Clinical Trial: Comparison Synthetic Hydroxyapatite and Inorganic Bovine Bone in Sinus Floor Elevation

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Comparison of Histological and Radiographic Evidence After Sinus Lift With Synthetic Nano-hydroxyapatite and Inorganic Bovine Bone.

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 Summary:

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 a
Sponsor: International Piezosurgery Academy

Current Primary Outcome: comparison of histological performance of the bone grafts [ Time Frame: 6 months after surgery ]

histomorphometric analysis


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • implant success [ Time Frame: 6 months after surgery ]
    clinical and radiological success of implants inserted in augmented sites
  • 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


Original Secondary Outcome: Same as current

Information By: International Piezosurgery Academy

Dates:
Date Received: January 25, 2017
Date Started: January 15, 2017
Date Completion: January 15, 2021
Last Updated: March 7, 2017
Last Verified: March 2017