Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02081885 |
| Other study ID # |
Chitosan-2014-1 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
January 2014 |
| Est. completion date |
January 2017 |
Study information
| Verified date |
September 2023 |
| Source |
Instituto Mexicano del Seguro Social |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Introduction After a mandibular fracture where bone has been lost, a number of complications
and challenges are presented in trying to solve them. These defects are mainly classified
into two groups: functional and cosmetic. The functional defects are incompetence of the
lower lip, salivary incontinence, severe difficulty chewing and swallowing, temporomandibular
joint disorders and difficulty in pronouncing words.
Esthetically facial asymmetry is produced with collapse of the affected side. Unreconstructed
jaw retrusion and tends to offset the affected side, there is a change in mandibular
movements, which, previous vertical movements are replaced by oblique or diagonal movements
controlled by a single temporomandibular joint. It also presents a limitation in motility and
lingual force, besides proprioception disorder left by the inferior alveolar nerve The loss
of bone in mandibular fractures, is one of the great challenges facing maxillofacial surgery
and unfortunately increasingly common. That's why they have done and are still doing research
for the development of biomaterials, all with the purpose of trying to solve this problem by
offering the patient better results than those obtained in the past, restoring both function
and facial aesthetics according to each case
Description:
Objective To evaluate the therapeutic efficacy of the combination of tricalcium phosphate and
chitosan in comparison with autologous bone graft in bone regeneration applied to surgical
mandibular fracture
Material and Methods Type of Study: Clinical Trial (Randomized) controlled This project will
be performed in patients from the Service of Plastic and Reconstructive Surgery,
Maxillofacial, Civil Hospital of Guadalajara Fray Antonio Alcalde diagnosed with facial
fractures Computed tomography imaging study with axial and coronal skull, as well as
three-dimensional reconstruction was performed, to obtain the size of the bone defect
Procedure A compound, with 5 grams of chitosan in an acidic solution, consisting of 2 ml
acetic acid 99% water, is prepared. Leaving it under constant stirring for over 12 hours to
obtain a chitosan acidic gel. The total volume of compound of chitosan will be doubly
filtered to remove impurities and microorganisms that may contaminate the solution. The first
filtration was carried out with Whatman paper No. 1 to remove residual impurities and the
second whit nitrocellulose filter of 0.45 microns to ensure complete removal of bacteria and
impurities. Once filtered, the chitosan compound be mixed with 0.2 g of tricalcium phosphate
gauge and dispensed in 15-20ml in petri dishes and incubated at dry heat stove at 40 ° C for
16 hours or until completely evaporate the liquid phase, dehydration of the compound obtained
in a thin film. The films of tricalcium phosphate and chitosan will be neutralized with 0.5%
NaOH until evolution of the petri dish and then washed thoroughly with distilled water to
remove traces of NaOH 0.5%. The film neutralized will be placed in a container for shape and
incubated for 2 hours at 50 °C for drying. Subsequently, the films will be trimmed and
sterilized in ultraviolet imager for 15 minutes and then sealed in packages of manufacturing
list for your own use.
Description of the technical surgical To the patients selected for the protocol will be
following the next described procedure; Under general inhaled anesthesia naso-tracheal via,
we will proceed to clean with an adequate asepsis and antisepsis intraoral and face
technique, sterile fields will be placed on a regular basis, and they will be infiltrate with
lidocaine and epinephrine on the incision line depending on the type of approach. After this
they will be incision in the skin and subcutaneous tissue, subsequently, with blunt
dissection in deep planes, dissection of superficial cervical fascia and muscle platysma
neck, until find the fracture traces in the jaw bone (depending on the classification on the
anatomic localization). There will be a reduction of the fracture with manual traction, and
placing a rigid bone fixation with plates and screws of titanium, and at the same time using
cooling steril physiological solution to avoid overheating of the bone (at this moment the
surgical process is identical in the two groups) after the end of this process and have a
strong jaw, is then replaced the missing bone segment, the group with autologous graft from
the iliac crest, where will be oblique incision with guidance bottom and back to the iliac
crest, 1 cm from the back of the spine and approximate length of 5 cm, previous insertions of
the abdominal muscles and external oblique Internal, until reach the periosteum.
The results package- lateral femoral cutaneous nerve and the lateral femoral cutaneous nerve
are the only structures that must not be damaged during the dissection.
A court is performed with an osteotome behind, approximately 2 cm from the edge of the ridge,
producing a fracture of the cortical leaving exposed the cancellous bone. The tables are
transected bone, by means of an osteotome behind, in order to obtain a type of cortical
graft-medullary, with a diameter no greater than 2.5 cm, the bleeding will be assessed and if
necessary materials shall be used hemostatic, finally, it was sewn by planes with vicryl 000
and skin with nylon in 0000 to the end will be placed sterile dressing.
In the case of patients who are included in the group of the biomaterial composed of
tricalcium phosphate and chitosan previously obtained in the laboratory and sterilized, will
come in predetermined diameter of 2.5 x 2.5 cm. This will be clipped and adapted to the bone
defect allowing intimate contact between the bone and the biomaterial.
When the intervention has been made (autologous graft or biomaterial), the incision will be
approached by planes with vicryl 000 and at the skin with Nylon 000 sub dermal continued
suture. At the end a sterile bandage is going to be placed and the surgery will be completed.
Statistical Analysis Nominal variables were analyzed using percentage frequencies, X2 test or
Fisher exact test. Numeric variables using Student's t test for independent samples and ANOVA
with post hoc Scheffe test. U Mann Whitney and Kruskal Wallis tests will be used as long as
data do not conform to normal distribution. All values of p <0.05 was considered
statistically significant. The analysis is going to do by using the SPSS v 17 for Windows
program.
