Immediate Reconstruction and Dental Rehabilitation of Maxillofacial Defects
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|ClinicalTrials.gov Identifier: NCT03369366|
Recruitment Status : Not yet recruiting
First Posted : December 12, 2017
Last Update Posted : June 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Maxillofacial Injuries||Device: NobelActive Device: KLS Martin Mandibular Reconstruction Implant||Not Applicable|
The primary goal of any reconstructive procedure is to restore a patient's natural form and function. The new techniques implemented in this study will demonstrate an approach that allows immediate return of the patient's premorbid state in one procedure. The investigators have demonstrated success with a small cohort of patients, and published a recent case study regarding this new technique. This study is meant to build upon the investigators experiences and advance their process and treatment of these patients. With a larger patient population to study, greater data can be obtained, with the ultimate goal of establishing this treatment as a new standard of care for patients with large ablative defects requiring reconstruction.
Patients with benign, large tumors requiring surgical resection with free tissue transfer reconstruction involving the maxilla and mandible will be included in the study. All of the patients will undergo the following pre-operative protocol:
- CT Maxillofacial Region
- Dental impression (intra-oral scan and/or impressions)
- Virtual surgical planning
- Patient specific plate fabrication
- Resection and flap harvest osteotomy guides
- Fabrication of screw-retained provisional prosthesis
Surgical treatment protocol involves:
- Resection of benign tumor using osteotomy guides
- Reconstruction with free tissue (osseous free flap) transfer using osteotomy guides
- Placement of dental implants (minimum of three) using integrated osteotomy and implant placement guide
- Placement of provisional screw-retained prosthesis (all while flap is still pedicled to vascular supply)
- Inset of flap/implant/prosthesis/custom plate construct
- Vascular anastomosis and closure
Immediate post-operative management will include a 5-to-7 day post-operative hospital stay and a post-operative CT scan evaluation. Long-term evaluation of patients will include routine clinical exams and cone beam CT scans to evaluate flap and implant survival. Patients, for the purpose of this study, will be followed for one year following placement of final dental prosthesis (18-24 months post-operatively).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Immediate Reconstruction and Dental Rehabilitation of Maxillofacial Defects|
|Estimated Study Start Date :||August 15, 2018|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||June 2021|
Experimental: Reconstruction and Dental Rehabilitation
Placement of NobelActive dental implants (minimum of three) using integrated osteotomy and implant placement guide.Placement of provisional screw-retained prosthesis (all while flap is still pedicled to vascular supply). Inset of flap/implant/prosthesis/custom plate construct (KLS Martin Mandibular Reconstruction Implant).
NobelActive's expanding tapered implant body condenses bone gradually while the apex with drilling blades enables a smaller osteotomy. These features help to achieve high primary stability in demanding situations, such as soft bone or extraction sockets. NobelActive enables immediate implant placement and Immediate Function where it might otherwise be challenging.
Device: KLS Martin Mandibular Reconstruction Implant
The prefabricated prosthesis will be secured onto the implants using non-engaging multiunit abutments with screws, followed by fixation of the patient-specific plate to the fibula with monocortical screws. The previously used cutting guides are fixated with the screw locations corresponding to the screw locations of the custom plate. This allows for accurate positioning and fixation of the custom construct of the plate and fibula without the need for intermaxillary fixation (IMF).
- Time to final dental rehabilitation [ Time Frame: 6-8 months ]Time elapsed until final dental rehabilitation is reached.
- Total operating room time [ Time Frame: 6-8 hours ]The total time taken in operating room for a procedure
- Surgical outcome accuracy (CT imaging) [ Time Frame: 5-10 days post-op ]Accuracy of the proposed surgical outcome assessed via CT scan imaging
- Implant survival - Short term [ Time Frame: 6 months post operatively ]Six month survival rate of the dental implant
- Implant survival - Long term [ Time Frame: one year post operatively ]Long term survival rate of the dental implant
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03369366
|Contact: Rui P Fernandes, MD, DMDfirstname.lastname@example.org|
|Contact: Salam O Salman, MD, DDSemail@example.com|
|Principal Investigator:||Rui P Fernandes, MD, DMD||Associate Professor; Associate Chair; Chief, Division of Head and Neck Surgery|