Clinical Trial: CP009 SYNERGOSS PXX Observational

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

Brief 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 pr

    Detailed Summary:
    Sponsor: Nobil Bio Ricerche srl

    Current Primary Outcome:

    • • Bone Volume total (%BV) [ Time Frame: 4-6 months ]
      The specimen, extracted from the bone of the patient, will be evaluated to define the quantity of total bone volume as compared to the specimen volume
    • • graft Volume (%graft) [ Time Frame: 4-6 months ]
      The specimen, extracted from the bone of the patient, will be evaluated to define the quantity of residual, non absorbed graft volume as compared to the specimen volume
    • • vital bone (%VB). [ Time Frame: 4-6 months ]
      The specimen, extracted from the bone of the patient, will be evaluated to define the quantity of vital, new formed bone volume as compared to the specimen volume
    • • device radiologic density (in a qualitative scale ranging from 1 to 4) [ Time Frame: 4-6 months ]
      the radiological density is visually evaluated by the investigator


    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: Nobil Bio Ricerche srl

    Dates:
    Date Received: March 24, 2016
    Date Started: June 2016
    Date Completion: May 2019
    Last Updated: June 28, 2016
    Last Verified: June 2016