Clinical trial NCT07017413: Predictors For Transosseous Maxillary Sinus Lift Complications
Official title: Predictors For Transosseous Maxillary Sinus Lift Complications: A Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sinus Lift Surgery Complications
Maxillary Sinus Elevation
Keywords: Transosseous sinus lift
Versah sinus lift
Schneiderian membrane perforation
Residual bone height RBH
Maxillary sinus
Densah bur
Implant surgery complications
Risk predictors sinus elevation
MSSM
decision tree
Lead sponsor: University of Baghdad
Sponsor class: OTHER
First posted: 2025-06-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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:

1. Residual Bone Height (RBH): Measured from the alveolar crest to the sinus floor.
2. Maxillary Sinus Ostium (MSO) Patency: Assessed radiographically to determine if ostial obstruction contributes to sinus-related events.
3. Schneiderian Membrane Thickness: Measured preoperatively via CBCT, as thicker or thinner membranes may influence perforation risk.
4. Surgical Site Location: Categorized based on the involved maxillary posterior region (e.g., premolar vs. molar).
5. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Composite incidence of maxillary sinus membrane perforation and graft displacement, and identification of associated predictors
timeFrame: Intraoperative phase to 1 month post-surgery
Secondary outcomes:
measure: Postoperative Infection Rate
timeFrame: Within 3 months postoperatively
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: College of Dentistry , University of Baghdad
state: Bab Almodaum
city: Baghdad
country: Iraq
facility: Planto clinic
state: Mansour
Study officials:
References:
citation: 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.