eight weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medication Related Osteonecrosis of the Jaw
- What is being tested?
- Surgical Application of Platelet-Rich Fibrin (PRF)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 sitePoland
- Study dates
- 15 Mar 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 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) according to the criteria established by the American Association of Oral and Maxillofacial Surgeons (AAOMS).
- patients aged ≥18 years
Who cannot join
- Presence of metastases to the bones of the head and neck.
- History of hematologic disorders, including leukemia or thalassemia.
- Any condition or comorbidity that, in the investigator's judgment, would interfere with the patient's ability to safely participate in the study or comply with the protocol.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, Wielkopolska, 60-355 Poznań
About this study
Official title: Effectiveness of Platelet-Rich Fibrin in the Surgical Management of Medication-Related Osteonecrosis of the Jaw: A Randomized Prospective Study
Medication-Related Osteonecrosis of the Jaw (MRONJ) is a severe and increasingly prevalent clinical condition, defined as the presence of exposed mandibular or maxillary bone in the oral cavity persisting for at least eight weeks. The rising incidence of osteonecrosis of the jaw is closely associated with the widespread use of antiresorptive agents, such as bisphosphonates and denosumab, particularly in patients treated for malignant diseases and metabolic bone disorders.
The condition is frequently accompanied by pain, inflammation, infection, and functional impairment, all of which significantly reduce patients' quality of life. Despite advances in medical management, conservative treatment strategies have demonstrated limited effectiveness, especially in advanced stages of the disease. Surgical intervention, including resection of necrotic bone or segmental bone resection with removal of necrotic tissue, has been shown to provide more favorable outcomes. However, surgical treatment remains associated with a considerable risk of postoperative complications, delayed or impaired wound healing, and recurrence of symptoms.
Read more
One promising adjunctive approach is the use of platelet-rich fibrin (PRF), an autologous biomaterial with documented regenerative and anti-inflammatory properties. PRF has been used in oral and maxillofacial surgery for over a decade and may enhance both soft tissue and bone healing. The application of PRF to fill the post-resection defect and, when necessary, to cover the surgical site in cases of insufficient mucosal tissue has shown encouraging results. Evidence from individual case reports, animal studies, and preliminary clinical trials suggests that PRF may improve wound healing, reduce postoperative complications, and decrease the risk of disease recurrence.
The aim of the present study is to evaluate the effectiveness of PRF as an adjunctive treatment in the surgical management of osteonecrosis of the jaw. Patients will be assessed at predefined follow-up intervals of 14 days, 6 weeks, and 6 months postoperatively. Study participants will be allocated to a control group receiving standard surgical treatment and a study group undergoing surgical treatment supplemented with PRF application. Comparative analysis between the groups will be performed to assess treatment outcomes.
Read the detailed description
Qualification for surgical treatment was based on the decision of a qualified specialist in maxillofacial surgery. During the procedure, a mucoperiosteal flap was elevated to expose the necrotic lesion. Any fistulas present were excised. Necrotic sequestra or necrotically altered bone were removed, and the extent of bone resection was determined based on the presence of bleeding from viable bone. Patients in the study group were operated on according to a protocol in which a PRF clot was applied to the surgical site following removal of the necrotic tissue.
Platelet-Rich Fibrin (PRF) was prepared according to the Choukroun A-PRF+ protocol. A total of 40 mL of autologous venous blood was collected into four 10 mL glass tubes without additives and immediately centrifuged at 1300 rpm for 14 minutes using a PRF Duo Quattro centrifuge (Process for PRF, Nice, France). The surgical wound was closed with sutures, avoiding excessive tissue tension.
All patients received antibiotic prophylaxis consisting of amoxicillin with clavulanic acid (875 mg + 125 mg, twice daily) or clindamycin (600 mg, three times daily) in cases of penicillin allergy, administered 12 hours prior to surgery. Antibiotic therapy was continued for 14 days postoperatively. When microbiological swab results and an antibiogram were available, antibiotic therapy was modified accordingly. Postoperatively, patients were instructed on proper oral hygiene and were prescribed a 0.2% chlorhexidine mouth rinse. All procedures were performed in a standardized manner by surgical teams consisting of a specialist and a resident or two specialists in order to ensure comparability of results.
