Alveolar Bone LossSYNBIONCT03077867
Comparison Synthetic Hydroxyapatite and Inorganic Bovine Bone in Sinus Floor Elevation
A study testing sinus floor augmentation with bone graft in people with Alveolar Bone Loss, run by International Piezosurgery Academy at 1 site in Italy.
Trial summary
This is set as prospective clinical trial to correlate histologically and radiologically the performance of four different bone grafts (synthetic hydroxyapatite alone, synthetic hydroxyapatite mixed with polylactic-polyglycolic acid, synthetic hydroxyapatite with i-PRF and inorganic bone graft) in the sinus floor… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alveolar Bone Loss
- What is being tested?
- sinus floor augmentation with bone graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteItaly
- Study dates
- 15 Jan 2017to 15 Mar 2021
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- indications for intervention of sinus lift with lateral approach to allow the insertion of dental implants, based on careful diagnosis and treatment plan;
- presence of residual bone crest with a height ≤3 mm on the maxillary sinus, at the level of the implant sites planned;
- the bone crest must be intact (at least 3 months after the loss / extraction of the element corresponding tooth);
- 5) patients must be able to examine and understand the study protocol; 6) informed consent.
Who cannot join
- acute myocardial infarction within the last six months;
- uncontrolled bleeding disorders;
- uncontrolled diabetes (HBA1c> 7.5%);
- radiation therapy in the district head / neck in the last 24 months;
- immunocompromised (e.g. HIV infection or chemotherapy in the last three years);
- current or past treatment with intravenous bisphosphonates;
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- allergy to bovine collagen;
- psychological or psychiatric diseases;
- abuse of alcohol or drug use;
- not controlled periodontal disease;
- sinus disorders that contraindicate the maxillary sinus lift
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Histological and Radiographic Evidence After Sinus Lift With Synthetic Nano-hydroxyapatite and Inorganic Bovine Bone.
This is set as prospective clinical trial to correlate histologically and radiologically the performance of four different bone grafts (synthetic hydroxyapatite alone, synthetic hydroxyapatite mixed with polylactic-polyglycolic acid, synthetic hydroxyapatite with i-PRF and inorganic bone graft) in the sinus floor elevation technique with lateral approach for the treatment of atrophic crests.
Read the detailed description
SURGICAL PROCEDURE:
After local anesthesia and a large full-thickness mucoperiosteal flap in the area of interest, an osteotomy window on the side wall of the maxillary sinus will be opened using bone scrapers and / or ultrasonic instruments. Will be recorded the time needed for the opening dell'antrostomy and any perforations of the membrane at this stage. The Schneider membrane is then gently elevated with ultrasonic instrumentation and curettes manuals: after testing the integrity of the membrane by means of visual inspection and the Valsalva maneuver, the sealed envelope in which will be indicated to the surgeon the material to be used as a graft will be opened. The biomaterials selected for this study are a synthetic nano-hydroxyapatite (SNHA) (FISIOGRAFT Bone, Italy), to be used either alone, or mixed with a polylactic- polyglycolic copolymer (PLGA) (FISIOGRAFT, Italy), or mixed with autologous platelet derived (i-PRF) and inorganic bovine bone (ABB) (Bio-Oss, Geistlich, Switzerland). After completing the insertion of the biomaterial, the antrostomy will be protected with a resorbable collagen membrane (BioGide, Geistlich, Switzerland) and the flaps will be sutured with a synthetic monofilament.
It will prescribe antibiotics for 6 days (amoxicillin 1 g twice daily or, in allergic patients, clarithromycin 250 mg twice a day) and NSAIDs (ibuprofen 600 mg), as needed. An aerosol treatment with beclomethasone dipropionate and n-acetylcysteine (Fluimucil, Zambon, Italy) will be prescribed at the discretion of the clinician.
POSTOPERATIVE RECALLS:
The sutures will be removed after 10 days and a cone beam computed tomography X-ray will be performed to assess the correct distribution of the graft material and early intercept any accidental leakage of the same in the sinus cavities.
After six months it will proceed to a new radiographic evaluation to assess the resulting regeneration and be able to plan the implant placement.
It will then proceed to the preparation of the sites for the implants using twist-drills. The fixtures are left healed submerged for a period of four months, at the end of which will be connected with the healing screws to start the prosthetic procedures.
After therapy patients will enter a maintenance program with periodic reminders of professional oral hygiene. Patients will be re-evaluated clinically and radiologically after one, three and five years to control the condition of the plants and the stability of the performed regeneration.
