OSSEODENSIFICATION BY DENSAH BURS WITH ACTIVATED PLASMA ALBUMIN GEL FOR SINUS LIFTING WITH SIMULTANEOUS IMPLANT PLACEMENT

NCT ID: NCT06360263

Last Updated: 2025-01-31

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

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-10

Study Completion Date

2024-07-10

Brief Summary

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Aim of the current study is to evaluate clinically and radiographically transcrestal sinus lifting with densah burs with the use of activated plasma albumin gel associated with simultaneous implant placement.

Detailed Description

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Conditions

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Bone Loss, Alveolar

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sinus lifting using densah bur in combination with activated plasma albumin gel

Group Type EXPERIMENTAL

Densah bur in combination with activated plasma albumin gel

Intervention Type COMBINATION_PRODUCT

Simultaneous implant placement after transcrestal maxillary sinus lifting using densah burs in combination with activated plasma albumin gel.(APAG). A full mucoperiosteal flap will be elevated, and then reflected with periosteal elevator application of first densah bur (the narrowest) with densifying mood (reverse) counterclockwise, 800-1500 revolutions per minute with copious irrigation until the sinus is reached confirm bur position with a radiograph. Then a wider densah bur (3.0) is used with the same mode and bouncing motion to elevate the sinus floor up to 3 mm in 1mm increments.The sequential densah bur will be used with the same mode and bouncing motion to elevate the the sinus floor 3 mm maximum. After achieving the final planned osteotomy diameter, the osteotomy will be filled with APAG. Then, the desired implant length is inserted.

Interventions

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Densah bur in combination with activated plasma albumin gel

Simultaneous implant placement after transcrestal maxillary sinus lifting using densah burs in combination with activated plasma albumin gel.(APAG). A full mucoperiosteal flap will be elevated, and then reflected with periosteal elevator application of first densah bur (the narrowest) with densifying mood (reverse) counterclockwise, 800-1500 revolutions per minute with copious irrigation until the sinus is reached confirm bur position with a radiograph. Then a wider densah bur (3.0) is used with the same mode and bouncing motion to elevate the sinus floor up to 3 mm in 1mm increments.The sequential densah bur will be used with the same mode and bouncing motion to elevate the the sinus floor 3 mm maximum. After achieving the final planned osteotomy diameter, the osteotomy will be filled with APAG. Then, the desired implant length is inserted.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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Inclusion Criteria

* Patient with missing maxillary premolars and molars.
* Vertical bone height of 3-5 mm.
* Good oral hygiene.
* Non smokers.

Exclusion Criteria

* Bad oral hygiene.
* Presence of infection or periapical lesions in adjacent teeth.
* Acute maxillary sinusitis.
* Bruxism or clenching.
* Medically compromised patients with a condition that affects the procedure (patients with bone diseases such as osteogenesis imperfecta and polyarthritis and patients on radiotherapy and chemotherapy)
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Esraa Salem Kamal

OTHER

Sponsor Role lead

Responsible Party

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Esraa Salem Kamal

Oral and Maxillofacial Surgery MSc Candidate

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Faculty of Dentistry, Alexandria University

Alexandria, , Egypt

Site Status

Countries

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Egypt

References

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Kamal ES, Shaaban A, Melek L. Osseodensification by Densah burs in combination with activated plasma albumin gel for transcrestal maxillary sinus lifting with simultaneous implant placement. Oral Maxillofac Surg. 2025 Sep 20;29(1):158. doi: 10.1007/s10006-025-01459-8.

Reference Type DERIVED
PMID: 40973834 (View on PubMed)

Other Identifiers

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#1-6/2023

Identifier Type: -

Identifier Source: org_study_id

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