Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT05944939 |
| Other study ID # |
Dow Dental |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 4, 2022 |
| Est. completion date |
December 6, 2023 |
Study information
| Verified date |
October 2022 |
| Source |
Dow University of Health Sciences |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Preoperative radiograph will be taken to assess the type of impaction either mesioangular,
horizontal, distoangular and check mouth opening. Two groups involve in my study. After
taking consent from all patients in first group is control group open extraction of impacted
mandibular third molar prepared concentrated growth factor placed in fresh socket closure
done with silk 3.0. In second case group open extraction of impacted mandibular third molar
is closure with silk 3.0 without placement of concentrated growth factor.
Bone density will assessed using cone beam computed tomography 3 month and 6month
postoperatively.
Description:
Total number of patients who will fulfill the inclusion criteria of the study will be
included in the study from oral and maxillofacial surgery OPD of Dow University of health
sciences dow dental college campus. Preoperative radiograph will be taken to assess the type
of impaction either mesioangular, horizontal, distoangular and check mouth opening. Two
groups involve in my study. After taking consent from all patients in first group is control
group open extraction of impacted mandibular third molar prepared concentrated growth factor
placed in fresh socket closure done with silk 3.0. In second case group open extraction of
impacted mandibular third molar is closure with silk 3.0 without placement of concentrated
growth factor.
CONCENTRATED GROWTH FACTOR PREPARATION:
Concentrated growth factor is prepared by using patients own venous blood 10ml drawn from
patients radial forearm which placed in without anticoagulant solutions in a sterile vacuette
tubes. Centrifuged 30 sec acceleration, 2 mint -2700rmp, 4mint 2400rmp, 4 mints -2700rmp,3
mints -3000rmp, 30 sec deceleration and stop.
Concentrated growth factor contain rich growth factor taken from tube with help of tweezer
with cutting two phases with scissors where the center and bottom layers connected. When
concentrated growth factor is separated a quantity of growth factors is present at interface
between concentrated growth factor and erythrocyte layer. concentrated growth factor glue is
mould and squeezed the liquid element, to obtain a concentrated growth factor membrane and
that membrane will be stored in normal saline for future.
In second case group. After open extraction of impacted mandibular third molar fresh socket
closure will be performed with silk 3.0. Same Postoperative instruction and medication will
be given to all patients. Bone density will assessed using cone beam computed tomography 3
month and 6month postoperatively. Comparision between mesioangular with mesioangular,
distoangular with distoangular, horizontal with horizontal , vertical with vertical.(11)The
mean gray level histogram values of the cone beam computed tomography at extraction socket
will be obtained through digora software , gray scale is a digital photograpy , computer
generated imagery and colorimetry . For each defect a regions of intrest can be created for
the defect region and one the surrounding bone using the freehand selection tool, the minimum
safety distance from one pixel to any cortical structure has to be ensured,after creating
region of intrest the analysis is performed and result is transferred directly to statical
analysis sheet,(Geiger, Blem et al. 2016) The difference in mean grey level values at study
and control sites were tabulated and compared bone density. The purpose of using mandibular
third molar because third molar is most commonly impacted teeth and routinly extracted with
number of complications being reported and overcome these complication we are using CGF in
third molar socket
