Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT02300246 |
| Other study ID # |
UFederalFluminense |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
Phase 1
|
| First received |
November 20, 2014 |
| Last updated |
November 21, 2014 |
| Start date |
July 2014 |
Study information
| Verified date |
November 2014 |
| Source |
Universidade Federal Fluminense |
| Contact |
Vittorio Moraschini, PhD |
| Phone |
55(21)996626930 |
| Email |
vittoriomf[@]terra.com.br |
| Is FDA regulated |
No |
| Health authority |
Brazil: Ministry of Health |
| Study type |
Interventional
|
Clinical Trial Summary
The platelet-rich fibrin (PRF), belongs to a new generation of plasma concentrate with
biomechanical processing simplified and without the need for handling blood biochemistry.
Some studies have shown the potential of PRF in release growth factors assisting and
accelerating the regeneration of soft tissues, however with contradictory results regarding
the hard tissues. The aim of this study will be to evaluate through clinical analyzes,
histomorphometric and micro-computed tomographic images, the dimensional changes, the
quantity and the quality of the tissues formed socket after extractions that receive
membranes of PRF. 15 sockets (test group) will receive a membrane of PRF after extraction
and the other 15 (control group) received no biomaterial (spontaneous healing).
Description:
1. Development methodology This study will be a randomized controlled and will be
conducted according to the principles outlined in the Declaration of Helsinki regarding
experiments on human beings. This work was submitted to the Ethics Committee, with the
approval number: CAAE: 21317113.4.0000.5243. To ensure the quality of this randomized
study, guidelines RCT-CONSORT checklist will be followed.
2. Selection of volunteers / sample The sample will consist of 30 human alveolar socket.
Selected volunteers must agree to participate in the study signed an informed consent
form and being willing to follow the guidelines and proposed timelines. The volunteers
will be treated at the Dental Clinical Research Center of the Fluminense Federal
University. The 30 teeth involved in this study should provide an indication of tooth
extraction without treatment possibilities, determined by clinical and radiological
examination.
3. Pre-Surgical Treatment Dental and medical case histories will be conducted on all
volunteers. Initially, volunteers will be selected and diagnosed by clinical
examination and periapical radiographic or cone beam tomographic to assess the need for
tooth extraction. All volunteers will undergo basic periodontal therapy and oral
hygiene instructions. Volunteers who have a risk factor for bacterial endocarditis will
be medicated with Amoxicillin 2g single dose one hour before the procedure, and for
those allergic to penicillin, will be prescribed 600g single dose of clindamycin one
hour before procedure, as recommended by the American College of Cardiology. Laboratory
tests, including blood pressure measurement, complete blood count, lipid profile,
coagulation profile and complete fasting glucose will be required for all volunteers.
4. Surgical Procedures Plaster study models are made by molding with alginate in all
volunteers, to enable construction of the measuring guides (templates) in acrylic. Also
intraoral photographs will be held. Volunteers will undergo local anesthesia (2% with
epinephrine Mepvacaína - 1: 100.00) for extraction of teeth. In all cases, the
extractions will be performed in a minimally traumatic manner and without lifting flap
with the aim of preservation tissues. Incisions intra-sulculares the free surfaces
(buccal / lingual) and proximal (mesial / distal) will be performed with a scalpel
blade 15C aiming the disruption of the periodontal fibers. The dislocation of the tooth
will be conducted with a forceps, with subsequent removal of the tooth socket. After
extraction, a rigorous inspection and curettage of the socket for the removal of
granulation tissue will be held, followed by irrigation with sterile saline.
Performed after extraction, will start to make themselves venous blood of volunteers
himself for a qualified professional with the goal of achieving the PRF membrane. For
this, will be collected with a sterile without anti-coagulant about 10 ml of blood from
the median cubital vein (arm) syringe. It will be led immediately into a test tube and
centrifuge for which will be calibrated to 2700 rpm for 12 minutes. After processing,
three phases are arranged within a test tube. The fibrin clot is obtained between the
layers of acellular layer of plasma and red blood cells. The same tube is carefully
collected and manipulated to form a membrane which is sutured with 5.0 absorbable
synthetic yarn (Vycril - Johnson & Johnson). The sutures are removed seven days after
the procedure.
The remaining fifteen sockets (control group) are not filled with any biomaterial (only
clot). Volunteers will be instructed to rinse their mouths twice daily for 15 days with
chlorhexidine gluconate 0.12%.
Queries review will be conducted in the first week for suture removal and the
subsequent second and fifth weeks.
5. Clinical Evaluation Prior to the extraction of both groups, the bands of keratinized
gingiva buccal and lingual measures are the muco-gingival line to the gingival margin,
with support from the UNC-15 periodontal probe, positioned on a template (stent )
acrylic resin. Furthermore, measurements of the gingival margin of the template, track
keratinized gingiva and the measurement from the edge of the template edge bony ridge
will be held in the regions mesial, buccal and distal of the buccal and lingual
surfaces. For the evaluation of the thickness of the tissues, a surgical caliper
located at 5mm from the gingival margin is used. The data collected will be immediately
recorded by an assistant. Clinical evaluations will be performed prior to extraction
(T1) and 120 days (T2).
6. Histomorphometric analysis At T2, an implant will be installed in the socket region.
The surgical bone obtained during the discharge procedure for implant placement through
a trephine measuring about 3mm in diameter, will be collected. It will be stored in
buffered formaldehyde, decalcified in EDTA, dehydrated in ethanol and embedded in
paraffin. Serial sections including the central portion of the bone cylinder will be
prepared parallel to the long axis, with the standard microtome in 5mm. The sections
are stained with hematoxylin and eosin. The analysis of the new tissue formed is
evaluated in Leitz microscope equipped with image capture system. Morphometric
measurements are evaluated to determine the proportion occupied by mineralized bone
(lamellar bone, immature bone), osteoid tissue (connective tissue matrix rich in
collagen and partially mineralized), bone marrow (adipocytes and vascular structures),
fibrous tissue and tissue residual (tissue elements unidentified artifacts of
preparation).
7. Micro-computed tomographics Representative non-decalcified samples will be scanned at a
resolution of 18 x 18 x 18 voxels μc3 using a micro-Pxs5-928EA cone beam CT. The GEHC
MicroView Plus ® Analysis software (GE Healthcare), will be used to create
three-dimensional reconstructions (3D) bone tissue from the scan. The tissue to be
analyzed is represented by all or fragments of tissue biopsy samples. The value scale
in grayscale will be used in each biopsy by a single calibrated examiner and anonymous.
The value of the average grayscale will be calculated and used as the representative to
evaluate bone volume (BV) and the mineral content of the tissue value. The tissue
mineral density will also be calculated.
8. Statistical analysis The results express the mean ± 95% CI. Mann-Whitney tests will be
conducted. Will be considered as significant differences when P < 0.05. Nominal data
will be evaluated by chi-square test. Alternatively, in case of no associates (extreme)
values, the Fisher exact test will be used. Continuous variables are expressed as mean
and standard deviation and analyzed for normal distribution using the Shapiro-Wilk
test. The Student t or Mann-Whitney tests will be applied for normal and non-normal
distribution, respectively.
