Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05895903 |
| Other study ID # |
07718814 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 15, 2021 |
| Est. completion date |
January 2, 2023 |
Study information
| Verified date |
May 2023 |
| Source |
University of Baghdad |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Alveolar ridge expansion is suggested for alveolar crest thicknesses of 3-5 mm.
Osseodensification (OD) and screw expansion (SE) techniques have been utilized to expand
narrow alveolar ridges (NAR). This study aims to compare the implant stability quotient (ISQ)
values of endosteal dental implants (DIs) inserted into NAR via osseodensification versus
manual screw expansion.
Description:
This study aimed to evaluate implant primary stability using Densah bur in comparison with
screw expander in narrow alveolar ridge.
The patient is instructed to gargle with 0.2% chlorhexidine mouthwash, scrubbing the perioral
area with 10% povidone iodine and draping the patient head with disposable drapes.
The surgery will be performed under local anesthesia using lidocaine hydrochloride 2% with
adrenaline 1:8000, the surgical procedure started with flap reflection. A mucoperiosteal
elevator was used to reflect the buccal and palatal flaps that were enough to expose the
crestal part of alveolar ridge with clear visibility and accessibility.
For Expander group:
The screw expanders will be use to expand the osteotomy site. The diameters will be use 2.3mm
,2.6 mm, 3 mm, 3.4 mm, 3.8 mm in a successive manner. Each expander will be screw until 10 mm
of depth is reached as mark on the expander. Each expanders is gently screwed half turn at a
time; to allow slow and gradual expansion of the bone . When necessary, the kit ratchet is
used to reach the full depth required. After the use of the final expander, an implant of
appropriate size will place.
FOR DENSAH BUR GROUP :
The Implant motor is set in an anti-clockwise direction and drilling speed is set at 1000
rpm. Densah Burs will use in increasing diameters of 2mm,2.3mm,2.5 mm, 3.0 mm,3.3mm, and 3.5
mm in asuccessive manner and under copious irrigation with sterile saline.
When the haptic feedback of the bur is encountered, pressure is modulated by a pumping motion
in and out of the osteotomy until 10mm of depth is reached as mark on the bur . After the use
of the final expander, an implant of appropriate size will place.
For both groups After implant placement, the integrity of the buccal bone will examine for
any cracks. The Smart peg* corresponding with the implant system is placed on the implant and
Osstell device is use to measure ISQ from buccal, lingual, mesial, and distal directions. For
each side, three reading were taken and an average was calculated. A healing collar will
place on the implant, then the flap will approximate and suture around healing collar.
Patients is instruct to take an antibiotic after surgery every 24 hours for a week and to
start non-steriodal anti-inflammatory drug every 8 hours for 2-3 days; to control the
possible post operative pain and edema. Antiseptic mouthwash is also continue 3 times daily
for 14 days. The patients will informe with the next appointment date so that the sutures are
to be removed after 1 week.
