This is a prospective, randomized, controlled, parallel group Phase 1/2 assessment of the safety of GINTUIT versus Bio-Gide in subjects who have a posterior tooth requiring extraction. The incidence and severity of adverse events will be summarized by group (GINTUIT and Bio-Gide).
This study will evaluate the safety of GINTUIT as compared with Bio-Gide in subjects who have a posterior tooth requiring extraction. The use of GINTUIT in this investigational clinical indication may eliminate/reduce the need for aggressive flap advancement with its concomitant morbidity, while, at the same time, obtaining stable closure over a grafted socket. It is anticipated that GINTUIT will facilitate tissue granulation, followed by tissue coverage with site appropriate tissue (ie, keratinized tissue) that is needed for long term stability of the final restoration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
5
Kevin G. Murphy and Associates, P.A.
Baltimore, Maryland, United States
Number of participants with adverse events
Time frame: up to 12 months post treatment
Optimal product configuration (ie, single, folded, or z-folded)
Subjective assessment based on the results of the analyses of safety, efficacy and product handling (from surgeon input) data
Time frame: One month after placement of Gintuit in the last subject in the last successful cohort
Number of participants reporting loose graft material
Time frame: Up to 21 days post treatment
Percentage of participants with soft tissue closure
Time frame: Up to 4 weeks post treatment
Measurements of bone height
Time frame: Up to 6 months post treatment
Gintuit product handling
Rated as excellent, very good, good, adequate, poor
Time frame: At Day 0
Number of participants with visible loss of graft material
Time frame: Up to 3 months post treatment
Percentage of participants with convex, normal and concave soft tissue contour
Time frame: Up to 6 months post treatment
Measurement of soft tissue ridge contour
Time frame: Up to 6 months post treatment
Measurement of soft tissue thickness
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Time frame: Up to 6 months post treatment
Percentage of participants with color and texture match
Time frame: Up to 6 months post treatment
Percentage of participants with a clinically significant physical reduction of crestal ridge height
Clinically significant defined as \> 2 mm loss at the crest of the ridge at the graft site compared to Day 0
Time frame: Up to 6 months post treatment
Measurements of soft tissue ridge height
Time frame: Up to 6 months post treatment
Measurements of ridge width of hard tissue
Time frame: Up to 6 months post treatment
Bone quality
Regularity and density of the cortical and trabecular bone using the system described by Norton and Gamble (Quality Levels 1, 2/3, 4 and 4 (failure zone))
Time frame: Up to 6 months post treatment
Percentage of participants with acceptable implant stability
Acceptable implant stability defined as an implant stability quotient of \>/= 55
Time frame: Up to 12 months post treatment