Peri-Implantitis
Conditions
Brief summary
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.
Interventions
OTHERTooth-borne treatment
Titanium curettes
OTHERImplant-specific treatment
Implant brush
Sponsors
Osteogenics Biomedical
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants will not know which intervention was administered. Outcome assessor will be different than care provider and will be masked.
Eligibility
Sex/Gender
ALL
Age
25 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Is the subject ≥ 25 years of age? * Does the subject have an implant with a probing depth ≥ 5mm, bleeding on probing, and radiographic bone loss of \> 2mm? * Is the subject committed to the study and the required follow-up visits?
Exclusion criteria
* Is the subject immune compromised? * Is the subject diabetic? * Does the subject take steroid medication? * Does the subject regularly use non-steroidal anti-inflammatories? * Is the subject pregnant or intending to become pregnant during the duration of the study? * Has the subject had previous implantoplasty? * Did the subject take any antibiotics in the last 3 months?
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Titanium elution | 8 weeks | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Probing depth reduction | 5 months, 12 months | Probing depth reduction following surgical peri-implant treatment |
| BOP reduction | 5 months, 12 months | Changes in % bleeding on probing following surgical peri-implant treatment |
| Bone level changes | 5 months, 12 months | Changes in peri-implant bone level as assessed via standardized radiographs |
Countries
United States
Outcome results
None listed