Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05526547 |
| Other study ID # |
cantilever |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2018 |
| Est. completion date |
June 30, 2022 |
Study information
| Verified date |
April 2023 |
| Source |
D'Albis Dental |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Fifteen partially edentulous patients received 34 implants and were provided 16 zirconia
fixed partial prostheses (FPPs) with one cantilever extension replacing mandibular or
maxillary missing posterior and lateral teeth. Patients were re-examined up to 4 years.
Description:
The investigators consecutively enrolled 15 patients who required dental implant
rehabilitation with fixed dental prosthesis. All patients were attended at a private
out-patient clinic from 2018 to 2021.The study was conducted in Italy and all procedures
respect European laws and regulations.A diagnostic wax-up of the missing teeth was performed
on digital casts for each case. Each case was designed using software planning the implant
position in the distal part of the edentulous ridge where the bone conditions were more
favorable.The surgical procedures were performed according to the protocols given by
manufacturers.The implant site was prepared after raising a full-thickness flap. The implant
was placed as designed in the digital planning with the support of a surgical guide.The
patients were recalled 3-6 months after surgery for a pre-prosthetic evaluation. A healing
abutment was placed, and implant stability was proven.Three weeks after second-stage surgery,
the definitive digital impression was taken using an intraoral scanner. The prosthetic
procedures were performed according to manufacturers' implant system recommendations. All
prostheses were designed using CAD software with a connector cross-sectional area of at least
12 mm2. Monolithic zirconia fixed partial dentures were fabricated using a CAD-CAM unit from
pre-sintered, pre-shade zirconia blanks . The fixed dentures were characterized with
ceramic-based colors. The screw-retained zirconia prosthesis were subsequently inserted, and
a check of the occlusion was performed.The patients get a baseline examination after 1-3
weeks of final prosthesis insertion. Aesthetics, proximal contacts, and occlusion were
modified when needed following a careful examination. Patients were recalled at least once a
year to assess the restorations functionally and aesthetically, peri-implant tissues, and
implant health status. An individual maintenance program with regular dental hygiene sessions
was performed during the entire study period for every patient, and an x-ray was taken at the
2-year follow-up.
