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This prospective cohort study aims to identify clinical and anatomical predictors for complications following transosseous maxillary sinus lift procedures using the Versah (Densah burs) technique. The study focuses on patients undergoing transcrestal sinus floor elevation without a lateral window, with or without simultaneous dental implant placement. Variables such as residual bone height, sinus membrane thickness, bone density, and patient-related factors are being evaluated. The objective is to enhance risk stratification and optimize treatment planning for transosseous sinus augmentation.
This prospective cohort study investigates potential predictors of complications associated with transosseous sinus lift procedures utilizing the Versah Densah burs technique. Unlike the traditional lateral approach, this method enables internal sinus floor elevation through a crestal access, minimizing invasiveness while allowing for controlled vertical augmentation.
The study population includes partially edentulous patients in need of vertical ridge augmentation in the posterior maxilla. The following parameters are evaluated as possible predictors of intraoperative and postoperative complications:
Primary outcome measures include intraoperative membrane perforation, postoperative sinusitis, implant failure, and the need for revision surgery. The study aims to establish reliable preoperative indicators to stratify complication risk, facilitate clinical decision-making, and improve patient outcomes in transosseous sinus elevation procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transosseous Sinus Lift Group | Experimental | Patients will undergo transcrestal maxillary sinus lift using the Versah® osseodensification technique. This arm aims to evaluate the predictors of surgical complications, including residual bone height (RBH), maxillary sinus ostium (MSO) status, Schneiderian membrane thickness, surgical site (tooth location), and amount of vertical lifting required. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transosseous Maxillary Sinus Lift using Osseodensification | Procedure | A surgical procedure utilizing the Versah® osseodensification technique for transcrestal sinus floor elevation. The approach involves the use of specialized Densah® burs to prepare the osteotomy and elevate the sinus membrane through a transosseous (crestal) access, avoiding the lateral window technique. No grafting materials will be used in this procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Composite incidence of maxillary sinus membrane perforation and graft displacement, and identification of associated predictors | This primary outcome assesses the intraoperative occurrence of Schneiderian membrane perforation and graft displacement during transosseous maxillary sinus lift. It also involves the identification of anatomical and surgical predictors, including residual bone height (RBH), maxillary sinus ostium patency, sinus membrane thickness, surgical site, and the amount of vertical lift performed. | Intraoperative phase to 1 month post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Infection Rate | Incidence of infection or sinusitis following the transcrestal sinus lift procedure, confirmed clinically or radiographically. | Within 3 months postoperatively |
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Inclusion Criteria:
1- Patients requiring dental implants in the posterior maxilla with a residual bone height of < 6 mm.
2- Good general health and absence of systemic conditions affecting bone healing (e.g., uncontrolled diabetes, osteoporosis).
3- No history of chronic sinusitis or other significant sinus pathologies
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mustafa Al-Jamal, BDS, MSc, PhD | Contact | +9647704681045 | dr.mustafa.faisal9@gmail.com | |
| Ahmed Quisi, BDS. FIBMS | Contact | +9647811896313 | ahmed.fadhil@codental.uobaghdad.edu.iq |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| College of Dentistry , University of Baghdad | Recruiting | Baghdad | Bab Almodaum | 1214 | Iraq |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27741329 | Result | Huwais S, Meyer EG. A Novel Osseous Densification Approach in Implant Osteotomy Preparation to Increase Biomechanical Primary Stability, Bone Mineral Density, and Bone-to-Implant Contact. Int J Oral Maxillofac Implants. 2017 Jan/Feb;32(1):27-36. doi: 10.11607/jomi.4817. Epub 2016 Oct 14. |
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Individual participant data (IPD) will not be shared due to ethical considerations and to maintain patient confidentiality. Data will only be used for the purposes of this study and will not be made publicly available.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 26, 2025 | May 25, 2025 | Prot_SAP_000.pdf |
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All enrolled patients will undergo transosseous maxillary sinus lift using the Versah Densah bur technique. Outcomes and predictors of intraoperative and postoperative complications will be assessed within this cohort.
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No masking is used as both the clinician and the patient are aware of the intervention being performed.
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| Planto clinic | Recruiting | Baghdad | Mansour | 1456 | Iraq |
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