Mouth, EdentulousNCT02775058
CP009 SYNERGOSS PXX Observational
An observational study of Mouth, Edentulous, run by Nobil Bio Ricerche srl at 1 site in Italy.
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)… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Mouth, Edentulous
- What is being tested?
- synergoss Pxx
- Type of treatment
- Medical device
- How many people
- 22 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2016to May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- • 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
Who cannot join
- • 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
marco morra, dr contact
Italy1 site, 1 recruiting
- Recruiting
Policlinico S. Matteo - Pavia
Pavia, PV, 27100
Ruggero Rodriguez y Baena, ruggero.rodriguez@unipv.it
About this study
Official title: Clinical Evaluation Protocol Post Market Follow Up Pavia CP009 SYNERGOSS PXX Observational
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.
Read more
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
- Being tested
- synergoss Pxx
- Medical subject headings
- Mouth, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
synergoss PxxDevice
dental grafting
| Study group | Role | What they receive |
|---|---|---|
| patients | 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. Receives: Device: synergoss Pxx |
What is being measured
The primary outcome is the main question the study is designed to answer.
• 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
Measured: 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
Measured: 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
Measured: 4-6 months
• device radiologic density (in a qualitative scale ranging from 1 to 4)
the radiological density is visually evaluated by the investigator
Measured: 4-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2016 (estimated)
- Study startJun 2016
- Primary completionMay 2017 (estimated)
- Study completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mouth, EdentulousStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nobil Bio Ricerche srl
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ruggero Rodriguez y Baena, Principal investigator, POLICLINICO S. MATTEO - PAVIA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02775058
- Sponsor's protocol ID
- CP009
- Status last verified
- Jun 2016
- First submitted
- 24 Mar 2016
- Last updated
- 29 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation Protocol Post Market Follow Up Pavia CP009 SYNERGOSS PXX Observational
- ClinicalTrials.gov ID
- NCT02775058
- Acronym / sponsor ID
- CP009
- Conditions
- Mouth, Edentulous
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Nobil Bio Ricerche srlIndustry (pharma, biotech, devices)
- Study start
- Jun 2016
- Primary completion
- May 2017 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 17 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients | – | Device: synergoss PxxThe 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- • Received in the past 16-24 weeks a bone graft for sinus lift or socket preservation with the ID
Key exclusion criteria (14 listed)
- • Uncontrolled Diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| synergoss Pxxdental grafting | Device | patients |
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
marco morra, dr contact
Ruggero Rodriguez y Baena principal investigator
POLICLINICO S. MATTEO - PAVIA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mouth, Edentulous, run by Nobil Bio Ricerche srl at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact marco morra, dr (mmorra@nobilbio.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Bone Volume total (%BV) (time frame: 4-6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2016.