Mouth, Edentulous Clinical Trial
Official title:
Clinical Evaluation Protocol Post Market Follow Up Pavia CP009 SYNERGOSS PXX Observational
The device under investigation is SYNERGOSS, a CE (European Community CE) marked device.
Synergoss is a granulated bone graft intended for use in dental applications. It is composed
of a ceramic composite of Hydroxihapatite and Tricalciumphosphate in granules, coated with a
dedicated collagen coating (porcine origin), obtained by means of collagen crosslinking on
the ceramic granule surface.
The purpose of the study is to confirm the foreseen efficacy and tolerability of SYNERGOSS,
a synthetic dental graft coated with collagen. For this observational study, we will enroll
patients that already received a surgical intervention for sinus augmentation/ socket
preservation by means of SYNERGOSS to maintain and regenerate bone before installation of
endosseous titanium implants to support a fixed prosthesis. Patients will be enrolled just
before they receive the surgery for the installation of endosseous titanium implants, about
24 weeks after the first surgery for the implant of SYNERGOSS.
The primary hypothesis is to demonstrate that SYNERGOSS consistently obtains the foreseen
clinical benefit as declared in the Technical File.
The secondary hypothesis is to demonstrate that SYNERGOSS side effects and risks match those
declared in the Technical File.
The study design is a
- National
- Monocentric
- Prospective: the participants are identified and then followed forward in time.
- Observational: participants that have recently received the grafting with SYNERGIES as
part of normal and foreseen clinical procedures are enrolled in the study when they
receive surgery for titanium implant placement and observed over time, with no
substantial intervention other than the foreseen clinical treatment
n/a
Observational Model: Cohort, Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT02551146 -
Influence of Implants and Locators for Improved Retention
|
N/A | |
| Completed |
NCT03738189 -
Augmented Reality for Tooth Selection Augmented Reality for Tooth Selection
|
||
| Completed |
NCT00318487 -
Bilateral Sinus Floor Augmentation in Conjunction With Immediate Implant Loading - Study on 3i Dental Implants
|
N/A | |
| Withdrawn |
NCT03997604 -
A Descriptive, Prospective Clinical Study to Evaluate Full Dentures Fabricated by Additive Manufacturing
|
||
| Completed |
NCT02710357 -
A Cost-effectiveness Analysis of the Single-implant Mandibular Overdenture Treatment
|
N/A | |
| Recruiting |
NCT00172718 -
Using 3.3mm Screw Tap and Cutting Resistance to Evaluate Bone Quality Around Dental Implant
|
N/A | |
| Completed |
NCT03463174 -
Cost-effectiveness of the Single-implant Mandibular Overdenture Versus Mandibular Conventional Denture
|
N/A | |
| Active, not recruiting |
NCT05007691 -
Comparative Study of Maxillary and Mandibular Splints Used for the Treatment of Masticatory Muscle Parafunction (FEA)
|
N/A | |
| Withdrawn |
NCT02521935 -
Conventionally vs. Digitally Fabricated Complete Dentures: Clinical Treatment Outcome Differences
|
N/A | |
| Not yet recruiting |
NCT03391063 -
Evaluation of Chewing Efficiency of Conventional Complete Denture in Comparison to Reinforced Poly Amide Denture
|
N/A | |
| Not yet recruiting |
NCT05667389 -
Evaluation of the Vascular and Neural Elements Located in the Symphyseal Region Before Implant Surgery
|
||
| Terminated |
NCT04023006 -
An Observational Clinical Case Series Study to Assess Fit and Quality of Full Dentures Fabricated by AM
|
||
| Completed |
NCT01801566 -
Effectiveness of the Single Implant-retained Mandibular Overdenture Treatment
|
N/A | |
| Completed |
NCT01759537 -
Study to Evaluate Bone and Gum Dimension Changes Around Dental Implants Placed in Different Positions in Bone.
|
N/A |