- Conditions
- Alveolar Bone Loss
- Being tested
- sinus floor augmentation with bone graft
- Keywords
- sinus lift, synthetic hydroxyapatite, bone graft
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sinus floor augmentation with bone graftProcedure or surgery
Also called LASFE
sinus floor augmentation with lateral approach with bone graft
| Study group | Role | What they receive |
|---|---|---|
| test HA | Experimental | synthetic hydroxyapatite alone sinus floor augmentation with bone graft Receives: Procedure: sinus floor augmentation with bone graft |
| test HA vicryl | Experimental | synthetic hydroxyapatite mixed with polylactic-polyglycolic acid sinus floor augmentation with bone graft Receives: Procedure: sinus floor augmentation with bone graft |
| test HA-PRF | Experimental | synthetic hydroxyapatite mixed with i-PRF sinus floor augmentation with bone graft Receives: Procedure: sinus floor augmentation with bone graft |
| control | Active comparator | anorganic bovine bone sinus floor augmentation with bone graft Receives: Procedure: sinus floor augmentation with bone graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison of histological performance of the bone grafts
histomorphometric analysis
Measured: 6 months after surgery
Secondary outcomes (2)
implant success
clinical and radiological success of implants inserted in augmented sites
Measured: 6 months after surgery
comparison of radiological evidence of the bone grafts
cone beam computed tomography scans of the augmented sinuses
Measured: before surgery and 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2017
- Study start15 Jan 2017
- Primary completion15 Mar 2020
- Study completion15 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alveolar Bone LossStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Piezosurgery Academy
- Sponsor type
- University, hospital or other
- Collaborators
- University of Trieste
- Responsible party
- Principal investigator, Mr. Claudio Stacchi, DDS, MSc, International Piezosurgery Academy
- Investigators
- Claudio Stacchi, Dr., Study director, Piezosurgery Academy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03077867
- Sponsor's protocol ID
- SINBYO
- Acronym
- SYNBIO
- Status last verified
- Mar 2021
- First submitted
- 25 Jan 2017
- Last updated
- 26 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Farina R, Pramstraller M, Franceschetti G, Pramstraller C, Trombelli L. Alveolar ridge dimensions in maxillary posterior sextants: a retrospective comparative study of dentate and edentulous sites using computerized tomography data. Clin Oral Implants Res. 2011 Oct;22(10):1138-1144. doi: 10.1111/j.1600-0501.2010.02087.x. Epub 2011 Feb 15.
PubMed 21320169Del Fabbro M, Testori T, Francetti L, Weinstein R. Systematic review of survival rates for implants placed in the grafted maxillary sinus. Int J Periodontics Restorative Dent. 2004 Dec;24(6):565-77.
PubMed 15626319
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Histological and Radiographic Evidence After Sinus Lift With Synthetic Nano-hydroxyapatite and Inorganic Bovine Bone.
- ClinicalTrials.gov ID
- NCT03077867
- Acronym / sponsor ID
- SYNBIO / SINBYO
- Conditions
- Alveolar Bone Loss
- Keywords
- sinus lift, synthetic hydroxyapatite, bone graft
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- International Piezosurgery AcademyUniversity, hospital or other
- Collaborators
- University of Trieste
- Study start
- 15 Jan 2017 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 15 Mar 2021 (actual)
- First posted
- 13 Mar 2017 (actual)
- 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.
This is set as prospective clinical trial to correlate histologically and radiologically the performance of four different bone grafts (synthetic hydroxyapatite alone, synthetic hydroxyapatite mixed with polylactic-polyglycolic acid, synthetic hydroxyapatite with i-PRF and inorganic bone graft) in the sinus floor elevation technique with lateral approach for the treatment of atrophic crests.
Detailed description
SURGICAL PROCEDURE:
After local anesthesia and a large full-thickness mucoperiosteal flap in the area of interest, an osteotomy window on the side wall of the maxillary sinus will be opened using bone scrapers and / or ultrasonic instruments. Will be recorded the time needed for the opening dell'antrostomy and any perforations of the membrane at this stage. The Schneider membrane is then gently elevated with ultrasonic instrumentation and curettes manuals: after testing the integrity of the membrane by means of visual inspection and the Valsalva maneuver, the sealed envelope in which will be indicated to the surgeon the material to be used as a graft will be opened. The biomaterials selected for this study are a synthetic nano-hydroxyapatite (SNHA) (FISIOGRAFT Bone, Italy), to be used either alone, or mixed with a polylactic- polyglycolic copolymer (PLGA) (FISIOGRAFT, Italy), or mixed with autologous platelet derived (i-PRF) and inorganic bovine bone (ABB) (Bio-Oss, Geistlich, Switzerland). After completing the insertion of the biomaterial, the antrostomy will be protected with a resorbable collagen membrane (BioGide, Geistlich, Switzerland) and the flaps will be sutured with a synthetic monofilament.
