Predictors For Transosseous Maxillary Sinus Lift Complications

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-30

Study Completion Date

2025-12-12

Brief Summary

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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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Detailed Description

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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.

Conditions

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Sinus Lift Surgery Complications Maxillary Sinus Elevation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

No masking is used as both the clinician and the patient are aware of the intervention being performed.

Study Groups

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Transosseous Sinus Lift Group

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.

Group Type EXPERIMENTAL

Transosseous Maxillary Sinus Lift using Osseodensification

Intervention Type 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.

Interventions

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Transosseous 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No