Influence of Anatomy of Maxillary Sinus on New Bone Formation After Transcrestal Augmentation Procedures (SLSS)

August 27, 2019 updated by: Mr. Claudio Stacchi, DDS, MSc, International Piezosurgery Academy

Influence of the Anatomical Variability of the Maxillary Sinus on New Bone Formation After Transcrestal Augmentation Procedures

The aim of this study is to analyze neoformed bone after maxillary sinus lifting with transcrestal approach, in atrophic crests (≤5 mm residual bone height). Clinical and laboratory data will be related to maxillo breast anatomy.

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

Bone resorption and sinus pneumatization, following tooth extraction, are common occurrences in the posterior maxilla. They may cause both a quantitative reduction and qualitative deterioration of bone, resulting in an inadequate bone volume for a standard implant placement. Sinus floor elevation with lateral approach had been described 35 years ago and widely studied afterwards, demonstrating an high predictability in regenerating bone, to allow for reliable implant supported rehabilitations. Maxillary sinus floor elevation with transcrestal approach represents a validated and effective alternative option to vertically enhance the available bone through an access created in the edentulous bone crest. Regardless of graft type, it is not yet well defined how three-dimensional anatomical sinus cavity characteristics may influence healing and mineralization process. An adequate Schneiderian membrane elevation in order to expose sinus floor, buccal and medial walls, seems to represent a crucial factor in influencing new bone formation, as the greatest part of the osteoprogenitor cells derives from these anatomical structures. It is not documented yet the efficacy of the different trnanscrestal sinus floor elevation approaches in exposing the internal bony walls of the sinus. Moreover, on the basis of the fact that only few articles correlated the size of the maxillary sinus with histologic outcome by lateral window and one retrospective radiographic study reported results in relation to the three-dimensional conformation of the sinus using a trans-crestal approach, the investigators conjecture that sinus bucco-palatal diameter could influence the newly-formed bone quality after a crestal sinus lift procedure. For example, the healing in a narrow maxillary sinus could result in a faster new bone formation, when compared to a larger and wider sinus. The aim of this study is to analyze neoformed bone after maxillary sinus lifting with transcrestal approach, in atrophic crests (≤5 mm residual bone height). Clinical and laboratory data will be related to maxillo breast anatomy. The present study has been designed as a multicenter prospective clinical trial. Five clinical centers will treat patients with two-stage transcrestal sinus floor elevation using a calibrated drills technique and a xenogeneic biomaterial. Implants will be inserted 6 months after sinus augmentation and bone-core biopsies will be harvested during the implant site preparation. Histological analyses will be performed in order to assess the quality of the newly-formed tissue and cone beam computed tomography scan examination will be used to evaluate graft resorption over time. For each inserted implant, collection of experimental parameters will be required up to 1 year after its placement.

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.
Observational

Enrollment (Actual)

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.
30

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

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study population was composed of all patients presenting for evaluation and management of any partial edentulism requiring unilateral maxillary sinus elevation. To be included in the study sample, patients had to present a residual crestal height on the sinus floor less than 5 mm, to be 18 years or older, and able to understand and sign a written informed consent form.

Description

Inclusion Criteria:

Local inclusion criteria will be the following:

  • indications for a transcrestal sinus floor augmentation to allow for a single implant placement, based on accurate diagnosis and treatment planning;
  • presence of a residual bone crest with a height ≤3 mm on the maxillary sinus in the site where implant placement is programmed;
  • the bone crest must be healed (at least three months elapsed after tooth loss);
  • age of the patient >18 years;
  • patient willing and fully capable to comply with the study protocol;
  • written informed consent given.

General exclusion criteria are:

  • acute myocardial infarction within the past 2 months;
  • uncontrolled coagulation disorders;
  • uncontrolled diabetes (HBA1c > 7.5%);
  • radiotherapy to the head/neck district within the past 24 months;
  • immunocompromised patient (HIV infection or chemotherapy within the past 5 years);
  • present or past treatment with intravenous bisphosphonates;
  • psychological or psychiatric problems;
  • alcohol or drugs abuse.

Exclusion Criteria:

  • Local exclusion criterion is the presence of uncontrolled or untreated periodontal disease.

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
narrow sinuses
transcrestal sinus floor elevation in narrow sinuses
Procedure: transcrestal sinus floor elevation
augmentation procedure with xenograft
Other Names:
  • implant insertion
wide sinuses
transcrestal sinus floor elevation in wide sinuses
Procedure: transcrestal sinus floor elevation
augmentation procedure with xenograft
Other Names:
  • implant insertion

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
newly formed bone
Time Frame: 6 months after surgery
assessment of newly formed bone via 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: 1 years after implant insertion
short term implant success rate via clinical and radiographic data
1 years after implant insertion
exposed walls
Time Frame: 10 day after surgery
number of sinuses exposed walls after augmentation procedure via cone beam computed tomography
10 day 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 Triste

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.
July 15, 2014

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.
September 15, 2015

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.
February 15, 2017

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).
July 4, 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.
July 5, 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.
July 6, 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.
August 28, 2019

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.
August 27, 2019

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.
August 1, 2019

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.
  • SLSS_IPA

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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