CP009 SYNERGOSS PXX Observational

Study Overview
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Brief Summary
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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

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

Conditions
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Mouth, Edentulous

Intervention / Treatment
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* Device: synergoss Pxx


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Received in the past 16-24 weeks a bone graft for sinus lift or socket preservation with the ID Capable of giving a valid informed consent ASA 1, ASA 2 agrees to return for follow-up visits up to 2 years Exclusion Criteria: • Uncontrolled Diabetes Patients with psychiatric diseases Neoplasic, immunodepressive, renal or liver major illnesses Local radiotherapy Major bruxism or major differences in the maxilla or mandubilar area Drug or alcohol abuse Major bone metabolism disorders Heavy smokers (more than 10/day) bisphosphonate treatment of major ostheoporosys or bone neoplasia Pregnant women Sinus illnesses Contraindications to implant supported prostheses Patients ASA 3,ASA 4, ASA5 Surgical intervention contraindications

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients<br>The subjects enrolled in this CI just received dental grafting by the device under evaluation and in any case will be subject to the same procedures foreseen for this CI for the dental implant surgery. | Device: synergoss Pxx<br>* dental grafting<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • Bone Volume total (%BV) | 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 | 4-6 months | 
| • graft Volume (%graft) | 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 | 4-6 months | 
| • vital bone (%VB). | 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 | 4-6 months | 
| • device radiologic density (in a qualitative scale ranging from 1 to 4) | the radiological density is visually evaluated by the investigator | 4-6 months |