Adjunctive Benefit of Xenograft Plus a Membrane During Sinus Crestal Approach
- Conditions
- Edentulous Jaw
- Interventions
- Procedure: Transcrestal approach for sinus liftProcedure: Xenograft application
- Registration Number
- NCT04662333
- Lead Sponsor
- University of Siena
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 36
- more than 18 years old
- edentulous in posterior maxilla
- patient in need of sinus augmentation procedure
- residual bone height greater than 3mm
- systemic chronic diseases affecting osseointegration
- contraindication for implant therapy
- less than 18 years
- uncontrolled periodontitis
- smoker (more than 10 cig/day)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Crestal sinus lift with adjunctive xenograft Transcrestal approach for sinus lift 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. Crestal sinus lift Transcrestal approach for 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) Crestal sinus lift with adjunctive xenograft Xenograft application 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.
- Primary Outcome Measures
Name Time Method Complications rate 12 months amount of complications assessed at patient level
- Secondary Outcome Measures
Name Time Method Soft tissue inflammation 6 months percentage of peri-implant soft tissue affected by inflamed connective tissue
Implant stability quotient baseline, 1 month, 3 months, 6 months implant stability assessed by resonance frequency analysis
Peri-implant bone stability 12 months the amount (mm) of crestal bone resorption after implant placement assessed through intraoral radiographs
Trial Locations
- Locations (1)
AOUS
🇮🇹Siena, Italy