Osteonecrosis Due to Drugs, JawNCT06917846
Medical and Surgical Treatment of MRONJ (Medication-related Osteonecrosis of the Jaw Bones)
An observational study of Osteonecrosis Due to Drugs, Jaw and Osteonecrosis of the Jaw, Bisphosphonate Related, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
MRONJ is an acronym used to describe medication-related osteonecrosis of the jaw bones. It has been reported by the AAOMS that bisphosphonates or denosumab can cause this condition. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteonecrosis Due to Drugs, Jaw, Osteonecrosis of the Jaw, Bisphosphonate Related, Osteonecrosis of the Jaw, Bisphosphonate Induced
- Type of treatment
- Pill or oral medicine
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2018to 1 Jan 2023
- Phase
- Observational
- 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
Study population: This retrospective study included 116 MRONJ lesions of different stages in 102 patients, who were referred to Akdeniz University, School of Dentistry, Department of Oral and Maxillofacial Surgery between January 2018 and January 2023. All patients had undergone anti-resorptive and/or anti-angiogenic drug treatment for various systemic diseases.
Who may be able to join
- Use of antiresorptive and/or antiangiogenic drugs and consequent development of MRONJ.
- Absence of head and neck radiotherapy.
- Presence of necrotic bone in the maxillofacial region for at least 8 weeks.
Who cannot join
- Having undergone head and neck radiotherapy.
- Presence of active radiotherapy and/or chemotherapy.
- Missing information in treatment and follow-up records
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is Medical Therapy Alone Efficient for the Management of Medication-Related Osteonecrosis of the Jaw Bones (MRONJ) in All Stages?: A Comparative Study
MRONJ is an acronym used to describe medication-related osteonecrosis of the jaw bones. It has been reported by the AAOMS that bisphosphonates or denosumab can cause this condition. The management of medication-related osteonecrosis of the jaw (MRONJ) is challenging, and there is ongoing debate over whether medical or surgical treatment is the gold standard. The aim of this retrospective study is to investigate the efficacies of medical and surgical treatments of MRONJ and comparatively evaluate their outcomes.
Read the detailed description
This study analyzed 116 MRONJ lesions in 102 patients, divided into medical and surgical treatment groups. Sixty patients in medical treatment group were treated with antibiotherapy following oral hygiene instructions, which included daily chlorhexidine mouthwash recommendation in addition to routine oral hygiene measures.The systemic antibiotherapy spanned 3 weeks. Once the intraoral infection was contained and brought under control, the borders of the necrotic bone were expected to become more prominent and spontaneous sequestration was expected to follow. Forty-two patients were treated surgically. During follow-up controls, pus formation, pain status, lesion size, presence of spontaneous sequestration and recurrence were evaluated and recorded. Outcomes after 12 months were categorized into four healing response groups. (H1) Complete healing: Complete healing with a total coverage of previously exposed bone by the oral mucosa, (H2) Partial healing: Healthy progress for clinical outcomes and downstaging of the lesion according to the AAOMS criteria, (H3) Stable disease: No clinical alterations without any change for the clinical stage of the lesion, (H4) Progressive disease: Deteriorated clinical outcomes following lesion upstaging.
Associations between variables and outcomes were assessed using Chi-Square and Fisher's exact tests.
- Conditions
- Osteonecrosis Due to Drugs, Jaw, Osteonecrosis of the Jaw, Bisphosphonate Related, Osteonecrosis of the Jaw, Bisphosphonate Induced
- Keywords
- Antibiotics, Bisphosphonate, BRONJ, MRONJ, Osteonecrosis
- Medical subject headings
- Bisphosphonate-Associated Osteonecrosis of the Jaw, Osteonecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Medical treatment group | Sixty patients in this group were treated with antibiotherapy following oral hygiene instructions, which included daily chlorhexidine mouthwash recommendation in addition to routine oral hygiene measures. The systemic antibiotherapy spanned 3 weeks. Once the intraoral infection was contained and brought under control, the borders of the necrotic bone were expected to become more prominent and spontaneous sequestration was expected to follow. During follow-up controls, pus formation, pain status, lesion size, presence of spontaneous sequestration and recurrence were evaluated and recorded. | |
| Surgical treatment group | Forty-two patients were treated surgically. During follow-up controls, pus formation, pain status, lesion size, presence of spontaneous sequestration and recurrence were evaluated and recorded. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing status of MRONJ lesions after medical vs surgical treatment
To evaluate the effectiveness of medical versus surgical treatment in MRONJ patients by assessing the degree of healing (H1-H4) achieved after treatment.
