Predictors For Transosseous Maxillary Sinus Lift Complications

Not Applicable

Recruiting

• Conditions: Sinus Lift Surgery Complications; Maxillary Sinus Elevation

• Registration Number: NCT07017413
• Lead Sponsor: University of Baghdad

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.

Study Timeline

• Study Start: 2024-11-30
• Study First Submitted: 2025-05-25
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-03
• Last Update Submitted: 2025-06-03
• Study First Posted: 2025-06-12
• Last Update Posted: 2025-06-12
• Primary Completion: 2025-10-30
• Study Completion: 2025-12-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Composite incidence of maxillary sinus membrane perforation and graft displacement, and identification of associated predictors	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 Outcome Measures

Name	Time	Method
Postoperative Infection Rate	Within 3 months postoperatively	Incidence of infection or sinusitis following the transcrestal sinus lift procedure, confirmed clinically or radiographically.

Trial Locations

Locations (2)

College of Dentistry , University of Baghdad; 🇮🇶 Baghdad, Bab Almodaum, Iraq

Planto clinic; 🇮🇶 Baghdad, Mansour, Iraq