Wound Heal Clinical Trial
Official title:
The Effect of Advanced Platelet Rich Fibrin in Alveolar Defect After Removal of Bilateral Mandibular Third Molar
To evaluate the healing effect of advanced platelet-rich fibrin (blood clot charged with growth factors) taken from the patient own blood on the extraction site.
This is a randomized double-blind clinical study. A preoperative and radiographic evaluation
will be done in order to select the patients.
Inclusion criteria are healthy patients above 18 years old with vertical or mesioangular
bilateral impacted mandibular third molars. Exclusion criteria are missing second molars or
indicated for extraction (un-restorable and remaining roots), patients under
immunosuppressant and patients with acute infection. Those who fail to attend for follow-up
appointments will be excluded.
The probing depth (PD) and clinical attachment level (CAL) distal to the second molar will be
measured before each procedure. All patients will undergo bilateral removal of 3rd molar in a
single appointment. Envelope flap with distal extension and a full-thickness mucoperiosteal
flap will be utilized and the teeth will be removed with elevators. Bone removal will be
utilized if needed.
Following the extraction, venous blood will be withdrawn to fill 2 tubes of 10mL each
(sterile vacuum plain tube for A-PRF™ +). The blood tubes will be spun in the centrifugation
machine for 13 minutes at 1300 rpm then it is pressed in PRF Box to form PRF clots which will
be placed in one the extraction socket while the other socket will not receive a PRF
(control).Randomization will be done using a coin toss.
Both extraction cavities will be closed using 3-4 interrupted sutures using 3.0 chromic gut
sutures.
Postoperatively, all patients will be treated with oral antibiotic amoxicillin 500 mg and
non-steroidal anti-inflammatory medications ibuprofen 600mg in case. also, all patients will
be instructed to rinse with 0.2 % Chlorhexidine mouthwash for seven days postoperative.
On the 7th,15th and 90th days, patients will be asked about pain using visual analog scale
(VAS) and whether they have any concern related to extraction socket statuses like halitosis,
empty socket, open socket, dehiscence, and infection signs including swelling, pus, or fever.
They will also undergo a clinical examination at this visit and the consecutive visits. The
following measures will be assessed during each clinical examination: the presence of a
pocket distal to the adjacent second molar measuring the pocket depth and clinical attachment
level and any signs of infection.
Data will be analyzed using statistical software. Analysis of multivariate regression will be
used. The healing status will be compared between the graft site and the control site.
Results will be interpreted to be statistically significant if they have a P-value of less
than 0.05
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