Back to resultsDental Hygiene and Peri-Implant Tissues Homeostasis Ancillary Study
Primary Purpose
Peri-Implantitis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Peri-implantitis debridement
Dental hygiene procedures
Sponsored by
About this trial
This is an interventional screening trial for Peri-Implantitis focused on measuring implant, titanium, dental
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?
Sites / Locations
- UTHealth San Antonio
- University of Washington School of Dentistry
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Tooth-borne treatment
Implant-specific treatment
Arm Description
Titanium curettes
Implant brush
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT03917264
First Posted
May 1, 2018
Last Updated
June 30, 2023
Sponsor
University of Washington
Collaborators
Royalty Research Fund - University of Washington
1. Study Identification
Unique Protocol Identification Number
NCT03917264
Brief Title
Dental Hygiene and Peri-Implant Tissues Homeostasis Ancillary Study
Official Title
The Role of Dental Hygiene Procedures in Disruption of Healthy Homeostasis in Tissues Surrounding Dental Implants - Phase I (Ancillary Study)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
November 22, 2017 (Actual)
Primary Completion Date
June 1, 2023 (Actual)
Study Completion Date
June 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
Royalty Research Fund - University of Washington
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peri-Implantitis
Keywords
implant, titanium, dental
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tooth-borne treatment
Arm Type
Active Comparator
Arm Description
Titanium curettes
Arm Title
Implant-specific treatment
Arm Type
Experimental
Arm Description
Implant brush
Intervention Type
Procedure
Intervention Name(s)
Peri-implantitis debridement
Intervention Description
Mechanical cleaning of titanium implants, peri-implantitis debridement.
Intervention Type
Other
Intervention Name(s)
Dental hygiene procedures
Intervention Description
Titanium scalers and nylon brushed used for implant cleaning
Primary Outcome Measure Information:
Title
Titanium Dissolution
Description
The primary outcome of the clinical trial will be titanium dissolution in periimplant plaque following treatment quantified using inductively coupled mass spectrometry (ICMS)
Time Frame
12 weeks +/- 4 weeks
Secondary Outcome Measure Information:
Title
Expression of pro-inflammatory cytokines in response to titanium
Description
We will determine whether PBMCs from peri-implantitis persons and controls have a differential pro-inflammatory response to titanium particles.
Time Frame
baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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?
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Georgios Kotsakis, DDS, MS
Organizational Affiliation
UTHealth San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
UTHealth San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
University of Washington School of Dentistry
City
Seattle
State/Province
Washington
ZIP/Postal Code
98155
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Dental Hygiene and Peri-Implant Tissues Homeostasis Ancillary Study
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