Dental Hygiene and Peri-Implant Tissues Homeostasis

Study Overview
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Brief Summary
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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.

Official Title
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The Role of Dental Hygiene Procedures in Disruption of Healthy Homeostasis in Tissues Surrounding Dental Implants - Phase I

Conditions
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Peri-Implantitis

Intervention / Treatment
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* Other: Tooth-borne treatment
* Other: Implant-specific treatment


Participation Criteria
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Eligibility Criteria
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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?

Ages Eligible for Study
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Minimum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tooth-borne treatment<br>A cleaning aid that resembles tooth cleaning instruments and is empirically used for implant surface cleaning. | Other: Tooth-borne treatment<br>* Titanium curettes<br>|
| Experimental: Implant-specific treatment<br>A cleaning aid that has been specifically designed for implant surface cleaning. | Other: Implant-specific treatment<br>* Implant brush<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 5 months, 12 months | 
| Bone level changes | Changes in peri-implant bone level as assessed via standardized radiographs | 5 months, 12 months |