Health Condition 1: C00-D49- Neoplasms
Conditions
Interventions
Intervention1: NANOTEX BONE GRAFT: NANOTEX BONE graft in combination with fibula flap for bone augmentation. NANOTEX is biomimetic, osteoconductive, porous, mechanically stable and biodegradable in na
Sponsors
Amrita Vishwa Vidyapeetham Amrita Institute of Medical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients must be 18 to 65 years of age inclusive, at the time of signing the informed consent. 2.Segmental Mandibular defect due to resection of benign tumour or trauma 3.A female patient is eligible to participate if she is not pregnant, not breastfeeding 4.Patient must be available at the study centre for all specified assessments throughout the study duration. 5.Patients whose clinical laboratory test results are within the reference range for healthy individuals, or where outside the reference range is judged as not clinically relevant by the Investigator
Exclusion criteria
Exclusion criteria: -Uncontrolled alcohol, tobacco, or substance abuse within 6 months prior to implantation. -Mandibular ramus defects with open wounds. -Systemic disease that would affect the surgical procedure and implant integration along with associated anesthesia, unsafe to the patient. -Patient has any underlying or current medical or psychiatric condition that, in the opinion of the Investigator, would impact patient safety or interfere with the integrity of the study data -Active uncontrolled infection or malignancy. -Patients indicated for radiotherapy before and after surgery -Patients participated in any other clinical trial in past 1 month, or currently participating in any other clinical trial. -Conditions that may impact the success of the surgical implantation or increase the risk of postoperative complications, including inherited coagulopathies like hemophilia, Von Wille brand s disease, protein C and S deficiency, thrombocythemias, thallassemias, sickle cell disease, etc. -Conditions that may impact functional outcomes, including uncontrolled diabetes, osteoporosis, rare disorders of bone healing like osteopetrosis, or any other metabolic bone disease. -Increased alkaline phosphatase (to exclude Paget s disease), increased serum calcium (to exclude hyperparathyroidism), or Vitamin D deficiency, at Screening, confirmed by a repeat test. -Oral bisphosphonate -Mixed connective tissue diseases and collagen diseases which can result in poor wound healing after surgery. -Patients participated in any other clinical trial in past 1 month, or currently participating in any other clinical trial. .
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety of the NANOTEX BONE Graft in combination with fibula flap for bone augmentationTimepoint: Day 8, 1 month, 3 months, 6 months, 9 months, 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of the NANOTEX BONE Graft in combination with fibula flap to regenerate new bone in aiding Titanium dental implant placement and integration.Timepoint: Day 8, 1 month, 3 months, 6 months, 9 months, 12 months | — |
Countries
India
Contacts
Public ContactDr Subramania Iyer
Amrita School of Nanosciences & molecular medicine
Outcome results
None listed