Clinical trial · Interventional
Immediate Reconstruction and Dental Rehabilitation of Maxillofacial Defects
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Funding not received.
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Maxillofacial Injuries | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| KLS Martin Mandibular Reconstruction Implant | Device | — | UNRESOLVED |
| NobelActive | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Reconstruction and Dental Rehabilitation
- description
- 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).
- interventionNames
- Device: NobelActive
- Device: KLS Martin Mandibular Reconstruction Implant
Primary outcomes (1)
- measure
- Time to final dental rehabilitation
- timeFrame
- 6-8 months
- description
- Time elapsed until final dental rehabilitation is reached.
Secondary outcomes (4)
- measure
- Total operating room time
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available