Immediate Reconstruction and Dental Rehabilitation of Maxillofacial Defects

NCT03369366 | Withdrawn

• 1 other identifier: IRB201702812
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Maxillofacial Injuries

Keywords

Maxillofacial Defects; Benign, large tumors requiring surgical resection

Outcome Measures

Primary Outcomes (1)

• Time to final dental rehabilitation

  Time elapsed until final dental rehabilitation is reached.

  6-8 months

Secondary Outcomes (4)

• Total operating room time

  6-8 hours

• Surgical outcome accuracy (CT imaging)

  5-10 days post-op

• Implant survival - Short term

  6 months post operatively

• Implant survival - Long term

  one year post operatively

Study Arms (1)

Reconstruction and Dental Rehabilitation

EXPERIMENTAL

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).

Device: NobelActive; Device: KLS Martin Mandibular Reconstruction Implant

Interventions

NobelActive DEVICE

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.

Reconstruction and Dental Rehabilitation

KLS Martin Mandibular Reconstruction Implant DEVICE

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).

Reconstruction and Dental Rehabilitation

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of Florida: lead

MeSH Terms

Conditions

Maxillofacial Injuries

Condition Hierarchy (Ancestors)

Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries

Study Officials

• Rui P Fernandes, MD, DMD

  Associate Professor; Associate Chair; Chief, Division of Head and Neck Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2017
• First Posted: December 12, 2017
• Study Start: July 1, 2019
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: July 17, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share