Transcrestal Sinus Lift Using Osseodensification Versus Lateral Window Technique

Not Applicable

Completed

• Conditions: Sinus Lifting; Dental Implant
• Interventions: Procedure: Lateral Maxillary Sinus Floor Elevation; Procedure: Crestal Maxillary Sinus Floor Elevation using Osseodensification

• Registration Number: NCT06126536
• Lead Sponsor: Al-Azhar University

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 Timeline

• Study Start: 2019-12-07
• Primary Completion: 2022-03-13
• Study Completion: 2022-03-13
• Status Verified: 2023-11
• Study First Submitted: 2023-11-07
• Study First Submitted QC: 2023-11-07
• Last Update Submitted: 2023-11-09
• Study First Posted: 2023-11-13
• Last Update Posted: 2023-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2: Lateral Maxillary Sinus Floor Elevation	Lateral Maxillary Sinus Floor Elevation	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.
Group 1: Crestal Maxillary Sinus Floor Elevation using Osseodensification:	Crestal Maxillary Sinus Floor Elevation using Osseodensification	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.

Primary Outcome Measures

Name	Time	Method
Bone height gain	Immediate post-operative, 6 Months post-operative	In Millimeter(mm)

Secondary Outcome Measures

Name	Time	Method
Ridge height	Immediate post-operative, 6 Months post-operative	In Millimeter(mm)
Implant stability	Immediate post-operative, 6 Months post-operative	In implant stability quotient (ISQ)
Bone Density	Immediate post-operative, 6 Months post-operative	In Hounsfield units (HU)

Trial Locations

Locations (1)

Faculty of Dental Medicine - Al-Azhar University; 🇪🇬 Assuit, Egypt