Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06221527 |
| Other study ID # |
Omfs 3 3 16 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 2024 |
| Est. completion date |
January 2025 |
Study information
| Verified date |
January 2024 |
| Source |
Cairo University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
HA is favorable for osteogenesis, enhancing bone growth, acting a vector for osteoinductive
compounds and promoting even distribution and increased density of newly formed bone, thereby
altering the scaffold morphology and improving mineralization. In this study 22 volunteers
will be included in this study, the volunteers will be randomly distributed into two groups
each containing 11 volunteers, one group will be treated by hyaluronic acid before fixation
and the other group will be treated by fixation only without placement of hyaluronic acid, to
compensate for drop out 13 volunteers per group
Description:
Patients of both groups will be subjected to:
1. Clinical assessment including case history including personal data,medical,surgical
history and family history
2. Radiographic assessment includes preoperative digital panomora to evaluate fracture and
to conclude presence or absence of any foreign body or pathological pathosis.
3. Signing the informed consent will be done after explaining surgical procedure. All the
patients will be nasally intubated, scrubbed and draped in the standard manner, followed
by intra-oral and extra-oral povidone-iodine (Betadine)swabbing.
Local anesthesia containing vasoconstrictor will be injected in the vestibule Incision at
lower anteriors will be done in the mucosa in a curvilinear fashion 10-15mm away from the
attached gingiva, the incision distal to the canine will be 5 mm from the attached gingival
to be superior to the mental nerve.
Submucosal dissection will be done to expose the mentalis muscle, followed by mucoperiosteal
flap elevation till inferior border exposing the fracture line.
The fracture segments will be reduced after curettage and removal of any debris.
MMF will be done to ensure proper occlusion. Two four-hole titanium miniplates will be placed
on inferior border and another one on superior border.
For the intervention group: placement of hyaluronic acid paste will be carried over gel foam
and placed between fractured segments before plate fixation.
For the control group: no hyaluronic acid paste will be applied during fixation only gel foam
between fractures segments without any additives.
Suturing using 4-0 resorbable sutures will take place after MMF release in layers, anteriorly
mentalis muscle will be closed first to prevent chin drooping followed by a continuous
running closure of mucosa.
Elastic dressing will be applied over chin region supporting the soft tissues and preventing
hematoma formation.
Post-operative care:
Avoid traumatization of the surgical site. All patients will be instructed to apply ice packs
over submental area for 15 minutes per hour for 24 hours postoperatively.
All patients will be given postoperative medication as follows:
Anti-inflammatory drug diclofenac potassium (Cataflam50mg)2tabletsevery8hoursforaweek to
relieve pain Antibiotic drug Amoxicillin/clavulanic acid tablets (Hibiotic 1gm)1gm every 12
hours for 7 days
-Benzethonium Chloride (Antiseptol mouthwash), starting from the day after the surgery 3
times daily for 10 days.
Instruct the patient not to touch or manipulate the surgical area. No consumption of tobacco
for one week postoperatively.
