Edentulous Alveolar Ridge Clinical Trial
Official title:
Healing of Post-extraction Sites Using Bovine-bone Mineral: a CBCT and Histologic Randomized Controlled Clinical Study
Aim of the present investigation will be to evaluate the role of a bovine-bone mineral and a
collagen membrane as ridge augmentation procedure following tooth extraction. 20 consecutive
adult patients, requiring tooth extraction in the frontal area of the upper and lower arch
maxilla (from second premolar to second premolar), will be enrolled into the study.
After tooth extraction, sockets will be randomized and divided into two groups: in Group A
the socket will be grafted with Bio-Oss Collagen , in Group B the sockets will be grafted
with BioOss granules (small granules). The graft will be covered with porcine collagen
membrane (BioGide). Then, the flap will be sutured.
MEASUREMENTS:
The end of the study will be fixed at the 6 months evaluation after tooth extraction.
Impression will be taken before tooth extraction and after 6 months in order to create cast
models. On the cast models, using reference PVC (polyvinylchloride) guides, the horizontal
dimension of the soft tissues will be measured. One measurement per tooth will be recorded,
at T0 (before extraction) and T2 (after 6 months).
A 3D radiological image, using the CBCT technique, will be obtained at the end of the
surgical stage T1 (extraction + bone graft) and after 6 months of healing. Superimposition
will be performed in order to measure hard tissue remodelling.
After six months (T6), a a biopsy specimen will be also harvested for that augmented
extractions sockets on which an implant installation has been previously planned.
Both animal and human studies have clearly demonstrated that the healing of post extraction
sites usually results in pronounced alveolar ridge resorption, that mostly stabilized after
4 to 6 months. The marked tri-dimensional alterations of the ridge volume may jeopardize
patients' aesthetics and create anatomical difficulties for further implant placement.
Aim of the present investigation will be to evaluate the role of a bovine-bone mineral and a
collagen membrane as ridge augmentation procedure (intended as "increase of the ridge volume
beyond the skeletal envelope existing at the time of extraction") following tooth
extraction. Furthermore, the authors aim to evaluate as the collagen membrane acts when used
for "open-healing".
20 consecutive adult patients, requiring tooth extraction in the frontal area of the upper
and lower arch maxilla (from second premolar to second premolar), will be enrolled into the
study.
After local anesthesia, a buccal full thickness flap will be elevated, and then the hopeless
teeth will be gently extracted. All granulation tissue will be removed from the alveolus,
that will be rinsed with saline. At this time the post-extraction sockets will be randomized
and divided into two groups: in Group A the socket will be grafted with Bio-Oss Collagen ,
in Group B the sockets will be grafted with BioOss granules (small granules) using the
Bio-Oss Pen device.
The graft will be covered with porcine collagen membrane (BioGide). Then, the flap will be
sutured. The sutures (single sutures) will involve only the interdental gingival tissue, and
no attempt will be done to reach a complete soft tissue closure of the sockets: in the
alveolus area BioGide will be mostly left exposed, intended as "open healing" for second
intention wound healing.
The patient swill assume antibiotics per 6 days (Amoxicillin + Clavulanate 1gr), and will
rinse with Digluconate Chlorhexidine 0.20% per 14 days. At day 14 the sutures will be
removed. If, at this moment, the gingiva over the graft will not be completely closed, the
patient will use Digluconate Chlorhexidine 0.20% until the secondary closure will be
completed.
MEASUREMENTS:
The end of the study will be fixed at the 6 months evaluation after tooth extraction
(corresponding to the planned time for implant installation).
Impression will be taken before tooth extraction and after 6 months in order to create cast
models. On the cast models, using reference PVC guides, the horizontal dimension of the soft
tissues (measured perpendicular to the tangent of the dental arch at the midpoint of the
extraction site as the distance between the most prominent points buccally and orally) will
be measured. One measurement per tooth will be recorded, at T0 (before extraction) and T2
(after 6 months).
A 3D radiological image, using the CBCT technique, will be obtained at the end of the
surgical stage T1 (extraction + bone graft) and after 6 months of healing. Using a
diagnostic software, superimposition will be performed in order to measure hard tissue
remodelling.
After six months (T6), a a biopsy specimen will be also harvested for that augmented
extractions sockets on which an implant installation has been previously planned, with the
purpose of an histologic and histomorphometric evaluation (measurement of new bone formation
and measurement of remaining BioOss granules). The biopsy will be taken exactly in the area
where dental implants will be placed.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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