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NCT Number: NCT07017413

Predictors For Transosseous Maxillary Sinus Lift Complications

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

College of Dentistry , University of Baghdad, Baghdad, Bab Almodaum, Iraq

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. Postoperative Infection Rate

    Time frame: Within 3 months postoperatively

    Incidence of infection or sinusitis following the transcrestal sinus lift procedure, confirmed clinically or radiographically.

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed Quisi, BDS. FIBMS

CONTACT

[email protected]

+9647811896313

Mustafa Al-Jamal, BDS, MSc, PhD

CONTACT

[email protected]

+9647704681045

Sponsors and collaborators

Lead sponsor

University of Baghdad

Other

Registry information

Official study title

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

Acronym: PMSL

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 12, 2025
Registry last updated
Jun 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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