Mandibular ReconstructionNCT04098146
Registry to Collect Data on Patients Undergoing Segmental Mandibular Defect Reconstruction Following Oral Squamous Cell Carcinoma Resection and Drugs-induced Osteonecrosis
An observational study of Mandibular Reconstruction and Segmental Mandibular Defects, run by AO Innovation Translation Center at 19 sites in 8 countries.
Trial summary
Prospective will be collected in a minimum of 300 patients presenting with an acquired segmental mandibular defect ≥ 2 cm secondary to OSSC removal and drugs-induced osteonecrosis, and who require mandibular reconstruction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mandibular Reconstruction, Segmental Mandibular Defects
- What is being tested?
- Surgical Resection and Reconstruction
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 19 sitesin 8 countries
- Study dates
- 12 Sep 2022to 31 Dec 2030
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients presenting with an acquired segmental mandibular defect secondary to oral squamous cell carcinoma removal and who require mandibular reconstruction.
Who may be able to join
- The study includes patients with an initial pathological/histologic diagnosis of mandibular involvement by oral tumors (such as OSCC, osteosarcoma, and ameloblastoma), bisphosphonate- or immunomodulatory drug-induced osteonecrosis, and mandibular lesions from metastatic conditions originating from other sites including lung, breast, prostate, or kidney.
- Age 18 years and older
- Bisphosphonate related osteonecrosis of the mandible
- Immunomodulatory drugs induced mandibular osteonecrosis
- Patients presented with ameloblastoma affecting the mandible
- Patients presented with osteosarcomas of the mandible
Show all 13Show fewer
- Patients presented with oral metastases related mandibular lesions that are indicated for segmental resection, common primary tumor sites include lung, breast, prostate and kidney
- Undergoing primary curative treatment with segmental resection of the mandible ≥2 cm
- Intention to undergo mandibular reconstruction with autologous bone using a primary (one-stage) or secondary (two-stage) approach
- Informed consent obtained, ie:
- Ability to understand the content of the patient information/ICF
- Willingness and ability to participate in the clinical investigation according to the registry plan (RP) o Signed and dated IRB/EC approved ICF OR
- Written consent provided according to the IRB/EC defined and approved procedures for patients who are not able to provide to provide independent written informed consent
Who cannot join
- Tumors affecting the condyle
- Patients under palliative care
- Previous extensive mandibular surgeries (including reconstructions, e.g., TMJ replacement) that may potentially confound the outcome measures
- Intraoperative exclusion criteria:
- Nonsegmental mandibular defect (eg. box resection/partial resection)
- Segmental mandibular defect of less than 2 cm
Show all 9Show fewer
- Mandibular defects extending beyond the sigmoid notch into the condyles
- Additional exclusion criterion:
- No osseous reconstruction with autologous bone performed within 18 months from resection
Trial locations and contacts
19 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
Marco Minoia, PhD contact
19 sites in 8 countries
Germany8 sites, 8 recruiting
- Recruiting
University Hospital RWTH Aachen
Aachen, 52074
Ali Modabber, Prof, +49 241 80 88258, Amodabber@ukaachen.de
- Recruiting
University Hospital Charité
Berlin, 13353
Max Heiland, Prof, +49 450 655 270, Max.Heiland@charite.de
- Recruiting
Hannover Medical School
Hanover, 30625
Philippe Korn, PD, MD, +49 511 532 4879, korn.philippe@mh-hannover.de
- Recruiting
Universitätsklinikum Heidelberg
Heidelberg, 69120
Christian Freudlsperger, Prof, +49 6221 56 34444, Christian.Freudlsperger@med.uni-heidelberg.de
- Recruiting
University Hospital Leipzig
Leipzig, 04103
Tabea Pankow, PD, MD, + 49 3419721863, tabea.pankow@medizin.uni-leipzig.de
