Dental Hygiene and Peri-Implant Tissues Homeostasis

Peri-Implantitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03384446
• Other study ID #: STUDY00002852
• Status: Completed
• Phase: N/A
• Start date: November 22, 2017
• Est. completion date: June 10, 2023

Study information

• Verified date: June 2023
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: June 10, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years and older

Eligibility

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?

Related Conditions & MeSH terms

• Peri-Implantitis

Intervention

Other:
• Tooth-borne treatment
Titanium curettes
• Implant-specific treatment
Implant brush

Locations

Country	Name	City	State
United States	UTHealth San Antonio	San Antonio	Texas
United States	University of Washington, Department of Periodontics	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	Osteogenics Biomedical

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 Apr 18. doi: 10.1002/JPER.22-0716. Online ahead of print. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	8 weeks
Secondary	Probing depth reduction	Probing depth reduction following surgical peri-implant treatment	5 months, 12 months
Secondary	BOP reduction	Changes in % bleeding on probing following surgical peri-implant treatment	5 months, 12 months
Secondary	Bone level changes	Changes in peri-implant bone level as assessed via standardized radiographs	5 months, 12 months