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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Crestal sinus lift | Active Comparator | 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 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcrestal approach for sinus lift | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Complications rate | amount of complications assessed at patient level | 12 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicola D Discepoli, Professor | Contact | 3392491188 | ndiscepoli@me.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AOUS | Recruiting | Siena | 53100 | Italy |
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| ID | Term |
|---|---|
| D007575 | Jaw, Edentulous |
| D000099066 | Atrophic Maxilla |
| ID | Term |
|---|---|
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D009057 | Stomatognathic Diseases |
| D009066 | Mouth, Edentulous |
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|
| Xenograft application | Procedure | Before implant placement, xenogenic collagen membrane and bone granules will be pushed under the Schneiderian's membrane through the surgical site. |
|
| baseline, 1 month, 3 months, 6 months |
| Soft tissue inflammation | percentage of peri-implant soft tissue affected by inflamed connective tissue | 6 months |
| D009059 |
| Mouth Diseases |
| D014076 | Tooth Diseases |
| D001862 | Bone Resorption |
| D001847 | Bone Diseases |
| D008439 | Maxillary Diseases |