H1: Complete healing H2: Partial healing H3: Stabilization (Stagnation of the disease) H4: Progression (Disease progression)
Measured: Treatment outcomes were assessed after 12 months.
Secondary outcomes (3)
Correlation between spontaneous sequestration and healing
Spontaneous sequestration of osteonecrotic bone is expected in medically treated patients. Measurement of correlation between spontaneous sequestration and healing outcomes in medically treated MRONJ lesions.
Measured: Treatment outcomes were assessed after 12 months.
Impact of MRONJ stage on treatment outcomes
The impact of MRONJ stage on treatment outcomes, specifically comparing the effectiveness of medical and surgical approaches in different disease stages.
Measured: Treatment outcomes were assessed after 12 months.
Incidence of secondary osteonecrosis
Determination of the incidence of secondary osteonecrosis after surgical treatment, especially in stage 3 MRONJ lesions.
Measured: Treatment outcomes were assessed after 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start1 Jan 2018
- Primary completion1 Jan 2020
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Osteonecrosis Due to Drugs, JawStudies of the same condition, open and under way.
- More trials run by Akdeniz UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alper Sindel, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06917846
- Sponsor's protocol ID
- 2023/ KAEK-268
- Status last verified
- Apr 2025
- First submitted
- 31 Mar 2025
- Last updated
- 9 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Varoni EM, Lombardi N, Villa G, Pispero A, Sardella A, Lodi G. Conservative Management of Medication-Related Osteonecrosis of the Jaws (MRONJ): A Retrospective Cohort Study. Antibiotics (Basel). 2021 Feb 17;10(2):195. doi: 10.3390/antibiotics10020195.
PubMed 33671429Khan AA, Morrison A, Hanley DA, Felsenberg D, McCauley LK, O'Ryan F, Reid IR, Ruggiero SL, Taguchi A, Tetradis S, Watts NB, Brandi ML, Peters E, Guise T, Eastell R, Cheung AM, Morin SN, Masri B, Cooper C, Morgan SL, Obermayer-Pietsch B, Langdahl BL, Al Dabagh R, Davison KS, Kendler DL, Sandor GK, Josse RG, Bhandari M, El Rabbany M, Pierroz DD, Sulimani R, Saunders DP, Brown JP, Compston J; International Task Force on Osteonecrosis of the Jaw. Diagnosis and management of osteonecrosis of the jaw: a systematic review and international consensus. J Bone Miner Res. 2015 Jan;30(1):3-23. doi: 10.1002/jbmr.2405.
PubMed 25414052Junquera L, Gallego L, Cuesta P, Pelaz A, de Vicente JC. Clinical experiences with bisphosphonate-associated osteonecrosis of the jaws: analysis of 21 cases. Am J Otolaryngol. 2009 Nov-Dec;30(6):390-5. doi: 10.1016/j.amjoto.2008.07.014. Epub 2009 Mar 9.
PubMed 19880027Mucke T, Jung M, Koerdt S, Mitchell DA, Loeffelbein D, Kesting MR. Free flap reconstruction for patients with bisphosphonate related osteonecrosis of the jaws after mandibulectomy. J Craniomaxillofac Surg. 2016 Feb;44(2):142-7. doi: 10.1016/j.jcms.2015.11.015. Epub 2015 Dec 8.
PubMed 26752221Wilde F, Heufelder M, Winter K, Hendricks J, Frerich B, Schramm A, Hemprich A. The role of surgical therapy in the management of intravenous bisphosphonates-related osteonecrosis of the jaw. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2011 Feb;111(2):153-63. doi: 10.1016/j.tripleo.2010.04.015. Epub 2010 Jul 31.
PubMed 20674411Vanpoecke J, Verstraete L, Smeets M, Ferri J, Nicot R, Politis C. Medication-related osteonecrosis of the jaw (MRONJ) stage III: Conservative and conservative surgical approaches versus an aggressive surgical intervention: A systematic review. J Craniomaxillofac Surg. 2020 Apr;48(4):435-443. doi: 10.1016/j.jcms.2020.02.017. Epub 2020 Mar 3. No abstract available.
PubMed 32178949Zirk M, Kreppel M, Buller J, Pristup J, Peters F, Dreiseidler T, Zinser M, Zoller JE. The impact of surgical intervention and antibiotics on MRONJ stage II and III - Retrospective study. J Craniomaxillofac Surg. 2017 Aug;45(8):1183-1189. doi: 10.1016/j.jcms.2017.05.027. Epub 2017 Jun 4.
