Bone Loss Clinical Trial
Official title:
Guided Bone Regeneration With Non-resorbable Membranes Versus Titanium Meshes and Resorbable Membranes.
The objective of this study is to compare two surgical techniques for the treatment of the
mandibular bone atrophies: Dense PTFE titanium-reinforced membranes (Group A) versus Titanium
mesh covered with cross-linked collagen membranes (Group B).
Therefore, the main purposes are to compare test and control regarding (i) the percentage of
post-operative complications (ii) the three-dimensional bone gain (iii) histological,
histomorphometrical and microCT outcomes (iv) perImplant bone loss and soft tissue
parameters.
In the last 10 years, short- and long-term studies have demonstrated that GBR is a successful
and reliable technique for vertical and horizontal ridge augmentation. GBR can be achieved
with two different approaches: application of either a polytetrafluoroethylene (PTFE)
titanium-reinforced membrane (i.e., a non-resorbable membrane) or a collagen membrane (i.e.,
a resorbable membrane). To achieve vertical bone augmentation, a resorbable membrane must be
supported by a space-making device, such as a titanium mesh (Ti mesh) or a titanium
osteosynthesis plate.
However, the use of a barrier device is a technique-sensitive procedure that is not free of
complications. The main cause of GBR failure is related to early or late exposure of a
barrier device, leading to contamination and infection of the biomaterial, irreversibly
compromising bone regeneration.
This study aims to evaluate complication rates and vertical bone gain (VBG) after GBR with
dense PTFE titanium-reinforced membranes versus with titanium mesh covered with cross-linked
collagen membranes.
The primary objective of the study is, therefore, the evaluation of the healing
complications; in particular, the early or delayed exposure of medical devices used for bone
regeneration, during the healing period. This exposure is, as reported in all clinical
studies, the main cause of the failure of the surgery. A secondary objective, is the
quantitative assessment of bone regeneration obtained by the 2 techniques. In particular, the
evaluation of the reconstructed bone volume (RBV) with respect to the planned bone volume
(PBV). Other targets include the qualitative evaluation of bone regeneration through
histological and histomorphometric analysis of the bone biopsies obtained at the moment that
the medical device is removed and finally the evaluation of the peri-implant bone resorption
will be conducted over time. This study was designed as a pilot, parallel-group,
double-blind, randomized, comparative clinical trial. The study was conducted in accordance
with the principles of the Declaration of Helsinki. The study was approved by the Ethical
Committee of the Sant'Orsola-Malpighi Hospital (Prot. CMF 01/2013; number 30/2013/O/Disp).
The study included 40 patients with partial edentulism, associated with alveolar atrophy in
the posterior regions of the mandible, who were referred to the Unit of Oral and
Maxillofacial Surgery, Alma Mater Studiorum, University of Bologna, Italy.
Patients were randomized into two study groups, depending on a previous computer-generated
randomization sequence. Group A included 20 patients treated by means of a dense PTFE
(d-PTFE) titanium-reinforced membrane, and Group B included 20 patients treated by means of a
titanium mesh (Ti mesh) and cross-linked collagen membrane.
The study included 3 different treatment phases: the first phase (T0) involves bone
regeneration with Dense PTFE titanium-reinforced membranes (Group A) or Titanium mesh covered
with cross-linked collagen membranes (Group B) and simultaneous implants placement; the
second one (T1), subsequently, after 6 months, this will forsee the removal of the
regeneration devices; the third (T2), 3 months after the aforementioned, will forsee the
final functional loading of the implants, with a consequent follow-up of the regenerated
bone. All the materials and tools used in the study are CE certified and have already been
used in the normal care path for patients who have undergone bone regeneration. Moreover, the
control visits and the radiological investigations of the data were summarized in the case
report form (CRF), and are those that characterize the normal care path of patients
undergoing necessary bone regeneration for prosthetic implant rehabilitation when the bone
quantity is insufficient.
The primary objective of this study is to evaluate the non-inferiority of group B (Ti mesh)
compared to technique A (d-PTFE membrane) in the incidence of complications. The Secondary
objectives include: assessment of reconstructed bone volume (RBV) compared to planned bone
volume (PBV), histological and histomorphometric analysis of bone quality obtained and
periimplant bone resorption after 12 months of follow-up.
The sample size calculation showed that with a minimum of 17 patients per group (total of 34
patients), it will be possible to detect a 35% difference in complications and a difference
of 1 mm in VBG between the two groups with a standard deviation a=1 and a significance level
of a = 0.05 with a power of 80%. To protect from possible drop-outs, the sample size was
increased by to 20 patients per group (total of 40 patients).
The results obtained in the two study groups (Groups A and B) were subjected to statistical
description and analyses using specific tests to determine statistically significant
differences between them. Both the intent-to-treat and per-protocol populations were
analyzed. The patient was regarded as the statistical unit of analysis for all analyses,
except that of implant stability, which was carried out considering the implant as the
statistical unit. Statistical differences in complication rates were investigated using
Fisher's exact test. Differences in implant stability, peri-implant bone defects, and VBG at
T0 and T1 were investigated using t-tests for unpaired data. Statistical significance was set
at α = 0.05. The statistician was blinded and external to working group.
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