Clinical trial NCT02775058: CP009 SYNERGOSS PXX Observational
Official title: Clinical Evaluation Protocol Post Market Follow Up Pavia CP009 SYNERGOSS PXX Observational
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mouth, Edentulous
Lead sponsor: Nobil Bio Ricerche srl
Sponsor class: INDUSTRY
First posted: 2016-05-17
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The subjects enrolled in this CI just received dental grafting and in any case will be subject to the same procedures foreseen for this CI for the dental implant surgery.

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 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


Eligibility criteria: 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

Primary outcomes:
measure: • Bone Volume total (%BV)
timeFrame: 4-6 months
measure: • graft Volume (%graft)
timeFrame: 4-6 months
measure: • vital bone (%VB).
timeFrame: 4-6 months
measure: • device radiologic density (in a qualitative scale ranging from 1 to 4)
timeFrame: 4-6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Policlinico S. Matteo - Pavia
state: PV
Study officials:
affiliation: POLICLINICO S. MATTEO - PAVIA
name: Ruggero Rodriguez y Baena
role: PRINCIPAL_INVESTIGATOR
References: