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Adjunctive Benefit of Xenograft Plus a Membrane During Sinus Crestal Approach

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ClinicalTrials.gov Identifier: NCT04662333
Recruitment Status : Recruiting
First Posted : December 10, 2020
Last Update Posted : December 10, 2020
Sponsor:
Information provided by (Responsible Party):
Nicola Discepoli, University of Siena

Study Description
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Brief Summary:

Patients in need for implant-supported restoration in maxillary posterior sites with insufficient residual bone height will be randomly allocated to two different arms. Crestal sinus lift with simultaneous implant placement will be performed in both groups.

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.


Condition or disease Intervention/treatment Phase
Edentulous Jaw Procedure: Transcrestal approach for sinus lift Procedure: Xenograft application Not Applicable

Detailed Description:

Patients in need for implant-supported restoration in maxillary posterior sites with bone deficiencies will be randomly allocated to two different arms.

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Adjunctive Benefit of Xenograft Plus a Membrane During Sinus Crestal Approach
Actual Study Start Date : October 1, 2020
Estimated Primary Completion Date : March 1, 2023
Estimated Study Completion Date : March 1, 2023
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 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)
 Procedure: 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.
Experimental: 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.
 Procedure: 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.

Procedure: Xenograft application
Before implant placement, xenogenic collagen membrane and bone granules will be pushed under the Schneiderian's membrane through the surgical site.


Outcome Measures
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Primary Outcome Measures :
  1. Complications rate [ Time Frame: 12 months ]
    amount of complications assessed at patient level


Secondary Outcome Measures :
  1. Peri-implant bone stability [ Time Frame: 12 months ]
    the amount (mm) of crestal bone resorption after implant placement assessed through intraoral radiographs

  2. Implant stability quotient [ Time Frame: baseline, 1 month, 3 months, 6 months ]
    implant stability assessed by resonance frequency analysis

  3. Soft tissue inflammation [ Time Frame: 6 months ]
    percentage of peri-implant soft tissue affected by inflamed connective tissue


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • more than 18 years old
  • edentulous in posterior maxilla
  • patient in need of sinus augmentation procedure
  • residual bone height greater than 3mm

Exclusion Criteria:

  • systemic chronic diseases affecting osseointegration
  • contraindication for implant therapy
  • less than 18 years
  • uncontrolled periodontitis
  • smoker (more than 10 cig/day)
Contacts and Locations
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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): NCT04662333


Contacts
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Contact: Nicola D Discepoli, Professor 3392491188 ndiscepoli@me.com

Locations
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Italy
AOUS Recruiting
Siena, Italy, 53100
Contact: Nicola Discepoli       ndiscepoli@me.com   
Sponsors and Collaborators
University of Siena
More Information
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Responsible Party: Nicola Discepoli, Professor, University of Siena
ClinicalTrials.gov Identifier: NCT04662333    
Other Study ID Numbers: CLS001
First Posted: December 10, 2020    Key Record Dates
Last Update Posted: December 10, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Nicola Discepoli, University of Siena:
Dental implant
Sinus lift
maxillary atrophy
biomaterials
Additional relevant MeSH terms:
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Jaw, Edentulous
Mouth, Edentulous
Mouth Diseases
Stomatognathic Diseases
 Tooth Diseases
Jaw Diseases
Musculoskeletal Diseases