Comparison Synthetic Hydroxyapatite and Inorganic Bovine Bone in Sinus Floor Elevation (SYNBIO)
Primary Purpose
Alveolar Bone Loss
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
sinus floor augmentation with bone graft
Sponsored by
About this trial
This is an interventional treatment trial for Alveolar Bone Loss focused on measuring sinus lift, synthetic hydroxyapatite, bone graft
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
- 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
Sites / Locations
- Piezosurgery Academy
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Arm Label
test HA
test HA vicryl
test HA-PRF
control
Arm Description
synthetic hydroxyapatite alone sinus floor augmentation with bone graft
synthetic hydroxyapatite mixed with polylactic-polyglycolic acid sinus floor augmentation with bone graft
synthetic hydroxyapatite mixed with i-PRF sinus floor augmentation with bone graft
anorganic bovine bone sinus floor augmentation with bone graft
Outcomes
Primary Outcome Measures
comparison of histological performance of the bone grafts
histomorphometric analysis
Secondary Outcome Measures
implant success
clinical and radiological success of implants inserted in augmented sites
comparison of radiological evidence of the bone grafts
cone beam computed tomography scans of the augmented sinuses
Full Information
NCT ID
NCT03077867
First Posted
January 25, 2017
Last Updated
March 25, 2021
Sponsor
International Piezosurgery Academy
Collaborators
University of Trieste
1. Study Identification
Unique Protocol Identification Number
NCT03077867
Brief Title
Comparison Synthetic Hydroxyapatite and Inorganic Bovine Bone in Sinus Floor Elevation
Acronym
SYNBIO
Official Title
Comparison of Histological and Radiographic Evidence After Sinus Lift With Synthetic Nano-hydroxyapatite and Inorganic Bovine Bone.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 15, 2017 (Actual)
Primary Completion Date
March 15, 2020 (Actual)
Study Completion Date
March 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
International Piezosurgery Academy
Collaborators
University of Trieste
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alveolar Bone Loss
Keywords
sinus lift, synthetic hydroxyapatite, bone graft
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
88 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
test HA
Arm Type
Experimental
Arm Description
synthetic hydroxyapatite alone sinus floor augmentation with bone graft
Arm Title
test HA vicryl
Arm Type
Experimental
Arm Description
synthetic hydroxyapatite mixed with polylactic-polyglycolic acid sinus floor augmentation with bone graft
Arm Title
test HA-PRF
Arm Type
Experimental
Arm Description
synthetic hydroxyapatite mixed with i-PRF sinus floor augmentation with bone graft
Arm Title
control
Arm Type
Active Comparator
Arm Description
anorganic bovine bone sinus floor augmentation with bone graft
Intervention Type
Procedure
Intervention Name(s)
sinus floor augmentation with bone graft
Other Intervention Name(s)
LASFE
Intervention Description
sinus floor augmentation with lateral approach with bone graft
Primary Outcome Measure Information:
Title
comparison of histological performance of the bone grafts
Description
histomorphometric analysis
Time Frame
6 months after surgery
Secondary Outcome Measure Information:
Title
implant success
Description
clinical and radiological success of implants inserted in augmented sites
Time Frame
6 months after surgery
Title
comparison of radiological evidence of the bone grafts
Description
cone beam computed tomography scans of the augmented sinuses
Time Frame
before surgery and 6 months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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;
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudio Stacchi, Dr.
Organizational Affiliation
Piezosurgery Academy
Official's Role
Study Director
Facility Information:
Facility Name
Piezosurgery Academy
City
Parma
ZIP/Postal Code
43100
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
21320169
Citation
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.
Results Reference
background
PubMed Identifier
15626319
Citation
Del 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.
Results Reference
result
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Comparison Synthetic Hydroxyapatite and Inorganic Bovine Bone in Sinus Floor Elevation
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