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| ID | Type | Description | Link |
|---|---|---|---|
| AWD029397 | Other Grant/Funding Number | osteology Foundation |
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| Name | Class |
|---|---|
| Osteology Foundation | OTHER |
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The purpose of this study is to test the comparative efficacy of two surgical approaches (immediate versus delayed GBR) for the surgical reconstruction of peri-implantitis intra-bony defects in terms of the clinical, radiographical, histological, volumetric, microbiological, and patient-reported outcomes.
The investigators hypothesize that in certain clinical situations, treatment of peri-implantitis intra-bony defects with the use of a compound bone grafting material (mixture of allogenic bone substitutes) and a non-resorbable barrier membrane and following a delayed approach (test group) with initial phase of defect decontamination and initial healing phase would yield superior outcomes to that of the conventional approach (control group) of defect decontamination and regeneration at the same clinical visit while also significantly enhancing patient-reported outcomes:
H0: There is no difference between the two mentioned approaches in terms of the treatment outcomes. H1: There is a significant difference, favoring the delayed approach compared to the immediate reconstruction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Active Comparator | The subjects will receive treatment consisting of surgical defect debridement and decontamination, followed by intra-bony defect reconstruction via immediate guided bone regeneration (GBR). |
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| Test Group | Experimental | The subjects will receive a two-stage treatment consisting of the surgical removal of peri-implant granulation tissue and pocket epithelium. After 4-6 weeks, they will undergo surgical defect debridement and decontamination, followed by intra-bony defect reconstruction via immediate guided bone regeneration (GBR). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Staged peri-implant debridement and regeneration | Procedure | Peri-implant debridement will be carried our in visit one and will be followed by a second surgery for regeneration |
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| Measure | Description | Time Frame |
|---|---|---|
| Radiographic change | change in radiographic bone volume will be measured | 12 months |
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Inclusion Criteria:
No implant mobility and no evidence of occlusal overload. In patients presenting with more than one implant meeting the inclusion criteria, a single implant will be randomly selected for inclusion in the study.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Purnima Kumar, DDS, PhD | Contact | 17347632105 | kpurnima@umich.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan School of Dentistry | Recruiting | Ann Arbor | Michigan | 48109 | United States |
There are several patient level variables that can be used to identify the patient when used in combination.
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| ID | Term |
|---|---|
| D057873 | Peri-Implantitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D012038 | Regeneration |
| ID | Term |
|---|---|
| D001686 | Biological Phenomena |
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| Simultaneous peri-implant debridement and regeneration | Procedure | The peri-implant defect will be debrided and regenerated at the same visit. |
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