PubMed 28684074Voss PJ, Joshi Oshero J, Kovalova-Muller A, Veigel Merino EA, Sauerbier S, Al-Jamali J, Lemound J, Metzger MC, Schmelzeisen R. Surgical treatment of bisphosphonate-associated osteonecrosis of the jaw: technical report and follow up of 21 patients. J Craniomaxillofac Surg. 2012 Dec;40(8):719-25. doi: 10.1016/j.jcms.2012.01.005. Epub 2012 Feb 14.
PubMed 22336489Hayashida S, Soutome S, Yanamoto S, Fujita S, Hasegawa T, Komori T, Kojima Y, Miyamoto H, Shibuya Y, Ueda N, Kirita T, Nakahara H, Shinohara M, Umeda M. Evaluation of the Treatment Strategies for Medication-Related Osteonecrosis of the Jaws (MRONJ) and the Factors Affecting Treatment Outcome: A Multicenter Retrospective Study with Propensity Score Matching Analysis. J Bone Miner Res. 2017 Oct;32(10):2022-2029. doi: 10.1002/jbmr.3191. Epub 2017 Jul 11.
PubMed 28585700Moretti F, Pelliccioni GA, Montebugnoli L, Marchetti C. A prospective clinical trial for assessing the efficacy of a minimally invasive protocol in patients with bisphosphonate-associated osteonecrosis of the jaws. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2011 Dec;112(6):777-82. doi: 10.1016/j.tripleo.2011.07.004. Epub 2011 Oct 14.
PubMed 22000426Rodriguez-Lozano FJ, Onate-Sanchez RE. Treatment of osteonecrosis of the jaw related to bisphosphonates and other antiresorptive agents. Med Oral Patol Oral Cir Bucal. 2016 Sep 1;21(5):e595-600. doi: 10.4317/medoral.20980.
PubMed 27475683Carlson ER, Schlott BJ. Anti-resorptive osteonecrosis of the jaws: facts forgotten, questions answered, lessons learned. Oral Maxillofac Surg Clin North Am. 2014 May;26(2):171-91. doi: 10.1016/j.coms.2014.01.005. Epub 2014 Mar 13.
PubMed 24630868Ozalp O, Toru HS, Altay MA, Sindel A. Evaluation of the Efficacy of EDTA Chelation on Alveolar Bone Healing After Ultrasonic and Conventional Surgery Under Bisphosphonate Medication: A Rat Model. J Oral Maxillofac Surg. 2019 Oct;77(10):1982-1989. doi: 10.1016/j.joms.2019.04.011. Epub 2019 Apr 18.
PubMed 31095928Nicolatou-Galitis O, Schiodt M, Mendes RA, Ripamonti C, Hope S, Drudge-Coates L, Niepel D, Van den Wyngaert T. Medication-related osteonecrosis of the jaw: definition and best practice for prevention, diagnosis, and treatment. Oral Surg Oral Med Oral Pathol Oral Radiol. 2019 Feb;127(2):117-135. doi: 10.1016/j.oooo.2018.09.008. Epub 2018 Oct 9.
PubMed 30393090Ruggiero SL, Dodson TB, Aghaloo T, Carlson ER, Ward BB, Kademani D. American Association of Oral and Maxillofacial Surgeons' Position Paper on Medication-Related Osteonecrosis of the Jaws-2022 Update. J Oral Maxillofac Surg. 2022 May;80(5):920-943. doi: 10.1016/j.joms.2022.02.008. Epub 2022 Feb 21.
PubMed 35300956
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Medical Therapy Alone Efficient for the Management of Medication-Related Osteonecrosis of the Jaw Bones (MRONJ) in All Stages?: A Comparative Study
- ClinicalTrials.gov ID
- NCT06917846
- Acronym / sponsor ID
- 2023/ KAEK-268
- Conditions
- Osteonecrosis Due to Drugs, Jaw, Osteonecrosis of the Jaw, Bisphosphonate Related, Osteonecrosis of the Jaw, Bisphosphonate Induced
- Keywords
- Antibiotics, Bisphosphonate, BRONJ, MRONJ, Osteonecrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 9 Apr 2025 (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.
MRONJ is an acronym used to describe medication-related osteonecrosis of the jaw bones. It has been reported by the AAOMS that bisphosphonates or denosumab can cause this condition. The management of medication-related osteonecrosis of the jaw (MRONJ) is challenging, and there is ongoing debate over whether medical or surgical treatment is the gold standard. The aim of this retrospective study is to investigate the efficacies of medical and surgical treatments of MRONJ and comparatively evaluate their outcomes.
