Dental Hygiene and Peri-Implant Tissues Homeostasis Ancillary Study
The Role of Dental Hygiene Procedures in Disruption of Healthy Homeostasis in Tissues Surrounding Dental Implants - Phase I (Ancillary Study)
1 other identifier
interventional
34
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2017
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 22, 2017
CompletedFirst Submitted
Initial submission to the registry
May 1, 2018
CompletedFirst Posted
Study publicly available on registry
April 17, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedJuly 5, 2023
June 1, 2023
5.5 years
May 1, 2018
June 30, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Expression of pro-inflammatory cytokines in response to titanium
baseline
Study Arms (2)
Tooth-borne treatment
ACTIVE COMPARATORTitanium curettes
Implant-specific treatment
EXPERIMENTALImplant brush
Interventions
Mechanical cleaning of titanium implants, peri-implantitis debridement.
Titanium scalers and nylon brushed used for implant cleaning
Eligibility Criteria
You may qualify if:
- 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?
You may not qualify if:
- \- 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?
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
UTHealth San Antonio
San Antonio, Texas, 78229, United States
University of Washington School of Dentistry
Seattle, Washington, 98155, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Georgios Kotsakis, DDS, MS
UTHealth San Antonio
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Affiliate Associate Professor
Study Record Dates
First Submitted
May 1, 2018
First Posted
April 17, 2019
Study Start
November 22, 2017
Primary Completion
June 1, 2023
Study Completion
June 1, 2023
Last Updated
July 5, 2023
Record last verified: 2023-06