Alveolar Bone Loss Clinical Trial
Official title:
Comparison of Treatment Outcomes of Autogenous Block Bone Graft and Screw Tent-Pole Technique in Combination With Injectable Platelet Rich-Fibrin on Posterior Atrophic Mandible: A Split-Mouth Randomized Study
The purpose of the present study was to assess the effect of injectable platelet-rich fibrin
(i-PRF) enriched with allograft on alveolar bone regeneration when compared with autogenous
block bone graft, in the same participants.
The study was designed as a split-mouth randomized controlled trial. The patients were
randomly assigned to one of two surgical groups: the test group with i-PRF enriched
particulate allograft using the screw tent-pole technique; and the control group with
autogenous block bone harvested from the ramus area. All augmentation sites covered by
leukocytes-PRF (L-PRF) membrane. The primary outcome variable of this study was the
radiographic and histologic data collected at postoperative 6 months. The secondary outcome
variable was nerve alterations and implant survival.
Alveolar bone loss which results from tooth extraction, trauma or age-related factors, gives
rise to the functional or structural inefficiency of implant-supported prosthetic
rehabilitation. Therefore, bone augmentation techniques and graft materials are required to
improve esthetic outcomes and long-term prognosis of dental implant treatment. The purpose of
the present study is to evaluate the effect of i-PRF enriched with allograft on bone
regeneration when compared with autogenous block bone graft. The hypothesis of the study is
that i-PRF enriched with allograft will provide similar results to autogenous block bone
graft for three dimensional bone reconstruction. This split-mouth randomized study was
conducted in the Department of Oral Surgery of the School of Dentistry. The research protocol
and informed consent forms for all procedures on patients, were approved by the local ethics
committee of the University in accordance with the Helsinki Declarations of 1983.Selection of
the participants was determined by clinical and radiological examination according to the
inclusion criteria.Before augmentation surgery, the treatment allocation of bilateral
posterior atrophic mandibles were randomly assigned to one or other of the two surgical
sides: either the test group ( i-PRF + particulate allograft with screw tent-pole technique +
L-PRF) or the control group (autogenous block bone graft + L-PRF) by use of the
computer-generated method. Blood samples from thirteen participants were collected by a nurse
at the beginning of the surgery.The L-PRF preparation was performed as follows; the venous
blood samples were collected in 9 ml x 4 glass tubes without anticoagulant and immediately
centrifuged at 2700 rpm for 12 min. After the centrifugation of the samples, the red blood
cells (RBC) and platelet-poor plasma (PRP) were separated from the 'buffy coat' described as
L-PRF. Then the L-PRF was placed on a special press kit to obtain membrane form.
Non-coated, 8 ml plastic tube without anticoagulant was immediately centrifuged at 2700 rpm
for 2 min to obtain i-PRF. Following centrifugation, i-PRF was collected the tube by using a
disposable syringe and mixed with allograft material. All surgeries were performed under
local anesthesia. A mid-crestal incision was made on either side to expose the edentulous
alveolar ridge. Furthermore, a posterior releasing incision was made over the external
oblique ridge to provide access to the donor site, in control group.
Control site was treated with autogenous block bone graft and the opposite side (test site)
was treated with I-PRF enriched allograft material. L-PRF membrane was used to cover
augmentation sites.
The primary outcome variables of this study were the radiographic changes of augmented bone
at postoperative 6 months as well as the percentage of newly formed bone, graft material and
residual bone in the groups.
The secondary outcome variables were the clinical data on implant survival rate and nerve
alterations.
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