A split-mouth study comparing soft tissue augmentation results using free gingival graft (FGG) versus xenogeneic collagen matrix (CM) for the generation of keratinized tissue (KT) around teeth with insufficient (\< 2mm) KT.
A single-blind, randomized, controlled, split-mouth study of 30 subjects with insufficient zones of KT (\< 2mm). The study utilized a within subject treatment comparison design to establish non-inferiority of the test (CM) versus control (FGG) therapy. The primary efficacy endpoint was KT width at 6-months. Secondary endpoints included traditional periodontal measures, such as clinical attachment, recession and bleeding on probing. Patient reported pain, discomfort and esthetic satisfaction were also recorded. Biopsies were obtained at 6-months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
30
A type I and III porcine collagen matrix, as cleared by FDA (K012423)
Autogenous, full-thickness soft tissue graft harvested from patient's palate.
Keratinized Tissue Width
Change in Keratinized Tissue width
Time frame: 6 months
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