No patient in the study group reported serious adverse events related to the PRF harvesting procedure. In the postoperative period, patients occasionally reported bruising at the venipuncture site, mild swelling, or minimal pain. Follow-up was conducted in the outpatient clinic according to a predefined standardized protocol, including visits at 14 days, 6 weeks, and 6 months after surgery. During each visit, clinical and radiological parameters were assessed, including soft tissue healing, presence or absence of bone exposure, pain complaints, AAOMS (American Association of Oral and Maxillofacial Surgeons) stage, quality of life, presence of exudate, and radiological findings. Assessments were performed by different members of the clinical team in order to limit subjective bias and increase the reliability of the obtained results.
- Being tested
- Surgical Application of Platelet-Rich Fibrin (PRF)
- Keywords
- PRF, MRONJ, osteonecrosis of the jaw, Platelet Rich Fibrin, Medication Related Osteonecrosis of the Jaw
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical Application of Platelet-Rich Fibrin (PRF)Procedure or surgery
Application of platelet-rich fibrin (PRF) to the surgical site during procedure in patients with medication-related osteonecrosis of the jaw (MRONJ).
| Study group | Role | What they receive |
|---|---|---|
| Surgical Treatment With Platelet-Rich Fibrin (PRF) | Experimental | Patients undergoing surgical treatment for osteonecrosis of the jaw with adjunctive application of platelet-rich fibrin (PRF). Receives: Procedure: Surgical Application of Platelet-Rich Fibrin (PRF) |
| Standard Surgical Treatment | No intervention | Participants undergoing standard surgical treatment for osteonecrosis of the jaw without adjunctive platelet-rich fibrin (PRF) application. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Healing of the Surgical Site in Medication-Related Osteonecrosis of the Jaw (MRONJ)
Clinical healing of the surgical site assessed during standardized intraoral examination and categorized into three predefined groups:
- Complete healing - full mucosal coverage without exposed necrotic bone;
- Partial wound dehiscence <50% of the surgical incision;
- Partial wound dehiscence ≥50% of the surgical incision.
Assessment performed by trained surgeons.
Measured: 14 days post-surgery
Clinical Healing of the Surgical Site in Medication-Related Osteonecrosis of the Jaw (MRONJ)
Clinical healing of the surgical site assessed during standardized intraoral examination and categorized into three predefined groups:
- Complete healing - full mucosal coverage without exposed necrotic bone;
- Partial wound dehiscence <50% of the surgical incision;
- Partial wound dehiscence ≥50% of the surgical incision.
Assessment performed by trained surgeons.
Measured: 6 weeks post-surgery
Clinical Healing of the Surgical Site in Medication-Related Osteonecrosis of the Jaw (MRONJ)
Clinical healing of the surgical site assessed during standardized intraoral examination and categorized into three predefined groups:
- Complete healing - full mucosal coverage without exposed necrotic bone;
- Partial wound dehiscence <50% of the surgical incision;
- Partial wound dehiscence ≥50% of the surgical incision.
Assessment performed by trained surgeons.
Measured: 6 months post-surgery
Secondary outcomes (6)
Health-related quality of life assessed using the EQ-5D Visual Analog Scale (EQ-VAS)
Health-related quality of life assessed using the Polish version of the EQ-5D Visual Analog Scale (EQ-VAS). The EQ-VAS is a patient-reported measure ranging from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.
Patients self-reported their overall health status at baseline (preoperative assessment), 6 weeks post-surgery, and 6 months post-surgery.
Measured: Baseline (pre-surgery), 6 weeks post-surgery, 6 months post-surgery
Preoperative serum C-reactive protein (CRP) concentration
Serum CRP concentration (mg/dL) measured preoperatively (baseline, prior to surgical intervention) using a standard automated biochemical analyzer (Alinity c, Abbott company). Blood samples obtained via venipuncture and analyzed in a certified clinical laboratory.
CRP will be analyzed as a continuous variable in relation to clinical healing of the surgical site assessed 14 days after surgery. Clinical healing will be categorized into three predefined groups:
- Complete healing - full mucosal coverage without exposed necrotic bone;
- Partial wound dehiscence <50% of the surgical incision;
- Partial wound dehiscence ≥50% of the surgical incision.
