Maxillofacial Injuries Clinical Trial
Official title:
Immediate Reconstruction and Dental Rehabilitation of Maxillofacial Defects
NCT number | NCT03369366 |
Other study ID # | IRB201702812 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | July 2019 |
Est. completion date | June 2021 |
Verified date | July 2019 |
Source | University of Florida |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Immediate reconstruction and dental rehabilitation of maxillofacial ablative defects with patient specific reconstruction plates, dental implants, and immediate load provisional screw-retained prosthesis will improve patient short and long term outcomes and improve patient quality of life. Utilizing current technologic advances, patients undergoing large ablative procedures for benign head and neck pathology can now not only have immediate bone and soft tissue reconstruction, but dental rehabilitation as well. Using virtual surgical planning, patient specific selective laser melded reconstruction plates, and dental implants, a screw-retained provisional dental restoration can be fabricated and placed during a one-stage procedure with minimal to no intra-operative prosthetic work required.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | June 2021 |
Est. primary completion date | June 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years to 60 Years |
Eligibility |
Inclusion and Exclusion Criteria Inclusion Criteria: - Male and Female patients between 16 and 60 years of age - Patients with benign, large tumors requiring surgical resection with free tissue transfer reconstruction involving the maxilla and mandible will be included in the study. Exclusion Criteria: - Patients below the age of 16 years and over the age of 60 years - Patients with malignant tumors - Patients with contraindications for surgical intervention and/or free tissue transfer - Patients actively participating in another investigational clinical study and who, in the Investigator's or opinion, should not be enrolled in this study. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Florida |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to final dental rehabilitation | Time elapsed until final dental rehabilitation is reached. | 6-8 months | |
Secondary | Total operating room time | The total time taken in operating room for a procedure | 6-8 hours | |
Secondary | Surgical outcome accuracy (CT imaging) | Accuracy of the proposed surgical outcome assessed via CT scan imaging | 5-10 days post-op | |
Secondary | Implant survival - Short term | Six month survival rate of the dental implant | 6 months post operatively | |
Secondary | Implant survival - Long term | Long term survival rate of the dental implant | one year post operatively |
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