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Dental Hygiene and Peri-Implant Tissues Homeostasis

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University of Washington

Status

Completed

Conditions

Peri-Implantitis

Treatments

Other: Tooth-borne treatment
Other: Implant-specific treatment

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03384446
STUDY00002852

Details and patient eligibility

About

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.

Enrollment

34 patients

Sex

All

Ages

25+ years old

Volunteers

Accepts Healthy Volunteers

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?

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

34 participants in 2 patient groups

Tooth-borne treatment
Active Comparator group
Description:
A cleaning aid that resembles tooth cleaning instruments and is empirically used for implant surface cleaning.
Treatment:
Other: Tooth-borne treatment
Implant-specific treatment
Experimental group
Description:
A cleaning aid that has been specifically designed for implant surface cleaning.
Treatment:
Other: Implant-specific treatment

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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