- Recruiting
Klinikum der LMU München
Munich, 80337
Wenko Smolka, PD, MD, +49 440054458, Wenko.Smolka@med.lmu.de
- Recruiting
Universitätsklinikum Tübingen
Tübingen, Baden-Wurttemberg, 72076
Andreas Naros, MD, +49 7071 2986174, andreas.naros@med.uni-tuebingen.de
- Recruiting
University Hospital Ulm
Ulm, 89081
Marcel Ebeling, +49 731 1710 35806, marcelebeling@uni-ulm.de
Marcel Ebeling
United States5 sites, 5 recruiting
- Recruiting
University of Illinois Chicago
Chicago, Illinois, 60612
Nicolas Callahan, MD, ncall@uic.edu
- Recruiting
John Peter Smith Health Network
Fort Worth, Texas, 76104
Roderick Kim, MD, +1 817-702-6979, roderickykim@gmail.com
- Recruiting
University of Florida College of Medicine
Jacksonville, Florida, 32209
Rui Fernandes, Prof, +1 904 244 3901, Rui.Fernandes@jax.ufl.edu
- Not yet recruiting
Northwell Health Cancer Institute
New Hyde Park, New York, 11042
Brett Miles, 6462846215, bmiles4@northwell.edu
Brett Miles
- Recruiting
Mount Sinai Hospital
New York, New York, 10029
Mohammed Khan, MD, mohemmed.khan@mountsinai.org
Japan1 site, 1 recruiting
- Not yet recruiting
Shimane University
Izumo, 693-0001
Takahiro Kanno, +81 90 5086 2506, tkanno@med.shimane-u.ac.jp
Takahiro Kanno
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus University Medical Centre
Rotterdam, 3015 GD
Eppo Wolvius, Prof, +31 6 22 48 77 81, E.Wolvius@erasmusmc.nl
Portugal1 site, 1 recruiting
- Not yet recruiting
Luz Hospital
Lisbon, 1500-650
Alberto Pereira, +351 917593318, alberto.rocha.pereira@hospitaldaluz.pt
Alberto Pereira
Spain1 site, 1 recruiting
- Recruiting
12 de Octubre
Madrid, 28041
Maria Mejía Nieto, MD, +34 687 083 530, Mmejianieto@hotmail.com
Sweden1 site, 1 recruiting
- Recruiting
Uppsala University Hospital
Uppsala, 75185
Andreas Thor, Prof, +46 18 6116450, Andreas.Thor@akademiska.se
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Basel
Basel, 4031
Florian Thieringer, MD, +41 612 657 344, Florian.Thieringer@usb.ch
About this study
Official title: A Prospective, International, Multicenter Registry of Patients Undergoing Segmental Mandibular Defects Reconstruction (SMDR) After Mandibular Resection for Tumors and Drugs-induced Osteonecrosis
Prospective will be collected in a minimum of 300 patients presenting with an acquired segmental mandibular defect ≥ 2 cm secondary to OSSC removal and drugs-induced osteonecrosis, and who require mandibular reconstruction.
Read the detailed description
Data will be prospectively collected from at least 300 patients with acquired segmental mandibular defects of 2 cm or larger following resection of tumors or necrotic/infected tissue, all of whom require mandibular reconstruction.
The follow up (FU) will consist of standard of care (routine) procedures and data collection will be done at 3, 6, 12, 18 and up to 24 months after resection and/or reconstruction. The maximum FU for each patient within the registry will be 2 years after mandibular resection.
Data collection will include confounding baseline data, tumor characteristics, neurological function, patient reported outcomes, quality of life as well as anticipated procedure-related adverse events (AEs). Available images will be collected and evaluated centrally to determine the location, positioning, osseointegration, bone quantity and quality of the transplants.
Depending on the volume and quality of the collected data, different statistical analyses will be performed. Exploratory analyses will be conducted to find relationships between the different treatment modalities and their outcomes.
- Being tested
- Surgical Resection and Reconstruction
- Keywords
- Mandibular osteotomy, Free bone flap, Reconstructive surgical procedure, Adjuvant Irradiation / Chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical Resection and ReconstructionProcedure or surgery
One stage reconstruction: Osseous reconstruction is performed in the same surgery of the tumor/mandibular resection. It is also known as immediate or primary reconstruction.
