Predictors For Transosseous Maxillary Sinus Lift Complications

NCT07017413 | Recruiting DMC

• 1 other identifier: 1045125
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Postoperative Infection Rate

  Within 3 months postoperatively

Study Arms (1)

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.

Procedure: Transosseous Maxillary Sinus Lift using Osseodensification

Interventions

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.

Transosseous Sinus Lift Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients requiring dental implants in the posterior maxilla with a residual bone height of \< 6 mm.
• Good general health and absence of systemic conditions affecting bone healing (e.g., uncontrolled diabetes, osteoporosis).
• No history of chronic sinusitis or other significant sinus pathologies

You may not qualify if:

• Severe periodontal disease. 2- Residual bone height \> 6 mm. 3- History of previous sinus lift procedures or other maxillofacial surgeries. 4- Smokers.

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (2)

College of Dentistry , University of Baghdad

Baghdad, Bab Almodaum, 1214, Iraq

RECRUITING

Planto clinic

Baghdad, Mansour, 1456, Iraq

RECRUITING

Related Publications (1)

• 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.

  PMID: 27741329 RESULT

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking is used as both the clinician and the patient are aware of the intervention being performed.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: BDS, MSc OMFS

Model Details: 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.

Study Record Dates

• First Submitted: May 25, 2025
• First Posted: June 12, 2025
• Study Start: November 30, 2024
• Primary Completion: October 30, 2025
• Study Completion: December 12, 2025
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

IR (2)