Transcrestal Maxillary Sinus Floor Elevation With Injectable Bone Substitute

Study Overview
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Brief Summary
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To investigate clinical outcomes of transcrestal maxillary sinus floor elevation performed with an injectable xenograft in gel form, analyzing variables possibly influencing the results. Patients needing unilateral sinus floor elevation (residual crestal height <5 mm) for the placement of a single implant were enrolled. Xenograft in gel form was injected through a crestal antrostomy in order to elevate sinus membrane and fill the sub-antral space. Simultaneous implant placement was performed when adequate primary stability was achievable. Graft height was measured immediately after surgery (T0) and after six months of healing (T1). Univariate and multivariate regression models were built to assess associations between clinical variables with implant survival and graft height at T1.

Detailed Description
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Purpose: To investigate clinical outcomes of transcrestal maxillary sinus floor elevation performed with an injectable xenograft in gel form, analyzing variables possibly influencing the results. Methods: Patients needing unilateral sinus floor elevation (residual crestal height <5 mm) for the placement of a single implant were enrolled. Xenograft in gel form was injected through a crestal antrostomy in order to elevate sinus membrane and fill the sub-antral space. Simultaneous implant placement was performed when adequate primary stability was achievable. Graft height was measured immediately after surgery (T0) and after six months of healing (T1). Univariate and multivariate regression models were built to assess associations between clinical variables with implant survival and graft height at T1.

Official Title
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Clinical and Radiographic Outcomes Following Transcrestal Maxillary Sinus Floor Elevation With Injectable Xenogeneic Bone Substitute in Gel Form: a Prospective Multicenter Study

Conditions
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Edentulous Alveolar Ridge

Intervention / Treatment
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* Procedure: transcrestal sinus floor elevation
* Procedure: Implant placement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: residual bone crest height <5 mm and width ≥6 mm in the planned implant site; healed bone crest (at least 6 months elapsed from tooth loss/extraction); age >18 years; written informed consent given Exclusion Criteria: absolute medical contraindications to implant surgery; uncontrolled diabetes (HBA1c > 7.5%); treated or under treatment with antiresorptives; irradiated in the head and neck area in the last five years; pregnant or breastfeeding; substance abusers; psychiatric problems or unrealistic expectations; patient not fully able to comply with the study protocol. large sinus cavity (distance >12 mm between buccal and palatal walls at 10-mm level, comprising the residual alveolar crest); maxillary sinus conditions contraindicating sinus floor elevation; poor oral hygiene and motivation (Full Mouth Plaque Score >20% and or Full Mouth Bleeding Score >10%)

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Injectable TSFE<br>partially edentulous patients needing unilateral sinus floor elevation (residual crestal height <5 mm) for the placement of a single implant | Procedure: transcrestal sinus floor elevation<br>* Under local anesthesia (articaine 4% with epinephrine 1:100.000), a minimally invasive full-thickness flap was elevated to expose the alveolar crest. Clinicians were left free to choose their preferred transcrestal antrostomy technique. After checking sinus membrane integrity with visual inspection and Valsalva maneuver, pre-heated (40°C) xenogeneic porcine bone substitute in gel form (Gel 40, Tecnoss, Giaveno, Italy) was injected through the crestal antrostomy in order to elevate the membrane and fill the sub-antral space. Duration of graft injection (in seconds) was recorded using a digital chronometer. Periapical intraoperative radiographs were taken to confirm membrane elevation of at least 10 mm.<br>* Other names: crestal maxillary sinus lift;Procedure: Implant placement<br>* Simultaneous implant placement was performed when it was possible to achieve adequate primary stability in the residual crestal bone, otherwise crestal antrostomy was sealed by collagen sponges (Hemocollagene, Septodont, Saint-Maur-des-Fossés, France) and implant insertion was postponed. Flaps were sutured with Sentineri technique and single stitches using synthetic monofilament<br>* Other names: implant insertion;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| implant survival | implant survival rate after one year of prosthetic loading | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vertical bone gain | vertical bone gain (measured in mm on x-ray) six months after sinus augmentation | six months | 
| percentual graft shrinkage | % graft shrinkage during 6-month healing period | six months | 
| occurrence of complications | occurrence of any complication or adverse event | 12 months |