Registry for Mandibular Reconstruction After Oral Cancer or Osteonecrosis
This study is a registry collecting information from patients who need surgery to rebuild their jawbone (mandibular reconstruction). This surgery is needed after removing part of the jaw due to oral tumors like oral squamous cell carcinoma (OSCC), or jawbone damage from certain medications (drugs-induced osteonecrosis). The study will gather data on at least 300 patients, looking at details like your health history, nicotine use, and how well the reconstruction works. The goal is to understand the different ways jaw reconstruction is done and how they affect patient outcomes and quality of life.
- Study design
- This is an observational study, meaning researchers will collect information without giving you a specific treatment. It aims to include at least 300 patients.
- What's involved
- You would have data collected at baseline (before surgery) and then at 3, 6, 12, 18, and up to 24 months after your jaw surgery. This includes standard check-ups, patient surveys, and reviewing images of your jaw.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will be followed for up to 2 years after your jaw resection (removal of part of the jaw).
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Registry to Collect Data on Patients Undergoing Segmental Mandibular Defect Reconstruction Following Oral Squamous Cell Carcinoma Resection and Drugs-induced Osteonecrosis
At a glance
Conditions
Where it's being run
19 sites across 12 statesStudy leadership
- Rüdiger Zimmerer, PD, MD · PRINCIPAL_INVESTIGATOR · University of Leipzig
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Inclusion
Exclusion
What this trial measures
- DemographicsBaseline until resection surgery approximately 4 weeks
Demographics (year of birth, height in cm and weight in kilogram, race)
- ComorbiditiesBaseline 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 consumptionBaseline 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)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 cancerBaseline 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 systemBaseline 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 stagesDay 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 reconstructionDay 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 usedDay 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