Skip to main content
OpenTrials
Completed

NCT Number: NCT03917264

Dental Hygiene and Peri-Implant Tissues Homeostasis 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Peri-implantitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

25 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UTHealth San Antonio, San Antonio, Texas, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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?

Treatment and study plan

Peri-implantitis debridement

Procedure

Mechanical cleaning of titanium implants, peri-implantitis debridement.

Dental hygiene procedures

Other

Titanium scalers and nylon brushed used for implant cleaning

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • Royalty Research Fund - University of Washington

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Apr 17, 2019
Registry last updated
Jul 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.