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 |
|---|---|
| Osteogenics Biomedical | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to study the use of a new type of d-PTFE membrane called reinforced PTFE Mesh (RPM) with dental surgery. The regenerative outcomes of RPM membranes and collagen membrane for surgical reconstructive treatment of peri-implantitis (gum disease around implants) will be compared.
Peri-implantitis is an inflammatory response that leads to irreversible loss of implant supporting bone. This study will investigate the regenerative outcomes obtained with two membranes for surgical reconstructive treatment of peri-implantitis defects when the implant is submerged and primary wound closure is obtained. In one group the newly designed d-PTFE membrane with macropores, known as the RPM membrane will be utilized, which will be compared to the traditional collagen membrane used in the other group. The clinical, radiographic, and histologic outcomes for the regenerative treatment of peri-implantitis when utilizing the same bone graft in combination with either a collagen membrane or the RPM will be evaluated via a parallel-arm randomized controlled clinical trial.
32 patients with peri-implantitis will be recruited and randomized to receive peri-implantitis treatment with either a collagen membrane or an RPM membrane.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PTFE Mesh Membrane | Experimental | A reinforced PTFE Mesh membrane will be used to cover the bone graft. |
|
| Collagen membrane | Active Comparator | A collagen membrane will be used to cover the bone graft. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Membrane placement with bone grafting | Procedure | The diseased dental implant will be cleaned and the bone defect will be filled with bone graft and covered by a membrane. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Probing depth measurements in millimeters | To compare probing depth measurements using a periodontal probe after peri-implantitis treatment | About 5 weeks before baseline surgery and at 8.5 months after baseline surgery. |
| Bone measurements in millimeters | Bone measurements obtained from CBCT | Baseline and 8 months after baseline surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical attachment levels in millimeters | To compare clinical attachment measurements using a periodontal probe from baseline to the final follow-up visit | 8 months after baseline surgery |
| Marginal bone levels in millimeters at the implant site |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Muhammad Saleh, BDS, MSD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan School of Dentistry | Ann Arbor | Michigan | 48109 | United States |
Not provided
| ID | Term |
|---|---|
| D057873 | Peri-Implantitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D016025 | Bone Transplantation |
| ID | Term |
|---|---|
| D016378 | Tissue Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To compare marginal bone measurements from periapical radiographs
| 8 months after baseline surgery |
| Volumetric changes of grafted area in cubic millimeters | To compare volumetric bone measurements of the grafted areas from CBCT | 8 months after baseline surgery |
| D019637 |
| Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
| D014180 | Transplantation |