Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT03692260 |
| Other study ID # |
CEBD-CU-2018-09-29 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 25, 2018 |
| Est. completion date |
July 1, 2019 |
Study information
| Verified date |
September 2018 |
| Source |
Cairo University |
| Contact |
Nevine AE Fathy mohammed elfath omar, a lecturer |
| Phone |
01011180702 |
| Email |
vina.alex[@]hotmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
interfragmentary gap measurement using Herbert cannulated headless screw using a 3D surgical
customized template versus titanuim plate
Description:
- Intervention for each group
1. Diagnosis
- for group I and II According to inclusion and exclusion criteria, patients are
selected after a comprehensive clinical and radiographic examination and
understanding of participant s chief complains.
- Inspection for the soft tissue laceration, edema, ecchymosis, hemorrhage,
cerebrospinal fluid leakage, gingival lacerations, mandible contour deformity,
facial asymmetry and the other facial bones bilateral palpation starting from
the condylar region descending towards the posterior border of the mandible to
look for any tenderness, step deformities or crepitus. Examination of the
integrity of the neurosensory and motor function of the injured area.
- Checking the amount of occlusal discrepancy with complete and comprehensive
examination of the dentition.
- Mandibular movements will also be checked with emphasis on maximal
Interincisal opening and midline shift in opening and closing positions.
2. Surgical planning Group I :participants will be treated using Herbert headless
cannulated screw(Zimmer® Herbert™ ,united states of America )Cannulated Bone Screw)
using 3d template GroupII :patients are treated using titanium plates (4 or 6 holes
according to each case) orthomed ,6th of October,Egypt)
3. Intra-operative procedures:
- All of the participants will be treated under general anaesthesia using nasal
intubation
- The occlusion was secured with temporary IMF and the fracture line was exposed
and manually reduced.
- Infiltration Local anesthesia with vasoconstrictor will be injected
intraorally at the incision site for hemostatic purposes and pain control.
- Scrubbing and draping of the patient will be carried out in a standard
fashion.
- An intraoral incision to expose the fracture line. Dissection and reflection
to reach the bone For the intervention group planning using the ct software to
produce a guiding template of the mandible in the normal position for the
insertion of the Herbert screw.
Reduction of the fracture -Fixation of the fractured segments through Herbert screw
using the 3D template fabricated by Plastycad 3diemme Italy(group I), or by using
titanium the plate (groupII)
- Double checking and verification of the occlusion before wound closure.
- Wounds are debrided and sutured.
4. Postoperative - Cold application at the site of surgery in the form of ice packs 10
minutes every hour in the first 6 hours.
-Broad spectrum antibiotic therapy in the form of Unasyn 1500 mg vials was given as
an IV shot to the patient every 12 hours for 5 days to reduce the risk of
infection. (Unasyn®: manufactured by Pfizer, Egypt S.A.E Cairo, A.R.E)
- Non-steroidal anti-inflammatory drug will be administered in the form of Voltaren
75mg ampoule 3 times daily for 3 days to relief the pain. (Voltaren®: NOVARTIS
PHARMA S.A.E. Cairo, under license from: Novartis Pharma AG, Basle, Switzerland.)
5. Follow up & Evaluation
Clinical follow up parameters:
For group I and group II - Dehiscence of the soft tissue and hardware exposure. -
Pain over visual analogue scale over first 72 hours.
-Maximum incisal opening (MIO)
- Stability of the fractured segments.
Radiographic follow up parameters:
- Bone union/nonunion and malunion (OPG).
- Bone to bone contact via mandible form & border contour (OPG) (3diagnosys
3diemme Italy version 4.2 Any participant that can cause an adverse effect to
the intervention/control group will be excluded
- the patients will receive their panoramic x-ray at the accurate indicated
intervals.
The the MIO will be tested for all patients under the same chair postion using the
same caliper, the visual analogue scale to measure the pain will be explained to
the patient to prevent any misunderstanding and for the sensory function the
patients will be asked to close their eyes before we start to prevent any
misleading data as he will not be able to see area we are checking. Those
Strategies will be used to improve adherence to intervention protocols.
