Adjunctive Benefit of Xenograft Plus a Membrane During Sinus Crestal Approach

Study Overview
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Brief Summary
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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
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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.

Official Title
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Adjunctive Benefit of Xenograft Plus a Membrane During Sinus Crestal Approach

Conditions
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Edentulous Jaw

Intervention / Treatment
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* Procedure: Transcrestal approach for sinus lift
* Procedure: Xenograft application


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Crestal sinus lift<br>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<br>* 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.<br>|
| Experimental: Crestal sinus lift with adjunctive xenograft<br>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<br>* 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.<br>Procedure: Xenograft application<br>* Before implant placement, xenogenic collagen membrane and bone granules will be pushed under the Schneiderian's membrane through the surgical site.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications rate | amount of complications assessed at patient level | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peri-implant bone stability | the amount (mm) of crestal bone resorption after implant placement assessed through intraoral radiographs | 12 months | 
| Implant stability quotient | implant stability assessed by resonance frequency analysis | baseline, 1 month, 3 months, 6 months | 
| Soft tissue inflammation | percentage of peri-implant soft tissue affected by inflamed connective tissue | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dental implant, Sinus lift, maxillary atrophy, biomaterials