Detailed description
This study analyzed 116 MRONJ lesions in 102 patients, divided into medical and surgical treatment groups. Sixty patients in medical treatment group were treated with antibiotherapy following oral hygiene instructions, which included daily chlorhexidine mouthwash recommendation in addition to routine oral hygiene measures.The systemic antibiotherapy spanned 3 weeks. Once the intraoral infection was contained and brought under control, the borders of the necrotic bone were expected to become more prominent and spontaneous sequestration was expected to follow. Forty-two patients were treated surgically. During follow-up controls, pus formation, pain status, lesion size, presence of spontaneous sequestration and recurrence were evaluated and recorded. Outcomes after 12 months were categorized into four healing response groups. (H1) Complete healing: Complete healing with a total coverage of previously exposed bone by the oral mucosa, (H2) Partial healing: Healthy progress for clinical outcomes and downstaging of the lesion according to the AAOMS criteria, (H3) Stable disease: No clinical alterations without any change for the clinical stage of the lesion, (H4) Progressive disease: Deteriorated clinical outcomes following lesion upstaging.
Associations between variables and outcomes were assessed using Chi-Square and Fisher's exact tests.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medical treatment group | – | –Sixty patients in this group were treated with antibiotherapy following oral hygiene instructions, which included daily chlorhexidine mouthwash recommendation in addition to routine oral hygiene measures. The systemic antibiotherapy spanned 3 weeks. Once the intraoral infection was contained and brought under control, the borders of the necrotic bone were expected to become more prominent and spontaneous sequestration was expected to follow. During follow-up controls, pus formation, pain status, lesion size, presence of spontaneous sequestration and recurrence were evaluated and recorded. |
| Surgical treatment group | – | –Forty-two patients were treated surgically. During follow-up controls, pus formation, pain status, lesion size, presence of spontaneous sequestration and recurrence were evaluated and recorded. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This retrospective study included 116 MRONJ lesions of different stages in 102 patients, who were referred to Akdeniz University, School of Dentistry, Department of Oral and Maxillofacial Surgery between January 2018 and January 2023. All patients had undergone anti-resorptive and/or anti-angiogenic drug treatment for various systemic diseases.
Key inclusion criteria (3 listed)
- Use of antiresorptive and/or antiangiogenic drugs and consequent development of MRONJ.
- Absence of head and neck radiotherapy.
- Presence of necrotic bone in the maxillofacial region for at least 8 weeks.
Key exclusion criteria (3 listed)
- Having undergone head and neck radiotherapy.
- Presence of active radiotherapy and/or chemotherapy.
- Missing information in treatment and follow-up records
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Healing status of MRONJ lesions after medical vs surgical treatment
Time frame: Treatment outcomes were assessed after 12 months.
To evaluate the effectiveness of medical versus surgical treatment in MRONJ patients by assessing the degree of healing (H1-H4) achieved after treatment. H1: Complete healing H2: Partial healing H3: Stabilization (Stagnation of the disease) H4: Progression (Disease progression)
3 secondary outcomes
Correlation between spontaneous sequestration and healing
Time frame: Treatment outcomes were assessed after 12 months.
Impact of MRONJ stage on treatment outcomes
Time frame: Treatment outcomes were assessed after 12 months.
Incidence of secondary osteonecrosis
Time frame: Treatment outcomes were assessed after 12 months.
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 9 Apr 2025.
- Background: PubMed 33671429Varoni EM, Lombardi N, Villa G, Pispero A, Sardella A, Lodi G. Conservative Management of Medication-Related Osteonecrosis of the Jaws (MRONJ): A Retrospective Cohort Study. Antibiotics (Basel). 2021 Feb 17;10(2):195. doi: 10.3390/antibiotics10020195.
- Background: PubMed 25414052Khan AA, Morrison A, Hanley DA, Felsenberg D, McCauley LK, O'Ryan F, Reid IR, Ruggiero SL, Taguchi A, Tetradis S, Watts NB, Brandi ML, Peters E, Guise T, Eastell R, Cheung AM, Morin SN, Masri B, Cooper C, Morgan SL, Obermayer-Pietsch B, Langdahl BL, Al Dabagh R, Davison KS, Kendler DL, Sandor GK, Josse RG, Bhandari M, El Rabbany M, Pierroz DD, Sulimani R, Saunders DP, Brown JP, Compston J; International Task Force on Osteonecrosis of the Jaw. Diagnosis and management of osteonecrosis of the jaw: a systematic review and international consensus. J Bone Miner Res. 2015 Jan;30(1):3-23. doi: 10.1002/jbmr.2405.