Second stage reconstruction: Osseous reconstruction is performed after the tumor/mandibular resection surgery as an independent surgery. After the mandibular resection a temporary alloplastic bridging might be put in place. It is also known as delayed or secondary reconstruction.
| Study group | Role | What they receive |
|---|---|---|
| Mandibular Reconstruction | Patients undergoing segmental mandibular defect reconstruction. The decision of one stage or two stage reconstruction is done according to the patient and treating surgeon preferences following the local standard of care Receives: Procedure: Surgical Resection and Reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographics
Demographics (year of birth, height in cm and weight in kilogram, race)
Measured: Baseline until resection surgery approximately 4 weeks
Comorbidities
Comorbidities assessed by Charlson Comorbidity Index (this score assesses the comorbidity level by considering both the number and severity of predefined comorbidity conditions. It provides a weighted score of a patient's comorbidities which can be used to predict mortality rates
Measured: Baseline until resection surgery approximately 4 weeks
Nicotine consumption
Current and previous nicotine use will be collected:
- Number of years
- Time (years) since stopped using (if applicable)
- Amount of cigarettes/day
Measured: Baseline until resection surgery approximately 4 weeks
Patient reported outcome: Oral Health Impact Profile (OHIP)
Change in the OHIP over the follow-up period.
The Oral Health Impact Profile is providing a comprehensive measure of self-reported dysfunction, discomfort and disability attributed to oral conditions. The OHIP is concerned with impairment and three functional status dimensions (social, psychological, and physical). Respondents are asked to indicate on a five-point Likert scale how frequently they experienced each problem. Response categories for the five-point scale are: "Very often", "Fairly often", "Occasionally", "Hardly ever" and "Never". The OHIP consists of 14 questions in which higher scores indicate worse outcomes.
Measured: Baseline/ 3months/ 6 months/ 12 months/ 18 months/ 24 months
Difference of tumor locations of the oral squamous cell cancer
Oral squamous cell carcinoma locations acoording to follwoing regions:
- Anterior compartment which includes lower lip, buccal mucosa, anterior vestibule, anterior ridge and anterior floor mouth
- Lateral compartment which includes posterior vestibule, posterior alveolar ridge, posterior (lateral) floor of mouth
- Retromolar compartment which includes alveolar ridge posterior to last molar, region of wisdom teeth, retromolar triangle ie buccal cheek, soft palate (arch), tonsillar regions
- Tongue which includes ventral tongue (undersurface of tongue), lateral rim of tongue, base of tongue
Measured: Baseline until resection surgery ( approximately 4 weeks)
Difference of tumor staging according to the TNM system
Oral squamous cell carcinoma staging according to TNM (Tumor, Node, Metastasis) system.
In the TNM system the "T" refers to the size and extent of the main tumor likert from T0 to T4 whereas T0 is the smallest and T4 the biggest size.
The main tumor is usually called the primary tumor. The "N" refers to the number of nearby lymph nodes that have cancer likert for N0 to N3 whereas N0 is the single nearby lymphnode and N3 multiple lymphnodes. The "M" refers to whether the cancer has metastasized likert from M0 to M1 whereas M0 is no distant metastasis and M1 is distant metastasis.
Measured: Baseline until resection surgery ( approximately 4 weeks)
Difference of surgical duration and hospital stay if resection and reconstruction was performed in one or two stages
- Duration of surgery (skin to skin) in minutes
- Length of hospital stay in days
- Date of osseous reconstruction (if different from resection surgery) in days
Measured: Day of resection surgery until day of reconstruction surgery up to 18 months
Difference of surgical procedures of osseous reconstruction
- Numers of Bone and soft tissue flaps to reconstruct the mandible: ie number of pieces in which the donor bone(s) is cut to shape the reconstructed mandible
- Type of bone donor/ bone transfer site(s): Vascularized bone flap(s) or composite flaps (ie bone and adjacent soft tissue harvested within the same flap) and type(s)
Measured: Day of resection surgery until day of reconstruction surgery up to 18 months
Different surgical parameters of tumor and segmental mandibular resection if VSP planning was used
- Use of virtual surgical planning (VSP) for resection: Yes/No.
- Only virtual planning and simulation of resection (no 3D printing):Yes/No.
