Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04652323 |
| Other study ID # |
13.02.2019 / 2019-02/04 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2019 |
| Est. completion date |
August 1, 2020 |
Study information
| Verified date |
November 2020 |
| Source |
Eskisehir Osmangazi University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The aim of this study was to determine the subcutaneous connective tissue reactions to these
new materials.
Materials and Methods These materials were placed in polyethylene tubes and implanted into
the dorsal connective tissue of Sprague Dawley rats. The presence of inflammation, edema,
necrosis, dystrophic calcification, and thickness of fibrous capsule formation was recorded
by histological examination 7, 30, and 60 days after the implantation procedure. Inflammation
scores were defined as follows: 0 = no or few inflammatory cells, no reaction, 1 = <25 cells,
mild reaction; 2 = 25 to 125 cells, moderate reaction; and 3 = ≥125 cells, severe reaction.
Fibrous capsule thickness, necrosis, and formation of calcification were recorded.
Description:
24 Twenty-four male Sprague Dawley rats weighing 250--300 gr were used in the study. For
preliminary study, 1 one rat was used on each experimental day . During the study period, the
animals were kept in cages in groups of five and taken to daily care under standard care
conditions without restriction ofno feed and water supply restrictions.
ProRoot White MTA, Medcem Pure Portland Cement, and Medcem MTA mixed according to the
manufacturer's' instructions were filled placed into sterile p olyethylene tubules (internal
diameter: 1.3 mm internal diameter, x external diameter: 1.6 mm external diameter, x length:
5.0 mm length) sterilized with ethylene oxide gas, as specified by ISO , with using a sterile
Llentulo. Twenty-one empty polyethylene tubes remained empty to bewere used as in the control
group.
Surgical Procedures The rats were anesthetized in an ether jar, followed byand then received
intraperitoneal administration of 70- mg/kg ketamine and 10- mg/kg xylazine
intraperitoneally. The operation area (backs) of the anesthetizedeach rats were was shaved
with a certain razor blade, and the surgical area was disinfected with Betadine skin
disinfectant ,. After shaving, the operation area wasand covered with sterile drapes to be
exposed. In orderTo induce local hemostasis, operations of 0.5 cc, 0.006- mg/ml 4% articaine
containing epinephrine (Ultracaine D-S-Aventis Forte, Istanbul, Turkey) by infiltrating local
anesthesia was performedadministered.
Incision lines were determined marked on the dorsal, anterior, and posterior extremities of
the experimental animals, two in the anterior and two in the posterior region and two in the
posterior region. When determining the incision lines, cCare was taken to keep a distance of
at least 2 cm distance between the placed materials to prevent them from being affected .
Skin iIncisions of approximately 1 cm length long was performedwere made with the a sterile
scalpel in the designated areas. The cCanals were entered through the incision site with a
sterile periosteal elevator, and ducts were opened under the skin by blunt dissection
approximately 2 cm deep. Subsequently, polyethylene tubules filled with the experimental
material according toof the each groups and sterile empty polyethylene tubules for the
control groups were placed in the prepared subcutaneous canals. The incision sites were then
closed primarily using 3/0 silk sutures. Antibacterial spray was applied on the sutures.
Histological Procedures After surgery, on the 7th, 30th and 60th days, 7seven animals from
each group, (21 animals) were euthanized intraperitoneally with high doses of
thiopentalsodium (Pental, İ.E. Ulagay Med. San. , Istanbul, Turkey) administered
intraperitoneally under ether anesthesia on Days 7, 30, and 60. Then, tThe test tubules
placed were then removed together with the surrounding tissues and placed in bottles
containing 10% neutral formalin. Paraffin blocks were prepared from test samples fixed in
bottles containing 10% formalin for 2 two days. From the tissues embedded in the paraffin
blocks, 4- μm serial sections parallel to the long axis of the tube were taken cut with a
microtome (Leica SM 2000R, Leica Instruments, Wetzlar, Germany) and stained with hematoxylin
and eosin (H&E).
All histological evaluations were performed The tissue samples were histologically examined
under an optical microscope (Nikon Eclipse E 600, Nikon Corp., Tokyo, Japan) at 40×x, 100×x,
200×x, and 400×x magnifications. All the slides were examined and rated by a pathologists
blinded to all procedures.
