Dental Hygiene and Peri-Implant Tissues Homeostasis Ancillary Study

June 30, 2023 updated by: Giorgios Kotsakis, University of Washington

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Georgios Kotsakis, DDS, MS
  • Phone Number: 206-616-9412
  • Email: kotsakis@uw.edu

Study Contact Backup

  • Name: Diane Daubert, RDH, PhD
  • Phone Number: 206-685-3766
  • Email: ddaubert@uw.edu

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78229
        • UTHealth San Antonio
    • Washington
      • Seattle, Washington, United States, 98155
        • University of Washington School of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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?

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
12 weeks +/- 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

Royalty Research Fund - University of Washington

Investigators

  • Principal Investigator: Georgios Kotsakis, DDS, MS, UTHealth San Antonio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 22, 2017

Primary Completion (Actual)

June 1, 2023

Study Completion (Actual)

June 1, 2023

Study Registration Dates

First Submitted

May 1, 2018

First Submitted That Met QC Criteria

April 15, 2019

First Posted (Actual)

April 17, 2019

Study Record Updates

Last Update Posted (Actual)

July 5, 2023

Last Update Submitted That Met QC Criteria

June 30, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00002852A

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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