Transcrestal Sinus Lift Using Osseodensification Versus Lateral Window Technique

Study Overview
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Brief Summary
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The aim of this study is to evaluate the transcrestal sinus lift using Osseodensification versus lateral window technique with simultaneous implant placement.

Detailed Description
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In Group 1, crestal maxillary sinus floor elevation will be done using Osseodensification. An incision will be made near the palate, and a conservative flap will be elevated. Osseodensification burs will be used to create an osteotomy and elevate the sinus membrane gradually. The osteotomy will be filled with bone graft, and the implant will be inserted. In Group 2, lateral maxillary sinus floor elevation will be performed by creating a bony window in the lateral wall of the sinus. The sinus floor will be carefully elevated using sinus elevation curettes. If there's a membrane perforation, a collagen membrane will be applied. Bone substitute material will be packed into the sinus, and a resorbable membrane will be placed over the window before suturing. Both groups will use Nanobone as the graft material.

Official Title
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Transcrestal Sinus Lift Using Osseodensification Versus Lateral Window Technique With Simultaneous Implant Placement

Conditions
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Dental Implant, Sinus Lifting

Intervention / Treatment
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* Procedure: Crestal Maxillary Sinus Floor Elevation using Osseodensification
* Procedure: Lateral Maxillary Sinus Floor Elevation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with residual bone height from 4-6 mm and bone quality is D3 or D4. Patients had to require implant treatment in the posterior maxilla. All patients will sign a consent form before the study. Exclusion Criteria: 1- Sinus pathology that precludes routine sinus augmentation. All contraindications of dental implants.11,12 Heavy smokers.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1: Crestal Maxillary Sinus Floor Elevation using Osseodensification:<br>A crestal incision will be made towards the palate for better wound closure. A conservative flap will be raised, extending beyond the alveolar crest to minimize complications. In cases with 4-6mm ridge height and a need for 3mm vertical depth, a narrow densifying bur will be used, followed by wider burs to elevate the sinus membrane. The Densah® Bur will compact graft material to lift the membrane without penetrating the sinus floor. The osteotomy will be filled with bone graft substitute, and the final bur will apically propel the graft for vertical augmentation. Implant placement follows confirmation via radiography. | Procedure: Crestal Maxillary Sinus Floor Elevation using Osseodensification<br>* Patients will be prepared for surgery with local anesthesia and thorough oral cavity disinfection. A full thickness crestal incision will be made slightly towards the palate to enhance the possibility of achieving primary wound closure. A conservative flap will be raised, extending slightly beyond the alveolar crest, to minimize flap-related issues. After preparing the osteotomy site using Densah burs and elevating the sinus to the desired height, the implant will be inserted into the osteotomy site.<br>|
| Experimental: Group 2: Lateral Maxillary Sinus Floor Elevation<br>In the Lateral technique, a crestal incision and mucoperiosteal flap will expose the sinus's lateral wall. A bony window is created, and when removable, sinus elevation curettes are used to elevate the sinus floor cautiously. Membrane perforations are covered with a resorbable collagen membrane if needed. Implant osteotomies follow standard protocol. Graft material mixed with saline is gently packed into the sinus to achieve the desired bone height. A resorbable membrane is placed on the window's outer surface, and the flap is sutured for primary closure. | Procedure: Lateral Maxillary Sinus Floor Elevation<br>* A crestal incision with an anterior vertical releasing incision exposes the sinus's lateral wall. A mucoperiosteal flap is carefully reflected, revealing the sinus. A bony window is created using a Piezoelectric device, and after elevation, the sinus floor is carefully lifted with various curettes. Implant osteotomies follow standard placement protocol, with precautions against sinus membrane perforation. Nanobone is used as graft material, mixed with saline and gently packed into the sinus. A resorbable membrane is placed on the window's outer surface, secured with circumferential resorbable sutures, and the flap is sutured for closure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone height gain | In Millimeter(mm) | Immediate post-operative, 6 Months post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ridge height | In Millimeter(mm) | Immediate post-operative, 6 Months post-operative | 
| Implant stability | In implant stability quotient (ISQ) | Immediate post-operative, 6 Months post-operative | 
| Bone Density | In Hounsfield units (HU) | Immediate post-operative, 6 Months post-operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osseodensification, Densah Burs, Internal Sinus lifting, External Sinus lifting