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Predictors For Transosseous Maxillary Sinus Lift Complications

Predictors For Transosseous Maxillary Sinus Lift Complications: A Prospective Cohort Study

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07017413
Acronym
PMSL
Enrollment
60
Registered
2025-06-12
Start date
2024-11-30
Completion date
2025-12-12
Last updated
2025-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maxillary Sinus Elevation, Sinus Lift Surgery Complications

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

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.

Interventions

PROCEDURETransosseous Maxillary Sinus Lift using Osseodensification

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.

Sponsors

University of Baghdad
Lead SponsorOTHER

Study design

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.

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Composite incidence of maxillary sinus membrane perforation and graft displacement, and identification of associated predictorsIntraoperative phase to 1 month post-surgeryThis 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

MeasureTime frameDescription
Postoperative Infection RateWithin 3 months postoperativelyIncidence of infection or sinusitis following the transcrestal sinus lift procedure, confirmed clinically or radiographically.

Countries

Iraq

Contacts

Primary ContactMustafa Al-Jamal, BDS, MSc, PhD
dr.mustafa.faisal9@gmail.com+9647704681045
Backup ContactAhmed Quisi, BDS. FIBMS
ahmed.fadhil@codental.uobaghdad.edu.iq+9647811896313

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026