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Dental Hygiene and Peri-Implant Tissues Homeostasis Ancillary Study

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ClinicalTrials.gov Identifier: NCT03917264
Recruitment Status : Recruiting
First Posted : April 17, 2019
Last Update Posted : April 17, 2019
Sponsor:
Collaborator:
Royalty Research Fund - University of Washington
Information provided by (Responsible Party):
Giorgios Kotsakis, University of Washington

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.

Condition or disease Intervention/treatment Phase
Peri-Implantitis Procedure: Peri-implantitis debridement Other: Dental hygiene procedures Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Screening
Official Title: The Role of Dental Hygiene Procedures in Disruption of Healthy Homeostasis in Tissues Surrounding Dental Implants - Phase I (Ancillary Study)
Actual Study Start Date : November 22, 2017
Estimated Primary Completion Date : November 21, 2019
Estimated Study Completion Date : February 21, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dental Health

Arm Intervention/treatment
Active Comparator: Tooth-borne treatment
Titanium curettes
Procedure: Peri-implantitis debridement
Mechanical cleaning of titanium implants, peri-implantitis debridement.

Other: Dental hygiene procedures
Titanium scalers and nylon brushed used for implant cleaning

Experimental: Implant-specific treatment
Implant brush
Procedure: Peri-implantitis debridement
Mechanical cleaning of titanium implants, peri-implantitis debridement.

Other: Dental hygiene procedures
Titanium scalers and nylon brushed used for implant cleaning




Primary Outcome Measures :
  1. Titanium Dissolution [ Time Frame: 12 weeks +/- 4 weeks ]
    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 :
  1. Expression of pro-inflammatory cytokines in response to titanium [ Time Frame: baseline ]
    We will determine whether PBMCs from peri-implantitis persons and controls have a differential pro-inflammatory response to titanium particles.



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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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?


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03917264


Contacts
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Contact: Georgios Kotsakis, DDS, MS 206-616-9412 kotsakis@uw.edu
Contact: Diane Daubert, RDH, PhD 206-685-3766 ddaubert@uw.edu

Locations
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United States, Washington
University of Washington School of Dentistry Recruiting
Seattle, Washington, United States, 98155
Contact: Georgios Kotsakis, DDS         
Sponsors and Collaborators
University of Washington
Royalty Research Fund - University of Washington
Investigators
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Principal Investigator: Georgios Kotsakis, DDS, MS University of Washington

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Responsible Party: Giorgios Kotsakis, Affiliate Associate Professor, University of Washington
ClinicalTrials.gov Identifier: NCT03917264     History of Changes
Other Study ID Numbers: STUDY00002852A
First Posted: April 17, 2019    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Giorgios Kotsakis, University of Washington:
implant
titanium
dental

Additional relevant MeSH terms:
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Peri-Implantitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases