Comparison Synthetic Hydroxyapatite and Inorganic Bovine Bone in Sinus Floor Elevation

NCT ID: NCT03077867

Last Updated: 2021-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-15
• Study Completion Date: 2021-03-15

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.

Conditions

Alveolar Bone Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

test HA

synthetic hydroxyapatite alone sinus floor augmentation with bone graft

Group Type: EXPERIMENTAL

sinus floor augmentation with bone graft

Intervention Type: PROCEDURE

sinus floor augmentation with lateral approach with bone graft

test HA vicryl

synthetic hydroxyapatite mixed with polylactic-polyglycolic acid sinus floor augmentation with bone graft

Group Type: EXPERIMENTAL

sinus floor augmentation with bone graft

Intervention Type: PROCEDURE

sinus floor augmentation with lateral approach with bone graft

test HA-PRF

synthetic hydroxyapatite mixed with i-PRF sinus floor augmentation with bone graft

Group Type: EXPERIMENTAL

sinus floor augmentation with bone graft

Intervention Type: PROCEDURE

sinus floor augmentation with lateral approach with bone graft

control

anorganic bovine bone sinus floor augmentation with bone graft

Group Type: ACTIVE_COMPARATOR

sinus floor augmentation with bone graft

Intervention Type: PROCEDURE

sinus floor augmentation with lateral approach with bone graft

Interventions

sinus floor augmentation with bone graft

sinus floor augmentation with lateral approach with bone graft

Intervention Type: PROCEDURE

Other Intervention Names

LASFE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Trieste

OTHER

Sponsor Role: collaborator

International Piezosurgery Academy

OTHER

Sponsor Role: lead

Responsible Party

Mr. Claudio Stacchi, DDS, MSc

President of the International Piezosurgery Academy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Claudio Stacchi, Dr.

Role: STUDY_DIRECTOR

Piezosurgery Academy

Locations

Piezosurgery Academy

Parma, , Italy

Countries

Italy

References

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.

Reference Type: BACKGROUND

PMID: 21320169 (View on PubMed)

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.

Reference Type: RESULT

PMID: 15626319 (View on PubMed)

Other Identifiers

SINBYO

Identifier Type: -

Identifier Source: org_study_id