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

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ClinicalTrials.gov Identifier: NCT03209284
Recruitment Status : Completed
First Posted : July 6, 2017
Last Update Posted : August 28, 2019
Sponsor:
Collaborator:
University of Triste
Information provided by (Responsible Party):
Mr. Claudio Stacchi, DDS, MSc, International Piezosurgery Academy

Brief Summary:
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.

Condition or disease Intervention/treatment
Atrophy of Edentulous Maxillary Alveolar Ridge Procedure: transcrestal sinus floor elevation

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.

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Influence of the Anatomical Variability of the Maxillary Sinus on New Bone Formation After Transcrestal Augmentation Procedures
Actual Study Start Date : July 15, 2014
Actual Primary Completion Date : September 15, 2015
Actual Study Completion Date : February 15, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anatomy

Group/Cohort Intervention/treatment
narrow sinuses
transcrestal sinus floor elevation in narrow sinuses
Procedure: transcrestal sinus floor elevation
augmentation procedure with xenograft
Other Name: implant insertion

wide sinuses
transcrestal sinus floor elevation in wide sinuses
Procedure: transcrestal sinus floor elevation
augmentation procedure with xenograft
Other Name: implant insertion




Primary Outcome Measures :
  1. newly formed bone [ Time Frame: 6 months after surgery ]
    assessment of newly formed bone via histomorphometric analysis


Secondary Outcome Measures :
  1. implant success [ Time Frame: 1 years after implant insertion ]
    short term implant success rate via clinical and radiographic data

  2. exposed walls [ Time Frame: 10 day after surgery ]
    number of sinuses exposed walls after augmentation procedure via cone beam computed tomography


Biospecimen Retention:   Samples Without DNA
bone biopsies were retrieved at the time of implant placement (after 6 months of regenerative procedure) and obtained through implant site preparation with trephine bur


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03209284


Locations
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Italy
Piezosurgery Academy
Parma, Italy, 43100
Sponsors and Collaborators
International Piezosurgery Academy
University of Triste
Investigators
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Principal Investigator: Claudio Stacchi, Dr. Piezosurgery Academy
Publications of Results:
Other Publications:
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Responsible Party: Mr. Claudio Stacchi, DDS, MSc, DDS, MSc, International Piezosurgery Academy
ClinicalTrials.gov Identifier: NCT03209284    
Other Study ID Numbers: SLSS_IPA
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mr. Claudio Stacchi, DDS, MSc, International Piezosurgery Academy:
maxillary atrophy
transcrestal sinus floor elevation
Additional relevant MeSH terms:
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Atrophy
Pathological Conditions, Anatomical