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Clinical Trials/NCT06126536
NCT06126536CompletedNot Applicable

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

Al-Azhar University1 site in 1 country14 target enrollmentStarted: December 7, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
14
Locations
1
Primary Endpoint
Bone height gain

Study Overview

Brief Summary

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

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Patient with residual bone height from 4-6 mm and bone quality is D3 or D
  • •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.

Arms & Interventions

Group 1: Crestal Maxillary Sinus Floor Elevation using Osseodensification:

Experimental

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.

Intervention: Crestal Maxillary Sinus Floor Elevation using Osseodensification (Procedure)

Group 2: Lateral Maxillary Sinus Floor Elevation

Experimental

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.

Intervention: Lateral Maxillary Sinus Floor Elevation (Procedure)

Outcomes

Primary Outcomes

Bone height gain

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

In Millimeter(mm)

Secondary Outcomes

  • Bone Density(Immediate post-operative, 6 Months post-operative)
  • Ridge height(Immediate post-operative, 6 Months post-operative)
  • Implant stability(Immediate post-operative, 6 Months post-operative)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mohammed Elsaid

Assistant Lecturer of Oral and Maxillofacial Surgery

Al-Azhar University

Study Sites (1)

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