Dental Hygiene and Peri-Implant Tissues Homeostasis

Not Applicable

Completed

• Conditions: Peri-Implantitis
• Interventions: Other: Tooth-borne treatment; Other: Implant-specific treatment

• Registration Number: NCT03384446
• Lead Sponsor: University of Washington

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 available

Study Timeline

• Study Start: 2017-11-22
• Study First Submitted: 2017-12-19
• Study First Submitted QC: 2017-12-24
• Study First Posted: 2017-12-27
• Status Verified: 2023-06
• Primary Completion: 2023-06-01
• Study Completion: 2023-06-10
• Last Update Submitted: 2023-06-30
• Last Update Posted: 2023-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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?

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tooth-borne treatment	Tooth-borne treatment	A cleaning aid that resembles tooth cleaning instruments and is empirically used for implant surface cleaning.
Implant-specific treatment	Implant-specific treatment	A cleaning aid that has been specifically designed for implant surface cleaning.

Primary Outcome Measures

Name	Time	Method
Titanium elution	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

Name	Time	Method
Probing depth reduction	5 months, 12 months	Probing depth reduction following surgical peri-implant treatment
BOP reduction	5 months, 12 months	Changes in % bleeding on probing following surgical peri-implant treatment
Bone level changes	5 months, 12 months	Changes in peri-implant bone level as assessed via standardized radiographs

Trial Locations

Locations (2)

UTHealth San Antonio; 🇺🇸 San Antonio, Texas, United States

University of Washington, Department of Periodontics; 🇺🇸 Seattle, Washington, United States