Dental Hygiene and Peri-Implant Tissues Homeostasis
Primary Purpose
Peri-Implantitis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tooth-borne treatment
Implant-specific treatment
Sponsored by
About this trial
This is an interventional treatment trial for Peri-Implantitis
Eligibility 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?
Sites / Locations
- UTHealth San Antonio
- University of Washington, Department of Periodontics
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Tooth-borne treatment
Implant-specific treatment
Arm Description
A cleaning aid that resembles tooth cleaning instruments and is empirically used for implant surface cleaning.
A cleaning aid that has been specifically designed for implant surface cleaning.
Outcomes
Primary Outcome Measures
Titanium elution
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
Probing depth reduction
Probing depth reduction following surgical peri-implant treatment
BOP reduction
Changes in % bleeding on probing following surgical peri-implant treatment
Bone level changes
Changes in peri-implant bone level as assessed via standardized radiographs
Full Information
NCT ID
NCT03384446
First Posted
December 19, 2017
Last Updated
June 30, 2023
Sponsor
University of Washington
Collaborators
Osteogenics Biomedical
1. Study Identification
Unique Protocol Identification Number
NCT03384446
Brief Title
Dental Hygiene and Peri-Implant Tissues Homeostasis
Official Title
The Role of Dental Hygiene Procedures in Disruption of Healthy Homeostasis in Tissues Surrounding Dental Implants - Phase I
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
November 22, 2017 (Actual)
Primary Completion Date
June 1, 2023 (Actual)
Study Completion Date
June 10, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
Osteogenics Biomedical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peri-Implantitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Participants will not know which intervention was administered. Outcome assessor will be different than care provider and will be masked.
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tooth-borne treatment
Arm Type
Active Comparator
Arm Description
A cleaning aid that resembles tooth cleaning instruments and is empirically used for implant surface cleaning.
Arm Title
Implant-specific treatment
Arm Type
Experimental
Arm Description
A cleaning aid that has been specifically designed for implant surface cleaning.
Intervention Type
Other
Intervention Name(s)
Tooth-borne treatment
Intervention Description
Titanium curettes
Intervention Type
Other
Intervention Name(s)
Implant-specific treatment
Intervention Description
Implant brush
Primary Outcome Measure Information:
Title
Titanium elution
Description
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)
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Probing depth reduction
Description
Probing depth reduction following surgical peri-implant treatment
Time Frame
5 months, 12 months
Title
BOP reduction
Description
Changes in % bleeding on probing following surgical peri-implant treatment
Time Frame
5 months, 12 months
Title
Bone level changes
Description
Changes in peri-implant bone level as assessed via standardized radiographs
Time Frame
5 months, 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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?
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Georgios Kotsakis, DDS, MS
Organizational Affiliation
Assistant Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
UTHealth San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
University of Washington, Department of Periodontics
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
37070363
Citation
Daubert D, Lee E, Botto A, Eftekhar M, Palaiologou A, Kotsakis GA. Assessment of titanium release following non-surgical peri-implantitis treatment: A randomized clinical trial. J Periodontol. 2023 Sep;94(9):1122-1132. doi: 10.1002/JPER.22-0716. Epub 2023 May 2.
Results Reference
result
Learn more about this trial
Dental Hygiene and Peri-Implant Tissues Homeostasis
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