NCT02775058

CP009 SYNERGOSS PXX Observational

Clinical Evaluation Protocol Post Market Follow Up Pavia CP009 SYNERGOSS PXX Observational

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 22 (estimated)
• Sponsor: Nobil Bio Ricerche srl · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Mouth, Edentulous

Interventions

Type	Name	Description
DEVICE	synergoss Pxx	dental grafting

Timeline

• Start date: 2016-06-01
• Primary completion: 2017-05-01
• Completion: 2019-05-01
• First posted: 2016-05-17
• Last updated: 2016-06-29

Locations

1 site across 1 country: Italy