The association between CRP concentration and wound healing outcomes will be analyzed, including potential interaction with PRF application.
Measured: Baseline (preoperative) only
Preoperative serum total protein concentration
Serum total protein concentration (g/dL) measured preoperatively (baseline, prior to surgical intervention) using a standard automated biochemical analyzer (Alinity c, Abbott company). Blood samples obtained via venipuncture and analyzed in a certified clinical laboratory.
Total protein concentration will be analyzed as a continuous variable in relation to clinical healing of the surgical site assessed 14 days after surgery. Clinical healing will be categorized into three predefined groups:
- Complete healing - full mucosal coverage without exposed necrotic bone;
- Partial wound dehiscence <50% of the surgical incision;
- Partial wound dehiscence ≥50% of the surgical incision.
The association between total protein concentration and wound healing outcomes will be analyzed, including potential interaction with PRF application.
Measured: Baseline (preoperative)
Preoperative weight [kg]
Body weight measured using a calibrated digital medical scale (accuracy ±0.1 kg).
Measured: Baseline (preoperative)
Preoperative white blood cell (WBC) count
White blood cell (WBC) count (×10³/µL) measured preoperatively (baseline, prior to surgical intervention) using an automated hematology analyzer (Sysmex 1000, Sysmex company). Blood samples obtained via venipuncture and analyzed in a certified clinical laboratory.
WBC count will be analyzed as a continuous variable in relation to clinical healing of the surgical site assessed 14 days after surgery. Clinical healing will be categorized into three predefined groups:
- Complete healing - full mucosal coverage without exposed necrotic bone;
- Partial wound dehiscence <50% of the surgical incision;
- Partial wound dehiscence ≥50% of the surgical incision.
The association between WBC count and wound healing outcomes will be analyzed, including potential interaction with PRF application.
Measured: Baseline (preoperative)
Preoperative height [m]
Height measured using a wall-mounted stadiometer (accuracy ±0.5 cm)
Measured: Baseline (preoperative)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start15 Mar 2022
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomized after enrollment using a sealed envelope method. Prior to the initiation of patient recruitment, 50 sequentially numbered, opaque envelopes were prepared by an independent individual not involved in patient recruitment, treatment, or outcome assessment. Each envelope contained a card indicating either "PRF" or "Control." After eligibility confirmation and inclusion in the study, each participant was assigned to the next envelope in sequence, which was then opened to determine group allocation. This procedure ensured allocation concealment and minimized the risk of selection bias.
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aleksy Nowak, Principal investigator, Poznan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07464678
- Sponsor's protocol ID
- 2021_808
- Status last verified
- Jan 2025
- First submitted
- 29 Jan 2026
- Last updated
- 11 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: dentified individual participant data (IPD) may be shared with qualified researchers upon reasonable request. Requests should be directed to the corresponding investigator, and data will be provided in accordance with all applicable ethical and legal regulations.
Publications
Nowak A, Rudzka A, Skrzypczak P, Osmola K, Wyganowska ML. Platelet-Rich Fibrin in Surgical Wound Healing of Medication-Related Osteonecrosis of the Jaw: A Pilot Clinical Study. Int J Mol Sci. 2026 Apr 20;27(8):3654. doi: 10.3390/ijms27083654.
PubMed 42074292
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Platelet-Rich Fibrin in the Surgical Management of Medication-Related Osteonecrosis of the Jaw: A Randomized Prospective Study
- ClinicalTrials.gov ID
- NCT07464678
- Acronym / sponsor ID
- 2021_808
- Keywords
- PRF, MRONJ, osteonecrosis of the jaw, Platelet Rich Fibrin, Medication Related Osteonecrosis of the Jaw
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 11 Mar 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 severe and increasingly prevalent clinical condition, defined as the presence of exposed mandibular or maxillary bone in the oral cavity persisting for at least eight weeks. The rising incidence of osteonecrosis of the jaw is closely associated with the widespread use of antiresorptive agents, such as bisphosphonates and denosumab, particularly in patients treated for malignant diseases and metabolic bone disorders.
