Dental Hygiene and Peri-Implant Tissues Homeostasis Ancillary Study

Study Overview
=================
Brief Summary
-----------------
Peri-implantitis is an inflammatory disease that leads to loss of jawbone around dental implants. Recent discoveries have identified increased release of Titanium (Ti) particles around implants as being associated to peri-implantitis. In this ancillary study to the Dental Hygiene and Peri-Implant Tissues Homeostasis trial the objective is to determine potential triggers of increased Ti dissolution from the implant surface and the mechanisms by which Ti dissolution products amplify peri-implant inflammation. Results from this study will determine whether there is a differential response to Ti particles across individuals, which may alter susceptibility to peri-implantitis.

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

Conditions
-----------------
Peri-Implantitis

Intervention / Treatment
-----------------
* Procedure: Peri-implantitis debridement
* Other: Dental hygiene procedures


Participation Criteria
=================
Eligibility Criteria
-----------------
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
-----------------
Minimum Age: 25 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tooth-borne treatment<br>Titanium curettes | Procedure: Peri-implantitis debridement<br>* Mechanical cleaning of titanium implants, peri-implantitis debridement.<br>Other: Dental hygiene procedures<br>* Titanium scalers and nylon brushed used for implant cleaning<br>|
| Experimental: Implant-specific treatment<br>Implant brush | Procedure: Peri-implantitis debridement<br>* Mechanical cleaning of titanium implants, peri-implantitis debridement.<br>Other: Dental hygiene procedures<br>* Titanium scalers and nylon brushed used for implant cleaning<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Titanium Dissolution | The primary outcome of the clinical trial will be titanium dissolution in periimplant plaque following treatment quantified using inductively coupled mass spectrometry (ICMS) | 12 weeks +/- 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expression of pro-inflammatory cytokines in response to titanium | We will determine whether PBMCs from peri-implantitis persons and controls have a differential pro-inflammatory response to titanium particles. | baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
implant, titanium, dental