Dental Hygiene and Peri-Implant Tissues Homeostasis Ancillary Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-22

Study Completion Date

2023-06-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Peri-Implantitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Tooth-borne treatment

Titanium curettes

Group Type ACTIVE_COMPARATOR

Peri-implantitis debridement

Intervention Type PROCEDURE

Mechanical cleaning of titanium implants, peri-implantitis debridement.

Dental hygiene procedures

Intervention Type OTHER

Titanium scalers and nylon brushed used for implant cleaning

Implant-specific treatment

Implant brush

Group Type EXPERIMENTAL

Peri-implantitis debridement

Intervention Type PROCEDURE

Mechanical cleaning of titanium implants, peri-implantitis debridement.

Dental hygiene procedures

Intervention Type OTHER

Titanium scalers and nylon brushed used for implant cleaning

Interventions

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Peri-implantitis debridement

Mechanical cleaning of titanium implants, peri-implantitis debridement.

Intervention Type PROCEDURE

Dental hygiene procedures

Titanium scalers and nylon brushed used for implant cleaning

Intervention Type OTHER

Eligibility Criteria

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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?

Minimum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes