Degeneration; Bone Clinical Trial
Official title:
Straumann® MembraGel Comparison of a PEG Membrane and a Collagen Membrane for the Treatment of Bone Dehiscence Defects at Bone Level Implants
The aim of the study is to test in a randomized comparative study the performance of
Straumann® MembraGel (PEG Membrane) to act as a barrier for guided bone regeneration compared
to that of a standard collagen membrane (BioGide®) in the bone regeneration around Straumann®
SLActive bone level titanium implants.
Furthermore the clinical evaluation and comparison of complementary parameters describing the
bony and soft tissue environments at the surgical sites during the study period to evaluate
effectiveness and performance of the membranes.
At the primary endpoint of the study - 6 month post-operative - the vertical bone gain will
be measured for changes.
The changes will be evaluated by measuring the distance between the implant shoulder and the
first visible bone contact on the implant. The measurement will be taken on the medial and
distal aspect on the implant at site of interest. Measurements will take into account
distortion based on changes on the radiograph from the true dimension of the implant.
Intra-oral photographs will be taken at each study visit to document the initial appearance
of the soft tissue and the subsequent healing of the soft tissue post-implant placement. The
photographs will be taken buccal and occlusial at study site of interest.
The physical appearance of soft tissue (form, colour, tissue biotype, surface aspect) will be
clinically assessed by visual inspection.
In addition changes in the high of the keratinized gingiva will be assessed in mm. This will
be measured mid-crestal in buccal direction to the mucogingival border by a periodontal
probe.
Changes in gingival recession will be measured at the implant leading visit and the yearly
follow-up visit 18, 30 and 42 month post surgery. The distance between the margin of the
gingiva and the edge of the crown will be assessed at accessible buccal, palatal, distal and
medial sites.
A measurement of vertical defect height will be performed evaluating the distance of the
implant shoulder to the first bone to implant contact at surgery visit and 6-month later.
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