- Background: PubMed 19880027Junquera L, Gallego L, Cuesta P, Pelaz A, de Vicente JC. Clinical experiences with bisphosphonate-associated osteonecrosis of the jaws: analysis of 21 cases. Am J Otolaryngol. 2009 Nov-Dec;30(6):390-5. doi: 10.1016/j.amjoto.2008.07.014. Epub 2009 Mar 9.
- Background: PubMed 26752221Mucke T, Jung M, Koerdt S, Mitchell DA, Loeffelbein D, Kesting MR. Free flap reconstruction for patients with bisphosphonate related osteonecrosis of the jaws after mandibulectomy. J Craniomaxillofac Surg. 2016 Feb;44(2):142-7. doi: 10.1016/j.jcms.2015.11.015. Epub 2015 Dec 8.
- Background: PubMed 20674411Wilde F, Heufelder M, Winter K, Hendricks J, Frerich B, Schramm A, Hemprich A. The role of surgical therapy in the management of intravenous bisphosphonates-related osteonecrosis of the jaw. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2011 Feb;111(2):153-63. doi: 10.1016/j.tripleo.2010.04.015. Epub 2010 Jul 31.
- Background: PubMed 32178949Vanpoecke J, Verstraete L, Smeets M, Ferri J, Nicot R, Politis C. Medication-related osteonecrosis of the jaw (MRONJ) stage III: Conservative and conservative surgical approaches versus an aggressive surgical intervention: A systematic review. J Craniomaxillofac Surg. 2020 Apr;48(4):435-443. doi: 10.1016/j.jcms.2020.02.017. Epub 2020 Mar 3. No abstract available.
- Background: PubMed 28684074Zirk M, Kreppel M, Buller J, Pristup J, Peters F, Dreiseidler T, Zinser M, Zoller JE. The impact of surgical intervention and antibiotics on MRONJ stage II and III - Retrospective study. J Craniomaxillofac Surg. 2017 Aug;45(8):1183-1189. doi: 10.1016/j.jcms.2017.05.027. Epub 2017 Jun 4.
- Background: PubMed 22336489Voss PJ, Joshi Oshero J, Kovalova-Muller A, Veigel Merino EA, Sauerbier S, Al-Jamali J, Lemound J, Metzger MC, Schmelzeisen R. Surgical treatment of bisphosphonate-associated osteonecrosis of the jaw: technical report and follow up of 21 patients. J Craniomaxillofac Surg. 2012 Dec;40(8):719-25. doi: 10.1016/j.jcms.2012.01.005. Epub 2012 Feb 14.
- Background: PubMed 28585700Hayashida S, Soutome S, Yanamoto S, Fujita S, Hasegawa T, Komori T, Kojima Y, Miyamoto H, Shibuya Y, Ueda N, Kirita T, Nakahara H, Shinohara M, Umeda M. Evaluation of the Treatment Strategies for Medication-Related Osteonecrosis of the Jaws (MRONJ) and the Factors Affecting Treatment Outcome: A Multicenter Retrospective Study with Propensity Score Matching Analysis. J Bone Miner Res. 2017 Oct;32(10):2022-2029. doi: 10.1002/jbmr.3191. Epub 2017 Jul 11.
- Background: PubMed 22000426Moretti F, Pelliccioni GA, Montebugnoli L, Marchetti C. A prospective clinical trial for assessing the efficacy of a minimally invasive protocol in patients with bisphosphonate-associated osteonecrosis of the jaws. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2011 Dec;112(6):777-82. doi: 10.1016/j.tripleo.2011.07.004. Epub 2011 Oct 14.
- Background: PubMed 27475683Rodriguez-Lozano FJ, Onate-Sanchez RE. Treatment of osteonecrosis of the jaw related to bisphosphonates and other antiresorptive agents. Med Oral Patol Oral Cir Bucal. 2016 Sep 1;21(5):e595-600. doi: 10.4317/medoral.20980.
- Background: PubMed 24630868Carlson ER, Schlott BJ. Anti-resorptive osteonecrosis of the jaws: facts forgotten, questions answered, lessons learned. Oral Maxillofac Surg Clin North Am. 2014 May;26(2):171-91. doi: 10.1016/j.coms.2014.01.005. Epub 2014 Mar 13.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteonecrosis Due to Drugs, Jaw and Osteonecrosis of the Jaw, Bisphosphonate Related, run by Akdeniz University at 1 site in Turkey (Türkiye).
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 3 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 9 Apr 2025. 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 Turkey (Türkiye). 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?
Healing status of MRONJ lesions after medical vs surgical treatment (time frame: Treatment outcomes were assessed after 12 months.). 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 NCT06917846, which also lists 16 linked publications.
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 9 Apr 2025.