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

March 25, 2021 updated by: Mr. Claudio Stacchi, DDS, MSc, International Piezosurgery Academy

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
88

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Parma, Italy, 43100
        • Piezosurgery Academy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
comparison of histological performance of the bone grafts
Time Frame: 6 months after surgery
histomorphometric analysis
6 months after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
implant success
Time Frame: 6 months after surgery
clinical and radiological success of implants inserted in augmented sites
6 months after surgery
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
before surgery and 6 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
International Piezosurgery Academy

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Trieste

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Claudio Stacchi, Dr., Piezosurgery Academy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 15, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 15, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 25, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 13, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 26, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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