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Dental Hygiene and Peri-Implant Tissues Homeostasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03384446
Recruitment Status : Active, not recruiting
First Posted : December 27, 2017
Last Update Posted : November 14, 2022
Sponsor:
Collaborator:
Osteogenics Biomedical
Information provided by (Responsible Party):
Giorgios Kotsakis, University of Washington

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Peri-Implantitis Other: Tooth-borne treatment Other: Implant-specific treatment Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Participants will not know which intervention was administered. Outcome assessor will be different than care provider and will be masked.
Primary Purpose: Treatment
Official Title: The Role of Dental Hygiene Procedures in Disruption of Healthy Homeostasis in Tissues Surrounding Dental Implants - Phase I
Actual Study Start Date : November 22, 2017
Estimated Primary Completion Date : April 15, 2023
Estimated Study Completion Date : April 15, 2023
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Tooth-borne treatment
A cleaning aid that resembles tooth cleaning instruments and is empirically used for implant surface cleaning.
 Other: Tooth-borne treatment
Titanium curettes
Experimental: Implant-specific treatment
A cleaning aid that has been specifically designed for implant surface cleaning.
 Other: Implant-specific treatment
Implant brush


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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?
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03384446


Locations
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United States, Texas
UTHealth San Antonio
San Antonio, Texas, United States, 78229
United States, Washington
University of Washington, Department of Periodontics
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
Osteogenics Biomedical
Investigators
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Principal Investigator: Georgios Kotsakis, DDS, MS Assistant Professor
More Information
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Responsible Party: Giorgios Kotsakis, Assistant Professor, School of Dentistry:Dept. of Periodontics, University of Washington
ClinicalTrials.gov Identifier: NCT03384446    
Other Study ID Numbers: STUDY00002852
First Posted: December 27, 2017    Key Record Dates
Last Update Posted: November 14, 2022
Last Verified: November 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Peri-Implantitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases