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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gintuit | Experimental | Subjects with a posterior tooth (molar or premolar) socket created by atraumatic extraction will be grafted with freeze-dried bone allograft (ie, MinerOssâ„¢). The primary wound bed will consist of exposed alveolar bone and bone graft imbedded in coagulum of blood from the socket for both treatments. The test treatment GINTUIT will be inlayed within the defect over the socket graft material, and stabilized with resorbable tacking sutures. An additional single layer of GINTUIT will cover the entire surface of the extraction socket at approx. 2-3 mm beyond the margins of the wound and fixed with non-resorbable sutures. The lower layer of this additional layer should be in contact with the previously applied GINTUIT. |
|
| Bio-Gide | Active Comparator | Subjects with a posterior tooth (molar or premolar) socket created by atraumatic extraction will be grafted with freeze-dried bone allograft (ie, MinerOssâ„¢). The primary wound bed will consist of exposed alveolar bone and bone graft imbedded in coagulum of blood from the socket for both treatments. The control treatment will be a collagen membrane (ie, Bio-Gide, applied per the Package Insert) inlayed within the defect over the socket graft material, and stabilized with resorbable tacking sutures. Crossed suspensory type sutures should also be placed over Bio-Gide, depending on the degree of stabilization needed. In all subjects, care should be taken in suturing to avoid advancement of the buccal gingival flap. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gintuit | Biological | One time placement of Gintuit over socket graft. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | up to 12 months post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | One month after placement of Gintuit in the last subject in the last successful cohort |
| Number of participants reporting loose graft material |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin G. Murphy, DDS, MS | Kevin G. Murphy Associates, P.A. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kevin G. Murphy and Associates, P.A. | Baltimore | Maryland | 21209 | United States |
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| Bio-Gide |
| Device |
One time placement of Bio-Gide over socket graft. |
|
| Up to 21 days post treatment |
| Percentage of participants with soft tissue closure | Up to 4 weeks post treatment |
| Measurements of bone height | Up to 6 months post treatment |
| Gintuit product handling | Rated as excellent, very good, good, adequate, poor | At Day 0 |
| Number of participants with visible loss of graft material | Up to 3 months post treatment |
| Percentage of participants with convex, normal and concave soft tissue contour | Up to 6 months post treatment |
| Measurement of soft tissue ridge contour | Up to 6 months post treatment |
| Measurement of soft tissue thickness | Up to 6 months post treatment |
| Percentage of participants with color and texture match | 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 | Up to 6 months post treatment |
| Measurements of soft tissue ridge height | Up to 6 months post treatment |
| Measurements of ridge width of hard tissue | 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)) | Up to 6 months post treatment |
| Percentage of participants with acceptable implant stability | Acceptable implant stability defined as an implant stability quotient of >/= 55 | Up to 12 months post treatment |