The condition is frequently accompanied by pain, inflammation, infection, and functional impairment, all of which significantly reduce patients' quality of life. Despite advances in medical management, conservative treatment strategies have demonstrated limited effectiveness, especially in advanced stages of the disease. Surgical intervention, including resection of necrotic bone or segmental bone resection with removal of necrotic tissue, has been shown to provide more favorable outcomes. However, surgical treatment remains associated with a considerable risk of postoperative complications, delayed or impaired wound healing, and recurrence of symptoms.
One promising adjunctive approach is the use of platelet-rich fibrin (PRF), an autologous biomaterial with documented regenerative and anti-inflammatory properties. PRF has been used in oral and maxillofacial surgery for over a decade and may enhance both soft tissue and bone healing. The application of PRF to fill the post-resection defect and, when necessary, to cover the surgical site in cases of insufficient mucosal tissue has shown encouraging results. Evidence from individual case reports, animal studies, and preliminary clinical trials suggests that PRF may improve wound healing, reduce postoperative complications, and decrease the risk of disease recurrence.
The aim of the present study is to evaluate the effectiveness of PRF as an adjunctive treatment in the surgical management of osteonecrosis of the jaw. Patients will be assessed at predefined follow-up intervals of 14 days, 6 weeks, and 6 months postoperatively. Study participants will be allocated to a control group receiving standard surgical treatment and a study group undergoing surgical treatment supplemented with PRF application. Comparative analysis between the groups will be performed to assess treatment outcomes.
Detailed description
Qualification for surgical treatment was based on the decision of a qualified specialist in maxillofacial surgery. During the procedure, a mucoperiosteal flap was elevated to expose the necrotic lesion. Any fistulas present were excised. Necrotic sequestra or necrotically altered bone were removed, and the extent of bone resection was determined based on the presence of bleeding from viable bone. Patients in the study group were operated on according to a protocol in which a PRF clot was applied to the surgical site following removal of the necrotic tissue.
Platelet-Rich Fibrin (PRF) was prepared according to the Choukroun A-PRF+ protocol. A total of 40 mL of autologous venous blood was collected into four 10 mL glass tubes without additives and immediately centrifuged at 1300 rpm for 14 minutes using a PRF Duo Quattro centrifuge (Process for PRF, Nice, France). The surgical wound was closed with sutures, avoiding excessive tissue tension.
All patients received antibiotic prophylaxis consisting of amoxicillin with clavulanic acid (875 mg + 125 mg, twice daily) or clindamycin (600 mg, three times daily) in cases of penicillin allergy, administered 12 hours prior to surgery. Antibiotic therapy was continued for 14 days postoperatively. When microbiological swab results and an antibiogram were available, antibiotic therapy was modified accordingly. Postoperatively, patients were instructed on proper oral hygiene and were prescribed a 0.2% chlorhexidine mouth rinse. All procedures were performed in a standardized manner by surgical teams consisting of a specialist and a resident or two specialists in order to ensure comparability of results.
No patient in the study group reported serious adverse events related to the PRF harvesting procedure. In the postoperative period, patients occasionally reported bruising at the venipuncture site, mild swelling, or minimal pain. Follow-up was conducted in the outpatient clinic according to a predefined standardized protocol, including visits at 14 days, 6 weeks, and 6 months after surgery. During each visit, clinical and radiological parameters were assessed, including soft tissue healing, presence or absence of bone exposure, pain complaints, AAOMS (American Association of Oral and Maxillofacial Surgeons) stage, quality of life, presence of exudate, and radiological findings. Assessments were performed by different members of the clinical team in order to limit subjective bias and increase the reliability of the obtained results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomized after enrollment using a sealed envelope method. Prior to the initiation of patient recruitment, 50 sequentially numbered, opaque envelopes were prepared by an independent individual not involved in patient recruitment, treatment, or outcome assessment. Each envelope contained a card indicating either "PRF" or "Control." After eligibility confirmation and inclusion in the study, each participant was assigned to the next envelope in sequence, which was then opened to determine group allocation. This procedure ensured allocation concealment and minimized the risk of selection bias.
| Arm | Type | Receives |
|---|---|---|
| Surgical Treatment With Platelet-Rich Fibrin (PRF) | Experimental | Procedure: Surgical Application of Platelet-Rich Fibrin (PRF)Patients undergoing surgical treatment for osteonecrosis of the jaw with adjunctive application of platelet-rich fibrin (PRF). |
| Standard Surgical Treatment | No intervention | –Participants undergoing standard surgical treatment for osteonecrosis of the jaw without adjunctive platelet-rich fibrin (PRF) application. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients diagnosed with medication-related osteonecrosis of the jaw (MRONJ) according to the criteria established by the American Association of Oral and Maxillofacial Surgeons (AAOMS).
