Adjunctive Benefit of Xenograft Plus a Membrane During Sinus Crestal Approach
Primary Purpose
Edentulous Jaw
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Transcrestal approach for sinus lift
Xenograft application
Sponsored by
About this trial
This is an interventional treatment trial for Edentulous Jaw focused on measuring Dental implant, Sinus lift, maxillary atrophy, biomaterials
Eligibility 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)
Sites / Locations
- AOUSRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Crestal sinus lift
Crestal sinus lift with adjunctive xenograft
Arm Description
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)
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.
Outcomes
Primary Outcome Measures
Complications rate
amount of complications assessed at patient level
Secondary Outcome Measures
Peri-implant bone stability
the amount (mm) of crestal bone resorption after implant placement assessed through intraoral radiographs
Implant stability quotient
implant stability assessed by resonance frequency analysis
Soft tissue inflammation
percentage of peri-implant soft tissue affected by inflamed connective tissue
Full Information
NCT ID
NCT04662333
First Posted
November 29, 2020
Last Updated
December 5, 2020
Sponsor
University of Siena
1. Study Identification
Unique Protocol Identification Number
NCT04662333
Brief Title
Adjunctive Benefit of Xenograft Plus a Membrane During Sinus Crestal Approach
Official Title
Adjunctive Benefit of Xenograft Plus a Membrane During Sinus Crestal Approach
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
March 1, 2023 (Anticipated)
Study Completion Date
March 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Siena
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Edentulous Jaw
Keywords
Dental implant, Sinus lift, maxillary atrophy, biomaterials
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Crestal sinus lift
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Crestal sinus lift with adjunctive xenograft
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Transcrestal approach for sinus lift
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Xenograft application
Intervention Description
Before implant placement, xenogenic collagen membrane and bone granules will be pushed under the Schneiderian's membrane through the surgical site.
Primary Outcome Measure Information:
Title
Complications rate
Description
amount of complications assessed at patient level
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Peri-implant bone stability
Description
the amount (mm) of crestal bone resorption after implant placement assessed through intraoral radiographs
Time Frame
12 months
Title
Implant stability quotient
Description
implant stability assessed by resonance frequency analysis
Time Frame
baseline, 1 month, 3 months, 6 months
Title
Soft tissue inflammation
Description
percentage of peri-implant soft tissue affected by inflamed connective tissue
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicola D Discepoli, Professor
Phone
3392491188
Email
ndiscepoli@me.com
Facility Information:
Facility Name
AOUS
City
Siena
ZIP/Postal Code
53100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicola Discepoli
Email
ndiscepoli@me.com
12. IPD Sharing Statement
Learn more about this trial
Adjunctive Benefit of Xenograft Plus a Membrane During Sinus Crestal Approach
We'll reach out to this number within 24 hrs