CP009 SYNERGOSS PXX Observational

Mouth, Edentulous Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02775058
• Other study ID #: CP009
• Status: Recruiting
• Phase: N/A
• First received: March 24, 2016
• Last updated: June 28, 2016
• Start date: June 2016
• Est. completion date: May 2019

Study information

• Verified date: June 2016
• Source: Nobil Bio Ricerche srl
• Contact: marco morra, dr
• Email: mmorra[@]nobilbio.it
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 22
• Est. completion date: May 2019
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Mouth, Edentulous

Intervention

Device:
• synergoss Pxx
dental grafting

Locations

Country	Name	City	State
Italy	Policlinico S. Matteo - Pavia	Pavia	PV

Sponsors (1)

Lead Sponsor	Collaborator
Nobil Bio Ricerche srl

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• 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	No
Primary	• 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	No
Primary	• 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	No
Primary	• device radiologic density (in a qualitative scale ranging from 1 to 4)	the radiological density is visually evaluated by the investigator	4-6 months	No