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

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.

Study Overview

• Status: Completed
• Conditions: Alveolar Bone Loss
• Intervention / Treatment: Procedure: sinus floor augmentation with bone graft

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
• Enrollment (Anticipated): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Parma, Italy, 43100
    • Piezosurgery Academy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

4

Arms and Interventions

Participant Group / 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 Names: 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 Names: 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 Names: 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 Names: LASFE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
comparison of histological performance of the bone grafts	histomorphometric analysis	6 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
implant success	clinical and radiological success of implants inserted in augmented sites	6 months after surgery
comparison of radiological evidence of the bone grafts	cone beam computed tomography scans of the augmented sinuses	before surgery and 6 months after surgery

Collaborators and Investigators

• Sponsor: International Piezosurgery Academy
• Collaborators: University of Trieste
• Investigators: Study Director: Claudio Stacchi, Dr., Piezosurgery Academy

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 15, 2017
• Primary Completion (ACTUAL): March 15, 2020
• Study Completion (ACTUAL): March 15, 2021

Study Registration Dates

• First Submitted: January 25, 2017
• First Submitted That Met QC Criteria: March 7, 2017
• First Posted (ACTUAL): March 13, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 26, 2021
• Last Update Submitted That Met QC Criteria: March 25, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: bone graft; sinus lift; synthetic hydroxyapatite
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Bone Diseases; Periodontal Atrophy; Bone Resorption; Alveolar Bone Loss
• Other Study ID Numbers: SINBYO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No