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Completed

NCT Number: NCT06126536

Transcrestal Sinus Lift Using Osseodensification Versus Lateral Window Technique

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

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Key information

Conditions

Dental Implant Sinus Lifting

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dental Medicine - Al-Azhar University

Asyut, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Crestal Maxillary Sinus Floor Elevation using Osseodensification

Procedure

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.

Lateral Maxillary Sinus Floor Elevation

Procedure

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.

Primary outcomes

  1. Bone height gain

    Time frame: Immediate post-operative, 6 Months post-operative

    In Millimeter(mm)

Secondary outcomes

  1. Ridge height

    Time frame: Immediate post-operative, 6 Months post-operative

    In Millimeter(mm)

  2. Implant stability

    Time frame: Immediate post-operative, 6 Months post-operative

    In implant stability quotient (ISQ)

  3. Bone Density

    Time frame: Immediate post-operative, 6 Months post-operative

    In Hounsfield units (HU)

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Nov 13, 2023
Registry last updated
Nov 13, 2023

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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