Dental Hygiene and Peri-Implant Tissues Homeostasis Ancillary Study

Not Applicable

Completed

• Conditions: Peri-Implantitis
• Interventions: Procedure: Peri-implantitis debridement; Other: Dental hygiene procedures

• Registration Number: NCT03917264
• Lead Sponsor: University of Washington

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-22
• Study First Submitted: 2018-05-01
• Study First Submitted QC: 2019-04-15
• Study First Posted: 2019-04-17
• Status Verified: 2023-06
• Primary Completion: 2023-06-01
• Study Completion: 2023-06-01
• Last Update Submitted: 2023-06-30
• Last Update Posted: 2023-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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?

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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?

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tooth-borne treatment	Peri-implantitis debridement	Titanium curettes
Implant-specific treatment	Peri-implantitis debridement	Implant brush
Implant-specific treatment	Dental hygiene procedures	Implant brush
Tooth-borne treatment	Dental hygiene procedures	Titanium curettes

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

UTHealth San Antonio; 🇺🇸 San Antonio, Texas, United States

University of Washington School of Dentistry; 🇺🇸 Seattle, Washington, United States