Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04787224 |
Other study ID # |
0010557 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
January 15, 2019 |
Est. completion date |
January 30, 2021 |
Study information
Verified date |
March 2021 |
Source |
Cairo University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
Vestibular socket therapy with immediate implant placement is compared in infected and
non-infected sockets regarding implant survival, bone thickness and soft tissue height .
Description:
For non infected sockets, a 15c blade (Stoma, Storz am Mark GmbH, Emmingen-Liptingen Germany)
was used to cut a 1-cm long vestibular access incision , 3-4 mm apical to the mucogingival
junction of the involved tooth. The socket orifice and the vestibular access incision were
connected by a subperiosteal tunnel that was created using a periotome and a micro-periosteal
elevator (Stoma, Storz am Mark GmbH, Emmingen-Liptingen Germany). Implants, (Biohorizons,
Birmingham, Al, USA) , were installed using a 3D printed surgical guide (Surgical Guide
Resin, Form 2, Formlabs). A flexible cortical membrane shield (OsteoBiol® Lamina, Tecnoss®,
Torino, Italy) of heterologous origin, 0.6 mm in thickness was prepared by hydrating and
trimming it. It was then tucked through the vestibular access incision, till it extended 1 mm
below the socket orifice, and stabilized using a membrane tack (AutoTac System Kit,
Biohorizons Implant Systems, Birmingham, Alabama Inc, USA) to the apical bone. The gap
between the implant and the shield/the labial plate was then filled with particulate bone
graft [75% autogenous bone chips harvested form local surgical sites and 25% inorganic bovine
bone mineral matrix (MinerOss X , Biohorizons, Birmingham, Al, USA)]. For the infected
sockets, the 6-day protocol was implemented. Atraumatic extraction of the infected tooth by
the periotome was followed by curettage, mechanical debridement and chemical irrigation using
metronidazole irrigation solution (500mg/100ml, Amrizole, Amria Pharma, Alexandria, Egypt).
The root of the involved tooth was cleaned with an ultrasonic cleaner, cut to its apical
third, reimplanted into the socket and maintained there for 6 days by bonding its crown to
the adjacent teeth using composite resin. Implant and crown placement were done as described
above for the non-infected socket group.