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Single implant sites with bone loss can often be managed by bone grafting alone. The purpose of this study is to determine whether putting a soft tissue graft substitute over the bone graft will provide an increased benefit for improving the health, appearance, and stability of the bone and gums surrounding the implant.
The study will treat patients that need a single implant at a previously edentulous site (>3 months post extraction) that requires phenotypic modification. These patients will receive an implant with simultaneous GBR, with half of the participants also receiving an ADM graft.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Guided bone regeneration | Active Comparator | Guided bone regeneration with collagen membrane |
|
| Guided bone regeneration with Phenotype modification. | Experimental | Guided bone regeneration with an allogenic dermal matrix |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dental implant placement | Procedure | Participants will have a dental implant placed at a toothless site |
|
| Measure | Description | Time Frame |
|---|---|---|
| Horizontal linear change of the buccal bone | Radiographic changes of bone level in mm based on cone-beam computed tomography | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| The volumetric changes of the facial soft tissue | Volumetric changes in mm^3 based on intraoral digital scans | 6 months |
| The vascular changes of the facial soft tissue | Vascular changes in mm^3 based on ultrasound scans |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David Dunbar, DDS | Contact | 734-763-3346 | dgdunbar@umich.edu | |
| Alice Ou, RDH, MS | Contact | 734-763-3346 | aliceou@umich.edu |
| Name | Affiliation | Role |
|---|---|---|
| Muhammad Saleh, BDS, MSD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Recruiting | Ann Arbor | Michigan | 48109 | United States |
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| Guided bone regeneration with collagen membrane | Procedure | Participants will receive guided bone regeneration at a toothless site with bone substitute and a collagen membrane. |
|
| Guided bone regeneration with acellular dermal matrix. | Procedure | Participants will receive guided bone regeneration at a toothless site with bone substitute and an acellular dermal matrix. |
|
| 6 months |
| Peri-implant health, as defined by clinical attachment level. | Changes in clinical attachment level measurements in mm | 6 months |
| Patient-reported morbidity, satisfaction and comfort using a visual analogue scale (VAS) | Difference in survey results | 6 months |
| Clinician-reported overall treatment effectiveness | Scale from 1 (Poor) to 5 (Excellent) | 6 months |
| Histological bone density | Histomorphometry | 6 months |