Dental Hygiene and Peri-Implant Tissues Homeostasis Ancillary Study

Peri-Implantitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03917264
• Other study ID #: STUDY00002852A
• Status: Completed
• Phase: N/A
• Start date: November 22, 2017
• Est. completion date: June 1, 2023

Study information

• Verified date: June 2023
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years and older

Eligibility

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?

Related Conditions & MeSH terms

• Peri-Implantitis

Intervention

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

Locations

Country	Name	City	State
United States	UTHealth San Antonio	San Antonio	Texas
United States	University of Washington School of Dentistry	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	Royalty Research Fund - University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	baseline