- patients aged ≥18 years
Key exclusion criteria (3 listed)
- Presence of metastases to the bones of the head and neck.
- History of hematologic disorders, including leukemia or thalassemia.
- Any condition or comorbidity that, in the investigator's judgment, would interfere with the patient's ability to safely participate in the study or comply with the protocol.
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 |
|---|---|---|
| Surgical Application of Platelet-Rich Fibrin (PRF)Application of platelet-rich fibrin (PRF) to the surgical site during procedure in patients with medication-related osteonecrosis of the jaw (MRONJ). | Procedure or surgery | Surgical Treatment With Platelet-Rich Fibrin (PRF) |
Primary outcome
Clinical Healing of the Surgical Site in Medication-Related Osteonecrosis of the Jaw (MRONJ)
Time frame: 14 days post-surgery
Clinical healing of the surgical site assessed during standardized intraoral examination and categorized into three predefined groups: * Complete healing - full mucosal coverage without exposed necrotic bone; * Partial wound dehiscence <50% of the surgical incision; * Partial wound dehiscence ≥50% of the surgical incision. Assessment performed by trained surgeons.
Clinical Healing of the Surgical Site in Medication-Related Osteonecrosis of the Jaw (MRONJ)
Time frame: 6 weeks post-surgery
Clinical healing of the surgical site assessed during standardized intraoral examination and categorized into three predefined groups: * Complete healing - full mucosal coverage without exposed necrotic bone; * Partial wound dehiscence <50% of the surgical incision; * Partial wound dehiscence ≥50% of the surgical incision. Assessment performed by trained surgeons.
Clinical Healing of the Surgical Site in Medication-Related Osteonecrosis of the Jaw (MRONJ)
Time frame: 6 months post-surgery
Clinical healing of the surgical site assessed during standardized intraoral examination and categorized into three predefined groups: * Complete healing - full mucosal coverage without exposed necrotic bone; * Partial wound dehiscence <50% of the surgical incision; * Partial wound dehiscence ≥50% of the surgical incision. Assessment performed by trained surgeons.
6 secondary outcomes
Health-related quality of life assessed using the EQ-5D Visual Analog Scale (EQ-VAS)
Time frame: Baseline (pre-surgery), 6 weeks post-surgery, 6 months post-surgery
Preoperative serum C-reactive protein (CRP) concentration
Time frame: Baseline (preoperative) only
Preoperative serum total protein concentration
Time frame: Baseline (preoperative)
Preoperative weight [kg]
Time frame: Baseline (preoperative)
Preoperative white blood cell (WBC) count
Time frame: Baseline (preoperative)
Preoperative height [m]
Time frame: Baseline (preoperative)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Derived from this study: PubMed 42074292Nowak A, Rudzka A, Skrzypczak P, Osmola K, Wyganowska ML. Platelet-Rich Fibrin in Surgical Wound Healing of Medication-Related Osteonecrosis of the Jaw: A Pilot Clinical Study. Int J Mol Sci. 2026 Apr 20;27(8):3654. doi: 10.3390/ijms27083654.
- Individual participant dataSharing planned: No. dentified individual participant data (IPD) may be shared with qualified researchers upon reasonable request. Requests should be directed to the corresponding investigator, and data will be provided in accordance with all applicable ethical and legal regulations.
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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. This study is not recruiting at the moment.
Aleksy Nowak principal investigator
Poznan University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical Application of Platelet-Rich Fibrin (PRF) in people with Medication Related Osteonecrosis of the Jaw, run by Poznan University of Medical Sciences at 1 site in Poland.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 11 Mar 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 Poland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Healing of the Surgical Site in Medication-Related Osteonecrosis of the Jaw (MRONJ) (time frame: 14 days post-surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07464678, which also lists 1 linked publication.
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 11 Mar 2026.