Alveolar Bone Loss Clinical Trial
Official title:
Dimensional Changes of Soft and Hard Tissues Following Alveolar Ridge Preservation: Freeze-dried Bone Allograft vs. L-PRF Clot Covered With d-PTFE Membrane: A Randomized Clinical Trial
A Clinical Trial to study the effectiveness between two, tooth socket grafting materials
namely, Freeze Dried Bone Allograft (human derived bone particles) and Leukocytic-Platelet
Rich Fibrin (the patient's own centrifuged blood).
The purpose of this study is to compare the effects (good and bad) of Bone Allograft to
Platelet Rich Fibrin to see which material would be the most effective in maintaining the
volume of the gum and bone of the jaw during the healing phase as well as minimizing the
amount of pain and/or swelling following tooth extraction.
A prospective,randomized clinical trial will be conducted to determine whether L-PRF,
compared to freeze dried bone allograft, will result in comparable volumetric shrinkage of
the alveolar ridge and overlying keratinized tissue, following extraction of teeth and socket
grafting.
This trial aims at obtaining information to determine which material would provide a superior
clinical result, as well as reporting on patient related outcomes. The participants will be
randomly assigned to two groups. The surgical procedure will be performed by one of five
calibrated periodontal residents.
Patients will be followed for 2 weeks post-operatively by the same resident, to monitor the
healing process and to assess for any complications.
Randomization will be achieved using a computerized randomization scheme and will be assigned
to one of two groups and allocated by means of a sealed envelope opened on the day of surgery
communicated to the surgeon during the surgery by a supervising faculty member. Participants
will be block-randomized for each of the 5 operators for balance.
Anesthesia will be achieved and soft tissue measurements will be obtained using a periodontal
probe. An atraumatic extraction technique will be performed to allow for minimal disturbance
of the soft and hard tissue architecture.
The extraction socket walls are then assessed and any defects in socket measured with a
periodontal probe. Group A: Full thickness mucoperiosteal pouch is created up to ~3mm apical
of the bony crest of the socket with a periosteal elevator. The socket is incrementally
filled with mineralized cortical freeze-dried bone allograft and condensed. Group B: Socket
is pouched as in group A followed by venipuncture of the antecubital vein with 21G needle and
collection of 4-6 vials (10ml each) of venous blood without any additive or anticoagulant.
The vials are centrifuged for 12 minutes at 2700 rpm to form L-PRF clots. The socket is
incrementally filled with the clots and condensed.
Following socket fill, both groups will have the grafts covered by dense
polytetrafluoroethylene membrane. The membrane is trimmed and adapted with the borders tucked
2-3mm underneath the gingival tissues. Tissues, graft and membrane are stabilized with 5/0
PTFE sutures.
The patients will also receive a pain VAS questionnaire evaluating the post-operative pain 1
and 7 days following surgery. A CBCT with the radiographic stent will be taken within 72
hours of the surgery.
7 days post-op: Sutures will be removed if deemed suitable. The VAS questionnaire will be
collected.
6 weeks post op: d-PTFE membrane will be retrieved and discarded using tissue forceps.
Alginate impressions will be taken for a surgical guide.
11 weeks post op: Second CBCT will be taken with radiographic surgical stent. Images obtained
will be used to analyze and compare the ridge dimensions to those obtained at baseline as
well as for surgical implant planning.
12 weeks post op: Soft tissue measurement with periodontal probe and floss spanned over
edentulous site from buccal to lingual mucogingival junction. Implant placement will be done
per standard procedure. A 2.5mm diameter trephine drill will be used to harvest a bone core
for histologic analysis. The bone core will be immediately submerged in a solution of 10%
neutral buffered formalin. Osteotomies and implant placement will be done following the
manufacturer's protocol. Depending on the buccal bone and soft tissue thickness, ancillary
soft tissue augmentation, bone augmentation or combination of these procedures may be
indicated. The patient will be followed up and referred to the restorative dentist as per
standard procedure. Photographs will be taken at every visit.
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