Adjunctive Benefit of Xenograft Plus a Membrane During Sinus Crestal Approach
NCT ID: NCT04662333
Last Updated: 2020-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
36 participants
INTERVENTIONAL
2020-10-01
2023-03-01
Brief Summary
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Control group: crestal sinus lift with no adjunctive biomaterial; Test group: crestal sinus lift associated with xenogenic bone graft and collagen membrane; Six months after implant placement, implants will be loaded with definitive screw-retained prostheses.
Six months later, patients will be recalled for clinical and radiographic assessment.
Detailed Description
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Full-mouth periodontal chart and standardized radiographs will be evaluated at the time of inclusion.
Crestal sinus lift with simultaneous implant placement will be performed in both groups.
Control group: crestal sinus lift with no adjunctive biomaterial; the healing abutment in this group is made up of PEEK (poly-ether-ether-ketone).
Test group: crestal sinus lift associated with xenogenic bone graft and collagen membrane; the healing abutment in this group is made up of titanium;
Resonance frequency analysis will be performed at the time of implant placement and at 1, 3, 6 months of follow-up.
Both healing abutment will be undersized: this characteristic will allow to harvest a 1mm-wide biopsy of the transmucosal tract at the end of the healing phase (6 months).
Six months after implant placement, impression will be taken and implants loaded with definitive screw-retained prostheses.
Six months later, patients will be recalled for clinical and radiographic assessment.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Crestal sinus lift
Implant site preparation with detachment of Schneiderian membrane and subsequent implant placement. The corresponding healing abutment is made up of PEEK (poly-ether-ether-ketone)
Transcrestal approach for sinus lift
After surgical exposure of maxillary alveolar crest, implant site preparation and transcrestal detachment of Schneiderian's membrane will be performed. Thereafter implant will be placed, protruding in the maxillary sinus with its apical part.
Crestal sinus lift with adjunctive xenograft
Implant site preparation with detachment of Schneiderian membrane. After that, collagen membrane plus xenogenic bone substitute will be placed into the site before implant placement. The corresponding healing abutment is made up of titanium.
Transcrestal approach for sinus lift
After surgical exposure of maxillary alveolar crest, implant site preparation and transcrestal detachment of Schneiderian's membrane will be performed. Thereafter implant will be placed, protruding in the maxillary sinus with its apical part.
Xenograft application
Before implant placement, xenogenic collagen membrane and bone granules will be pushed under the Schneiderian's membrane through the surgical site.
Interventions
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Transcrestal approach for sinus lift
After surgical exposure of maxillary alveolar crest, implant site preparation and transcrestal detachment of Schneiderian's membrane will be performed. Thereafter implant will be placed, protruding in the maxillary sinus with its apical part.
Xenograft application
Before implant placement, xenogenic collagen membrane and bone granules will be pushed under the Schneiderian's membrane through the surgical site.
Eligibility Criteria
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Inclusion Criteria
* edentulous in posterior maxilla
* patient in need of sinus augmentation procedure
* residual bone height greater than 3mm
Exclusion Criteria
* contraindication for implant therapy
* less than 18 years
* uncontrolled periodontitis
* smoker (more than 10 cig/day)
18 Years
ALL
Yes
Sponsors
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University of Siena
OTHER
Responsible Party
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Nicola Discepoli
Professor
Locations
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AOUS
Siena, , Italy
Countries
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Central Contacts
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Facility Contacts
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Nicola Discepoli
Role: primary
Other Identifiers
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CLS001
Identifier Type: -
Identifier Source: org_study_id