Clinical trial NCT03384446: 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
Overall status: COMPLETED
Phase: NA
Conditions: Peri-Implantitis
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Osteogenics Biomedical
First posted: 2017-12-27
Enrollment: 34
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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?

Primary outcomes:
measure: Titanium elution
timeFrame: 8 weeks
Secondary outcomes:
measure: Probing depth reduction
timeFrame: 5 months, 12 months
measure: BOP reduction
timeFrame: 5 months, 12 months
measure: Bone level changes
timeFrame: 5 months, 12 months
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: UTHealth San Antonio
state: Texas
city: Seattle
country: United States
facility: University of Washington, Department of Periodontics
state: Washington
Study officials:
affiliation: Assistant Professor
name: Georgios Kotsakis, DDS, MS
role: PRINCIPAL_INVESTIGATOR
References:
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.