- 3D-printed biomodels: Yes/No
Measured: Day of resection surgery until day of reconstruction surgery up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2019
- Study start12 Sep 2022
- Primary completion30 Jun 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mandibular ReconstructionStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- AO Innovation Translation Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rüdiger Zimmerer, PD, MD, Principal investigator, University of Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04098146
- Sponsor's protocol ID
- SMDR Registry
- Status last verified
- Aug 2025
- First submitted
- 13 Sep 2019
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, International, Multicenter Registry of Patients Undergoing Segmental Mandibular Defects Reconstruction (SMDR) After Mandibular Resection for Tumors and Drugs-induced Osteonecrosis
- ClinicalTrials.gov ID
- NCT04098146
- Acronym / sponsor ID
- SMDR Registry
- Keywords
- Mandibular osteotomy, Free bone flap, Reconstructive surgical procedure, Adjuvant Irradiation / Chemotherapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- AO Innovation Translation CenterUniversity, hospital or other
- Study start
- 12 Sep 2022 (actual)
- Primary completion
- 30 Jun 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 23 Sep 2019 (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.
Prospective will be collected in a minimum of 300 patients presenting with an acquired segmental mandibular defect ≥ 2 cm secondary to OSSC removal and drugs-induced osteonecrosis, and who require mandibular reconstruction.
Detailed description
Data will be prospectively collected from at least 300 patients with acquired segmental mandibular defects of 2 cm or larger following resection of tumors or necrotic/infected tissue, all of whom require mandibular reconstruction.
The follow up (FU) will consist of standard of care (routine) procedures and data collection will be done at 3, 6, 12, 18 and up to 24 months after resection and/or reconstruction. The maximum FU for each patient within the registry will be 2 years after mandibular resection.
Data collection will include confounding baseline data, tumor characteristics, neurological function, patient reported outcomes, quality of life as well as anticipated procedure-related adverse events (AEs). Available images will be collected and evaluated centrally to determine the location, positioning, osseointegration, bone quantity and quality of the transplants.
Depending on the volume and quality of the collected data, different statistical analyses will be performed. Exploratory analyses will be conducted to find relationships between the different treatment modalities and their outcomes.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mandibular Reconstruction | – | Procedure: Surgical Resection and ReconstructionPatients undergoing segmental mandibular defect reconstruction. The decision of one stage or two stage reconstruction is done according to the patient and treating surgeon preferences following the local standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients presenting with an acquired segmental mandibular defect secondary to oral squamous cell carcinoma removal and who require mandibular reconstruction.
Key inclusion criteria (13 listed)
- The study includes patients with an initial pathological/histologic diagnosis of mandibular involvement by oral tumors (such as OSCC, osteosarcoma, and ameloblastoma), bisphosphonate- or immunomodulatory drug-induced osteonecrosis, and mandibular lesions from metastatic conditions originating from other sites including lung, breast, prostate, or kidney.
- Age 18 years and older
- Bisphosphonate related osteonecrosis of the mandible
- Immunomodulatory drugs induced mandibular osteonecrosis
- Patients presented with ameloblastoma affecting the mandible
Key exclusion criteria (9 listed)
- Tumors affecting the condyle
- Patients under palliative care
- Previous extensive mandibular surgeries (including reconstructions, e.g., TMJ replacement) that may potentially confound the outcome measures
- Nonsegmental mandibular defect (eg. box resection/partial resection)
- Segmental mandibular defect of less than 2 cm
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 Resection and ReconstructionOne stage reconstruction: Osseous reconstruction is performed in the same surgery of the tumor/mandibular resection. It is also known as immediate or primary reconstruction. Second stage reconstruction: Osseous reconstruction is performed after the tumor/mandibular resection surgery as an independent surgery. After the mandibular resection a temporary alloplastic bridging might be put in place. It is also known as delayed or secondary reconstruction. | Procedure or surgery | Mandibular Reconstruction |
Primary outcome
Demographics
Time frame: Baseline until resection surgery approximately 4 weeks
Demographics (year of birth, height in cm and weight in kilogram, race)
Comorbidities
Time frame: Baseline until resection surgery approximately 4 weeks
Comorbidities assessed by Charlson Comorbidity Index (this score assesses the comorbidity level by considering both the number and severity of predefined comorbidity conditions. It provides a weighted score of a patient's comorbidities which can be used to predict mortality rates
Nicotine consumption
Time frame: Baseline until resection surgery approximately 4 weeks
Current and previous nicotine use will be collected: * Number of years * Time (years) since stopped using (if applicable) * Amount of cigarettes/day
Patient reported outcome: Oral Health Impact Profile (OHIP)
Time frame: Baseline/ 3months/ 6 months/ 12 months/ 18 months/ 24 months
Change in the OHIP over the follow-up period. The Oral Health Impact Profile is providing a comprehensive measure of self-reported dysfunction, discomfort and disability attributed to oral conditions. The OHIP is concerned with impairment and three functional status dimensions (social, psychological, and physical). Respondents are asked to indicate on a five-point Likert scale how frequently they experienced each problem. Response categories for the five-point scale are: "Very often", "Fairly often", "Occasionally", "Hardly ever" and "Never". The OHIP consists of 14 questions in which higher scores indicate worse outcomes.
