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CompletedNCT03917264Updated Jul 5, 2023

Dental Hygiene and Peri-Implant Tissues Homeostasis Ancillary Study

An interventional study of Peri-implantitis debridement and Dental hygiene procedures in Peri-Implantitis, sponsored by University of Washington. Completed at 2 sites in United States. Open to participants aged 25 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-05.

Sponsored by University of Washington · Not applicable, Interventional, and Screening

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Nov 2017, registered May 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
25 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Peri-Implantitis

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Keywords

  • implant
  • titanium
  • dental
03

In context

Peri-Implantitis

304 studies on the registry are indexed under Peri-Implantitis; 84 are open to participants now.

This study's enrollment of 34 is below the median of 40 across 182 interventional studies indexed under Peri-Implantitis.

Browse Peri-Implantitis studies →

Lead sponsor

University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.

Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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?
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
34 participants (actual)

Study arms

  • Active comparator
    Tooth-borne treatment

    Titanium curettes

    Procedure: Peri-implantitis debridement · Other: Dental hygiene procedures

  • Experimental
    Implant-specific treatment

    Implant brush

    Procedure: Peri-implantitis debridement · Other: Dental hygiene procedures

Interventions

  • ProcedurePeri-implantitis debridement

    Mechanical cleaning of titanium implants, peri-implantitis debridement.

  • OtherDental hygiene procedures

    Titanium scalers and nylon brushed used for implant cleaning

06

What researchers measure

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)

    Time frame: 12 weeks +/- 4 weeks

Secondary outcomes

  1. 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.

    Time frame: baseline

07

Study locations

2 sites
  • UTHealth San Antonio
    San Antonio, Texas 78229, United States
  • University of Washington School of Dentistry
    Seattle, Washington 98155, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 5, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03917264
Lead sponsor
University of Washington
Collaborators
Royalty Research Fund - University of Washington
Responsible party
Giorgios Kotsakis (Affiliate Associate Professor, University of Washington) — Principal investigator
First posted
Apr 17, 2019
Start date
Nov 22, 2017
Primary completion
Jun 1, 2023
Completion
Jun 1, 2023
Last update
Jul 5, 2023

Study contacts

Georgios Kotsakis, DDS, MS
principal investigator · UTHealth San Antonio

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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