Dental Hygiene and Peri-Implant Tissues Homeostasis Ancillary Study

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03917264

Enrollment

Registered

2019-04-17

Start date

2017-11-22

Completion date

2023-06-01

Last updated

2023-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peri-Implantitis

Keywords

implant, titanium, dental

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.

Interventions

PROCEDUREPeri-implantitis debridement

Mechanical cleaning of titanium implants, peri-implantitis debridement.

OTHERDental hygiene procedures

Titanium scalers and nylon brushed used for implant cleaning

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

25 Years to No maximum

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

\- 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?

Design outcomes

Primary

Measure	Time frame	Description
Titanium Dissolution	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

Measure	Time frame	Description
Expression of pro-inflammatory cytokines in response to titanium	baseline	We will determine whether PBMCs from peri-implantitis persons and controls have a differential pro-inflammatory response to titanium particles.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026