Predictors For Transosseous Maxillary Sinus Lift Complications: A Prospective Cohort Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Baghdad
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Composite incidence of maxillary sinus membrane perforation and graft displacement, and identification of associated predictors
Study Overview
Brief Summary
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.
Detailed Description
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:
- Residual Bone Height (RBH): Measured from the alveolar crest to the sinus floor.
- Maxillary Sinus Ostium (MSO) Patency: Assessed radiographically to determine if ostial obstruction contributes to sinus-related events.
- Schneiderian Membrane Thickness: Measured preoperatively via CBCT, as thicker or thinner membranes may influence perforation risk.
- Surgical Site Location: Categorized based on the involved maxillary posterior region (e.g., premolar vs. molar).
- Amount of Vertical Lifting: The total height gained through osteotome-mediated or Densah bur-mediated elevation is recorded.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Health Services Research
- Masking
- None
Masking Description
No masking is used as both the clinician and the patient are aware of the intervention being performed.
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •1- Severe periodontal disease. 2- Residual bone height > 6 mm. 3- History of previous sinus lift procedures or other maxillofacial surgeries. 4- Smokers.
Arms & Interventions
Transosseous Sinus Lift Group
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.
Intervention: Transosseous Maxillary Sinus Lift using Osseodensification (Procedure)
Outcomes
Primary Outcomes
Composite incidence of maxillary sinus membrane perforation and graft displacement, and identification of associated predictors
Time Frame: Intraoperative phase to 1 month post-surgery
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.
Secondary Outcomes
- Postoperative Infection Rate(Within 3 months postoperatively)
Investigators
Mustafa Faisal Al-Jamal
BDS, MSc OMFS
University of Baghdad