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| Name | Class |
|---|---|
| Osteogenics Biomedical | INDUSTRY |
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Dental implants have revolutionized the field of dentistry, providing improvements in function and esthetics. They are not, however, without risks. Bone loss around implants (i.e. periimplantitis) is an emerging public health concern. Untreated, peri-implantitis leads to implant loss and jawbone defects. Nonetheless, existing therapies have failed to show long-term efficacy. The pathogenesis of peri-implantitis is believed to be of bacterial etiology similar to periodontal disease. Therefore, existing treatments duplicate strategies for the treatment of natural teeth. However, the titanium (Ti) surface of implants is quite dissimilar to teeth. Recent work from our lab has demonstrated that peri-implantitis is associated with increased release of Ti particles around implants. These findings suggest that treatments targeting periimplantitis must be designed around Ti material properties. A gap in knowledge exists regarding the potential triggers of increased Ti dissolution from the implant surface and the mechanisms by which Ti dissolution products amplify peri-implant inflammation. The aim of this study is to determine if the use of tooth-driven treatment approaches increase Ti in the submucosal plaque.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tooth-borne treatment | Active Comparator | A cleaning aid that resembles tooth cleaning instruments and is empirically used for implant surface cleaning. |
|
| Implant-specific treatment | Experimental | A cleaning aid that has been specifically designed for implant surface cleaning. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tooth-borne treatment | Other | Titanium curettes |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Titanium elution | The primary outcome of the clinical trial will be titanium dissolution in periimplant plaque at 8 weeks following treatment quantified using inductively coupled mass spectrometry (ICMS) | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Probing depth reduction | Probing depth reduction following surgical peri-implant treatment | 5 months, 12 months |
| BOP reduction | Changes in % bleeding on probing following surgical peri-implant treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Georgios Kotsakis, DDS, MS | Assistant Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UTHealth San Antonio | San Antonio | Texas | 78229 | United States | ||
| University of Washington, Department of Periodontics |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37070363 | Result | Daubert D, Lee E, Botto A, Eftekhar M, Palaiologou A, Kotsakis GA. Assessment of titanium release following non-surgical peri-implantitis treatment: A randomized clinical trial. J Periodontol. 2023 Sep;94(9):1122-1132. doi: 10.1002/JPER.22-0716. Epub 2023 May 2. | |
| 42316309 | Derived | Kotsakis GA, Botto A, Jazaeri MS, Palaiologou A, Lee E, Daubert DM. Impact of abrasive versus non-abrasive cleaning on peri-implantitis titanium release: A randomized clinical trial. J Periodontol. 2026 Jun 18. doi: 10.1002/jper.70158. Online ahead of print. |
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| ID | Term |
|---|---|
| D057873 | Peri-Implantitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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Participants will not know which intervention was administered. Outcome assessor will be different than care provider and will be masked.
| Implant-specific treatment |
| Other |
Implant brush |
|
| 5 months, 12 months |
| Bone level changes | Changes in peri-implant bone level as assessed via standardized radiographs | 5 months, 12 months |
| Seattle |
| Washington |
| 98195 |
| United States |