It will prescribe antibiotics for 6 days (amoxicillin 1 g twice daily or, in allergic patients, clarithromycin 250 mg twice a day) and NSAIDs (ibuprofen 600 mg), as needed. An aerosol treatment with beclomethasone dipropionate and n-acetylcysteine (Fluimucil, Zambon, Italy) will be prescribed at the discretion of the clinician.
POSTOPERATIVE RECALLS:
The sutures will be removed after 10 days and a cone beam computed tomography X-ray will be performed to assess the correct distribution of the graft material and early intercept any accidental leakage of the same in the sinus cavities.
After six months it will proceed to a new radiographic evaluation to assess the resulting regeneration and be able to plan the implant placement.
It will then proceed to the preparation of the sites for the implants using twist-drills. The fixtures are left healed submerged for a period of four months, at the end of which will be connected with the healing screws to start the prosthetic procedures.
After therapy patients will enter a maintenance program with periodic reminders of professional oral hygiene. Patients will be re-evaluated clinically and radiologically after one, three and five years to control the condition of the plants and the stability of the performed regeneration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| test HA | Experimental | Procedure: sinus floor augmentation with bone graftsynthetic hydroxyapatite alone sinus floor augmentation with bone graft |
| test HA vicryl | Experimental | Procedure: sinus floor augmentation with bone graftsynthetic hydroxyapatite mixed with polylactic-polyglycolic acid sinus floor augmentation with bone graft |
| test HA-PRF | Experimental | Procedure: sinus floor augmentation with bone graftsynthetic hydroxyapatite mixed with i-PRF sinus floor augmentation with bone graft |
| control | Active comparator | Procedure: sinus floor augmentation with bone graftanorganic bovine bone sinus floor augmentation with bone graft |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- indications for intervention of sinus lift with lateral approach to allow the insertion of dental implants, based on careful diagnosis and treatment plan;
- presence of residual bone crest with a height ≤3 mm on the maxillary sinus, at the level of the implant sites planned;
- the bone crest must be intact (at least 3 months after the loss / extraction of the element corresponding tooth);
- 5) patients must be able to examine and understand the study protocol; 6) informed consent.
Key exclusion criteria (11 listed)
- acute myocardial infarction within the last six months;
- uncontrolled bleeding disorders;
- uncontrolled diabetes (HBA1c> 7.5%);
- radiation therapy in the district head / neck in the last 24 months;
- immunocompromised (e.g. HIV infection or chemotherapy in the last three years);
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 |
|---|---|---|
| sinus floor augmentation with bone graftAlso: LASFEsinus floor augmentation with lateral approach with bone graft | Procedure or surgery | control, test HA, test HA vicryl, test HA-PRF |
Primary outcome
comparison of histological performance of the bone grafts
Time frame: 6 months after surgery
histomorphometric analysis
2 secondary outcomes
implant success
Time frame: 6 months after surgery
comparison of radiological evidence of the bone grafts
Time frame: before surgery and 6 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2021.
- Background: PubMed 21320169Farina R, Pramstraller M, Franceschetti G, Pramstraller C, Trombelli L. Alveolar ridge dimensions in maxillary posterior sextants: a retrospective comparative study of dentate and edentulous sites using computerized tomography data. Clin Oral Implants Res. 2011 Oct;22(10):1138-1144. doi: 10.1111/j.1600-0501.2010.02087.x. Epub 2011 Feb 15.
- Results publication: PubMed 15626319Del Fabbro M, Testori T, Francetti L, Weinstein R. Systematic review of survival rates for implants placed in the grafted maxillary sinus. Int J Periodontics Restorative Dent. 2004 Dec;24(6):565-77.
- Individual participant dataSharing planned: No
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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.
Claudio Stacchi, Dr. study director
Piezosurgery Academy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sinus floor augmentation with bone graft in people with Alveolar Bone Loss, run by International Piezosurgery Academy 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 11 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: finished, as of the sponsor's last update on 26 Mar 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparison of histological performance of the bone grafts (time frame: 6 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03077867, which also lists 2 linked publications.
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 26 Mar 2021.