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Clinical Trials/NCT03209284
NCT03209284
Completed
Not Applicable

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

International Piezosurgery Academy1 site in 1 country30 target enrollmentJuly 15, 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Atrophy of Edentulous Maxillary Alveolar Ridge
Sponsor
International Piezosurgery Academy
Enrollment
30
Locations
1
Primary Endpoint
newly formed bone
Status
Completed
Last Updated
6 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
July 15, 2014
End Date
February 15, 2017
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
International Piezosurgery Academy
Responsible Party
Principal Investigator
Principal Investigator

Mr. Claudio Stacchi, DDS, MSc

DDS, MSc

International Piezosurgery Academy

Eligibility 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;

Exclusion Criteria

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

Outcomes

Primary Outcomes

newly formed bone

Time Frame: 6 months after surgery

assessment of newly formed bone via histomorphometric analysis

Secondary Outcomes

  • implant success(1 years after implant insertion)
  • exposed walls(10 day after surgery)

Study Sites (1)

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