Dental Hygiene and Peri-Implant Tissues Homeostasis

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

2023-06-10

Brief Summary

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Dental implants have revolutionized the field of dentistry, providing improvements in function and esthetics. They are not, however, without risks. Bone loss around implants (i.e. periimplantitis) is an emerging public health concern. Untreated, peri-implantitis leads to implant loss and jawbone defects. Nonetheless, existing therapies have failed to show long-term efficacy. The pathogenesis of peri-implantitis is believed to be of bacterial etiology similar to periodontal disease. Therefore, existing treatments duplicate strategies for the treatment of natural teeth. However, the titanium (Ti) surface of implants is quite dissimilar to teeth. Recent work from our lab has demonstrated that peri-implantitis is associated with increased release of Ti particles around implants. These findings suggest that treatments targeting periimplantitis must be designed around Ti material properties. A gap in knowledge exists regarding the potential triggers of increased Ti dissolution from the implant surface and the mechanisms by which Ti dissolution products amplify peri-implant inflammation. The aim of this study is to determine if the use of tooth-driven treatment approaches increase Ti in the submucosal plaque.

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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

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Participants will not know which intervention was administered. Outcome assessor will be different than care provider and will be masked.

Study Groups

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Tooth-borne treatment

A cleaning aid that resembles tooth cleaning instruments and is empirically used for implant surface cleaning.

Group Type ACTIVE_COMPARATOR

Tooth-borne treatment

Intervention Type OTHER

Titanium curettes

Implant-specific treatment

A cleaning aid that has been specifically designed for implant surface cleaning.

Group Type EXPERIMENTAL

Implant-specific treatment

Intervention Type OTHER

Implant brush

Interventions

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Tooth-borne treatment

Titanium curettes

Intervention Type OTHER

Implant-specific treatment

Implant brush

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