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OpenTrials
Completed

NCT Number: NCT03384446

Dental Hygiene and Peri-Implant Tissues Homeostasis

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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Key information

Age range

25 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UTHealth San Antonio, San Antonio, Texas, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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?

Treatment and study plan

Tooth-borne treatment

Other

Titanium curettes

Implant-specific treatment

Other

Implant brush

Primary outcomes

  1. Titanium elution

    Time frame: 8 weeks

    The primary outcome of the clinical trial will be titanium dissolution in periimplant plaque at 8 weeks following treatment quantified using inductively coupled mass spectrometry (ICMS)

Secondary outcomes

  1. Probing depth reduction

    Time frame: 5 months, 12 months

    Probing depth reduction following surgical peri-implant treatment

  2. BOP reduction

    Time frame: 5 months, 12 months

    Changes in % bleeding on probing following surgical peri-implant treatment

  3. Bone level changes

    Time frame: 5 months, 12 months

    Changes in peri-implant bone level as assessed via standardized radiographs

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • Osteogenics Biomedical

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Dec 27, 2017
Registry last updated
Jul 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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