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Dental Hygiene and Peri-Implant Tissues Homeostasis

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ClinicalTrials.gov Identifier: NCT03384446
Recruitment Status : Recruiting
First Posted : December 27, 2017
Last Update Posted : November 3, 2020
Sponsor:
Collaborator:
Osteogenics Biomedical
Information provided by (Responsible Party):
Giorgios Kotsakis, University of Washington

Tracking Information
First Submitted Date  ICMJE December 19, 2017
First Posted Date  ICMJE December 27, 2017
Last Update Posted Date November 3, 2020
Actual Study Start Date  ICMJE November 22, 2017
Estimated Primary Completion Date April 15, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 24, 2017)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 24, 2017)
  • Probing depth reduction [ Time Frame: 5 months, 12 months ]
    Probing depth reduction following surgical peri-implant treatment
  • BOP reduction [ Time Frame: 5 months, 12 months ]
    Changes in % bleeding on probing following surgical peri-implant treatment
  • Bone level changes [ Time Frame: 5 months, 12 months ]
    Changes in peri-implant bone level as assessed via standardized radiographs
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dental Hygiene and Peri-Implant Tissues Homeostasis
Official Title  ICMJE The Role of Dental Hygiene Procedures in Disruption of Healthy Homeostasis in Tissues Surrounding Dental Implants - Phase I
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Peri-Implantitis
Intervention  ICMJE
  • Other: Tooth-borne treatment
    Titanium curettes
  • Other: Implant-specific treatment
    Implant brush
Study Arms  ICMJE
  • Active Comparator: Tooth-borne treatment
    A cleaning aid that resembles tooth cleaning instruments and is empirically used for implant surface cleaning.
    Intervention: Other: Tooth-borne treatment
  • Experimental: Implant-specific treatment
    A cleaning aid that has been specifically designed for implant surface cleaning.
    Intervention: Other: Implant-specific treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 24, 2017)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 15, 2022
Estimated Primary Completion Date April 15, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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?
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Georgios Kotsakis, DDS, MS 206.616.9412 kotsakis@uw.edu
Contact: Diane Daubert, RDH, PhD ddaubert@uw.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03384446
Other Study ID Numbers  ICMJE STUDY00002852
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Giorgios Kotsakis, University of Washington
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Washington
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Osteogenics Biomedical
Investigators  ICMJE
Principal Investigator: Georgios Kotsakis, DDS, MS Assistant Professor
PRS Account University of Washington
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP