Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Impladent LTD | UNKNOWN |
Not provided
Not provided
Not provided
The study will be a multi-site, randomized, two-arm, controlled clinical trial using OsteoGen® Plug (Test) vs Freeze-dried Bone Allograft with collagen barrier (Control) for alveolar ridge preservation (ARP) in posterior extraction sites with intact buccal cortical plates.
After tooth extraction and debridement, sockets will be packed with either test product (OGP), or control product (BioGide). Subjects will then undergo follow-up assessments conducted at day 7 (+3 days), day 14 (+3 days), and day 30 (+3 days) for oral exam, PROs, AEs, and complication assessments. Subjects will undergo follow-up assessments conducted at day 60 (+3 days) and day 90 (+3 days), for oral exam, PROs, AEs, complication assessments, standardized PA radiographs. Subjects will undergo follow-up assessments conducted at day 120 (+3 days) for oral exam, PROs, AEs, complication assessments, standardized PA radiograph, intraoral scan, and CBCT.
OPTIONAL Subjects will undergo follow-up assessments conducted at day 135 (+14 days) for oral exam, AEs, complication assessments, histologic core procurement, additional grafting assessment, prosthetic driven implant placement assessment.
Subjects will undergo follow-up assessments conducted at day 143 (+5 days) for oral exam, AEs, end of study.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OsteoGen Plug | Experimental | OsteoGen® Plug (OGP) is a combination of bovine achilles tendon collagen matrix sourced from Australia or New Zealand and bioactive resorbable calcium apatite crystals intended for ARP. It is provided to clinicians in 3 different sizes to be placed in extraction socket. |
|
| BioGide | Active Comparator | This product is SOC treatment and will be used per packaging instructions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OsteoGen Plug | Device | OsteoGen® Plug is contoured to fill the three roots of the socket. Plug is delivered dry into a thoroughly debrided and actively bleeding socket. The OsteoGen® Plug is condensed firmly into the socket. |
| Measure | Description | Time Frame |
|---|---|---|
| New bone formation | new bone formation will be determined by Cone Beam Cat Scan (CBCT) at Day 120 | 120 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in ridge height compared to screening as determined by Cone Beam Cat Scan (CBCT) | two CBCTs will be compared, one from screening, the other at 120 days. | 120 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in ridge width compared to screening at 3mm and 5mm below crest | two CBCTs will be compared, one from screening, the other at 120 days. | 120 days |
| Volumetric analysis of soft tissue/ridge height and width via intraoral scans |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McClain and Schallhorn Periodontics and Implant Dentistry | Aurora | Colorado | 80012-3260 | United States | ||
Not provided
a multi-site, randomized, two-arm, controlled clinical trial using OsteoGen® Plug (Test) vs Freeze-dried Bone Allograft with collagen barrier
Not provided
Not provided
Not provided
Not provided
| BioGide | Device | BioGide is a resorbable collagen membrane |
|
Intraoral scans will be compared to baseline, pre-surgery and 120 days.
| 120 days |
| Histologic assessment of NBF (new bone formation), RG (residual graft particle) and connective tissue at 4 months if implant is placed | histology samples will be collected 4 months post implant placement for analysis on bone growth, | 4 months post implant placement |
| wound closure assessment | wound closure will be assessed at all post surgical visits. | 120 days |
| number of treatment sites requiring additional grafting at time of implant placement | oral exam of dentition to determine if any additional grafting is needed to treatment sites. | During procedure (time of implant placement) |
| cost effectiveness analysis | comparison of experimental procedure vs. standard treatment. | 120 days |
| baseline buccal plate thickness influence on outcomes | buccal plate thickness documented by CBCT will be compared to outcomes. | 120 days |
| change in phenotype | the change in soft and hard tissue thickness supporting structures of the teeth. | 120 days |
| time comparison between treatment groups from post extraction to ARP procedure completion (final suture) | time will be document for both arms from start of surgery to last suture being placed | surgical visit |
| Change in ridge width compared to screening at crest as determined by CBCT. Change in ridge width compared to baseline screening at crest as determined by CBCT. Change in ridge width compared to screening at crest as determined by CBCT. | two CBCTs will be compared, one from screening, the other at 120 days. | 120 days |
| complication type and incidence rates | complications will be collected at all visits post surgery | 120 days |
| Prosthetic driven implant feasibility assessment | a determination if implant could have been placed without additional grafting. | 120 days |
| Safety and tolerability/biocompatibility:Adverse events | adverse events will be collected from baseline visit through end of study | 120 days |
| Patient demographics and robust health history influence outcomes | patient demographics will be collected at screening and compared to outcomes at Day 120 | 120 days |
| Patient reported outcomes (pain, satisfaction) | PROs will be collected from baseline to day 120 to determine level of pain on a scale from 1 (no discomfort) to 10 (as much discomfort as i have ever felt) and satisfaction on a scale of 0 (completely dissatisfied) to 10 (completely satisfied). | 120 days |
| Clinician reported outcomes for usability (ease of use, time for each graft procedure, site vascularity) | clinicians will be asked to provide their opinions on useability of each product. Ease of use scale 0 (completely dissatisfied) to 10 (completely satisfied) and vascularity rating from 1 (avascular blood flow) to 5 (blood flow readily apparent without cortical penetration) | visit 2 post surgery |
| Long term implant assessments | optional assessment if an implant is placed at some point in the future.Details not yet specified. | post implant placement (outside of study after 120 days) |
| histology cores if implant placement in future | optional additional histology assessments may be done if implant is placed at some point in the future. | post implant placement (outside of study after 120 days) |
| Colorado Gum Care |
| Broomfield |
| Colorado |
| 80020 |
| United States |
| The Perio Studio | Boston | Massachusetts | 02108 | United States |
| Seven Lakes Periodontics | Fenton | Michigan | 48430 | United States |
| Metro West Orthodontics and Periodontics | La Vista | Nebraska | 68128 | United States |
| Perio & Implant Associates of Middle TN | Nashville | Tennessee | 37215 | United States |
| Perio Health Professionals | Houston | Texas | 77063-7229 | United States |
| Gulf Coast Periodontics | Victoria | Texas | 77904 | United States |
| WisNova Institute of Dental Specialists | Kenosha | Wisconsin | 53144-4292 | United States |