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Comparison Synthetic Hydroxyapatite and Inorganic Bovine Bone in Sinus Floor Elevation (SYNBIO)

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ClinicalTrials.gov Identifier: NCT03077867
Recruitment Status : Active, not recruiting
First Posted : March 13, 2017
Last Update Posted : April 4, 2018
Sponsor:
Collaborator:
University of Trieste
Information provided by (Responsible Party):
Mr. Claudio Stacchi, DDS, MSc, International Piezosurgery Academy

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.

Condition or disease Intervention/treatment Phase
Alveolar Bone Loss Procedure: sinus floor augmentation with bone graft Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Comparison of Histological and Radiographic Evidence After Sinus Lift With Synthetic Nano-hydroxyapatite and Inorganic Bovine Bone.
Actual Study Start Date : January 15, 2017
Estimated Primary Completion Date : June 15, 2018
Estimated Study Completion Date : January 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Grafts
Drug Information available for: Durapatite

Arm Intervention/treatment
Experimental: test HA
synthetic hydroxyapatite alone sinus floor augmentation with bone graft
Procedure: sinus floor augmentation with bone graft
sinus floor augmentation with lateral approach with bone graft
Other Name: LASFE

Experimental: test HA vicryl
synthetic hydroxyapatite mixed with polylactic-polyglycolic acid sinus floor augmentation with bone graft
Procedure: sinus floor augmentation with bone graft
sinus floor augmentation with lateral approach with bone graft
Other Name: LASFE

Experimental: test HA-PRF
synthetic hydroxyapatite mixed with i-PRF sinus floor augmentation with bone graft
Procedure: sinus floor augmentation with bone graft
sinus floor augmentation with lateral approach with bone graft
Other Name: LASFE

Active Comparator: control
anorganic bovine bone sinus floor augmentation with bone graft
Procedure: sinus floor augmentation with bone graft
sinus floor augmentation with lateral approach with bone graft
Other Name: LASFE




Primary Outcome Measures :
  1. comparison of histological performance of the bone grafts [ Time Frame: 6 months after surgery ]
    histomorphometric analysis


Secondary Outcome Measures :
  1. implant success [ Time Frame: 6 months after surgery ]
    clinical and radiological success of implants inserted in augmented sites

  2. comparison of radiological evidence of the bone grafts [ Time Frame: before surgery and 6 months after surgery ]
    cone beam computed tomography scans of the augmented sinuses



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. indications for intervention of sinus lift with lateral approach to allow the insertion of dental implants, based on careful diagnosis and treatment plan;
  2. presence of residual bone crest with a height ≤3 mm on the maxillary sinus, at the level of the implant sites planned;
  3. 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:

  1. acute myocardial infarction within the last six months;
  2. uncontrolled bleeding disorders;
  3. uncontrolled diabetes (HBA1c> 7.5%);
  4. radiation therapy in the district head / neck in the last 24 months;
  5. immunocompromised (e.g. HIV infection or chemotherapy in the last three years);
  6. current or past treatment with intravenous bisphosphonates;
  7. allergy to bovine collagen;
  8. psychological or psychiatric diseases;
  9. abuse of alcohol or drug use;
  10. not controlled periodontal disease;
  11. sinus disorders that contraindicate the maxillary sinus lift

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03077867


Locations
Italy
Piezosurgery Academy
Parma, Italy, 43100
Sponsors and Collaborators
International Piezosurgery Academy
University of Trieste
Investigators
Study Director: Claudio Stacchi, Dr. Piezosurgery Academy

Publications of Results:
Other Publications:
Responsible Party: Mr. Claudio Stacchi, DDS, MSc, President of the International Piezosurgery Academy, International Piezosurgery Academy
ClinicalTrials.gov Identifier: NCT03077867     History of Changes
Other Study ID Numbers: SINBYO
First Posted: March 13, 2017    Key Record Dates
Last Update Posted: April 4, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mr. Claudio Stacchi, DDS, MSc, International Piezosurgery Academy:
sinus lift
synthetic hydroxyapatite
bone graft

Additional relevant MeSH terms:
Alveolar Bone Loss
Bone Resorption
Bone Diseases
Musculoskeletal Diseases
Periodontal Atrophy
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases