Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT06207578 |
Other study ID # |
IDCE.N7 |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
June 1, 2024 |
Est. completion date |
November 1, 2025 |
Study information
Verified date |
April 2024 |
Source |
Misr International University |
Contact |
Ahmed I Abo El Futtouh, Dr |
Phone |
+201019999983 |
Email |
ahmedkey7[@]hotmail.com |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
However, recently, most described techniques for posterior atrophic maxillary rehabilitation,
are targeting more conservative, cost-effective and efficient methods for sinus elevation
eliminating its lateral access. The aim of the present study is to evaluate and compare the
long-term implant stability for implants placed by the novel crestal sinus approach versus
osseodensification using Densa-bur in Atrophic Posterior Maxilla.
Description:
Rehabilitation of the edentulous posterior maxilla using osseointegrated implants is often
challenging due alveolar bone resorption, low bone density and maxillary sinus
pneumatization. Many protocols were suggested to overcome this phenomenon; placing short
implants, 2nd premolar occlusion and finally maxillary sinus elevation.
Maxillary sinus elevation is one of the most common surgical techniques used for increasing
the available bone volume to place implants and restore function and esthetics. Sinus
elevation was introduced when Boyne and James presented lateral window approach as a
modification of the Coldwell Luc technique; the access to lift the sinus floor is performed
by a window through the lateral wall. This technique was proven to be effective and
successful for sinus elevation even up to 12 mm in cases of severely atrophic ridge. It was
later divided into three techniques according to the lateral wall preparation; hinge,
elevated and complete.
Lateral approach for sinus lift is usually indicated when residual bone height is less than
5mm. While transcrestal approach can be successfully adopted when residual bone height is at
least 5 mm. Osteotome sinus floor elevation was 1st introduced by Summers (1994) and proved
to be less invasive, more conservative, less time consuming, and reduces postoperative
discomfort to the patient.
Osseodensification is a new surgical technique of biomechanical bone preparation performed
for dental implant placement where bone is compacted and autografted into open marrow spaces
and osteotomy site walls in outwardly expanding directions. The use of densah burs for
preparing implant site had many advantages including the increase of implant bone contact by
compaction autografting rather than excavation of bone in conventional drill, this mainly
depends on the viscoelastic nature of bone where time dependent stress produces time
dependent strain, it also allows for higher insertion torque and increased stability of
dental implant.
The use of densah burs for maxillary sinus lifting was first introduced by Huwais and Meyer
utilizing the advantages of the osseodensification approach for elevation of the maxillary
sinus floor. The idea of compaction autografting supported by the design of densah burs with
specially tapered geometry and specially designed flutes to compact the bone on its walls and
apex. The idea of this concept is that the special design of flutes in the densifying non
cutting mood with counter clockwise motion and presence of irrigation cause a hydraulic wave
at the apex of the bur, this wave cause pushing of the sinus membrane upward, also in
presence of grafting material cause the same effect and subsequent elevation of the
Schneiderian membranewith limited risk of perforation. So this approach is suggested to
provide a safe technique for maxillary sinus lifting with limited complications as in
osteotome or lateral approach, less perforation and less invasiveness.