Difference of tumor locations of the oral squamous cell cancer
Time frame: Baseline until resection surgery ( approximately 4 weeks)
Oral squamous cell carcinoma locations acoording to follwoing regions: * Anterior compartment which includes lower lip, buccal mucosa, anterior vestibule, anterior ridge and anterior floor mouth * Lateral compartment which includes posterior vestibule, posterior alveolar ridge, posterior (lateral) floor of mouth * Retromolar compartment which includes alveolar ridge posterior to last molar, region of wisdom teeth, retromolar triangle ie buccal cheek, soft palate (arch), tonsillar regions * Tongue which includes ventral tongue (undersurface of tongue), lateral rim of tongue, base of tongue
Difference of tumor staging according to the TNM system
Time frame: Baseline until resection surgery ( approximately 4 weeks)
Oral squamous cell carcinoma staging according to TNM (Tumor, Node, Metastasis) system. In the TNM system the "T" refers to the size and extent of the main tumor likert from T0 to T4 whereas T0 is the smallest and T4 the biggest size. The main tumor is usually called the primary tumor. The "N" refers to the number of nearby lymph nodes that have cancer likert for N0 to N3 whereas N0 is the single nearby lymphnode and N3 multiple lymphnodes. The "M" refers to whether the cancer has metastasized likert from M0 to M1 whereas M0 is no distant metastasis and M1 is distant metastasis.
Difference of surgical duration and hospital stay if resection and reconstruction was performed in one or two stages
Time frame: Day of resection surgery until day of reconstruction surgery up to 18 months
* Duration of surgery (skin to skin) in minutes * Length of hospital stay in days * Date of osseous reconstruction (if different from resection surgery) in days
Difference of surgical procedures of osseous reconstruction
Time frame: Day of resection surgery until day of reconstruction surgery up to 18 months
* Numers of Bone and soft tissue flaps to reconstruct the mandible: ie number of pieces in which the donor bone(s) is cut to shape the reconstructed mandible * Type of bone donor/ bone transfer site(s): Vascularized bone flap(s) or composite flaps (ie bone and adjacent soft tissue harvested within the same flap) and type(s)
Different surgical parameters of tumor and segmental mandibular resection if VSP planning was used
Time frame: Day of resection surgery until day of reconstruction surgery up to 18 months
* Use of virtual surgical planning (VSP) for resection: Yes/No. * Only virtual planning and simulation of resection (no 3D printing):Yes/No. * 3D-printed biomodels: Yes/No
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 4 Sep 2025.
- 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.
Marco Minoia, PhD contact
Rüdiger Zimmerer, PD, MD principal investigator
University of Leipzig
19 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mandibular Reconstruction and Segmental Mandibular Defects, run by AO Innovation Translation Center at 19 sites in 8 countries.
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 13 inclusion and 9 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 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Germany, United States, Japan, Netherlands, Portugal and 3 more countries. 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 Maria Medina Giner (0795456120, maria.medinaginer@aofoundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographics (time frame: Baseline until resection surgery approximately 4 weeks). The study lists 9 primary outcomes in all. 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 4 Sep 2025.