NCT03753464

The Role of Functional Epigenetic Modifications in Peri-Implantitis

The Role of Functional Epigenetic Modifications in Peri-Implantitis: A Pilot Clinical Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 15 (actual)
• Sponsor: NYU College of Dentistry · Academic / Other
• Sex: All
• Age: 20 Years – 90 Years
• Healthy volunteers: Accepted

Summary

The aim of this pilot, exploratory, single blind clinical trial is to evaluate the epigenetic changes associated with peri-implantitis.

Detailed description

Twenty patients will be voluntarily enrolled in two groups: 10 healthy participants, and 10 participants with peri-implantitis. Periodontal and peri-implant clinical and radiographic measurements, as well as body mass index, medical and dental history will be recorded within the following timelines: at baseline (for both groups), and 6 months after baseline for the peri-implantitis group only. At baseline, gingival biopsies and blood will be harvested from: a) healthy gingival sites during either surgical removal of wisdom teeth or gingivoplasty, in the healthy group; and, b) from a peri-implantitis site during surgical treatment of peri-implantitis, and when possible, from a healthy gingival site within the same participant, in the peri-implantitis group. After harvesting of biopsies, peri-implantitis subjects will be re-evaluated 6 months after treatment. During the 6-month visit, if a second surgical treatment of peri-implantitis in the same implant treated at baseline is indicated as standard of care of the participant, a new gingiva biopsy and blood will be collected. Gingival biopsies and blood collected from each participant will be used to perform DNA methylation analysis.

Conditions

• Periimplantitis

Interventions

Type	Name	Description
PROCEDURE	Gingival biopsy and blood sample collection	Gingival and blood samples will be collected.

Timeline

• Start date: 2018-10-04
• Primary completion: 2019-07-02
• Completion: 2019-07-02
• First posted: 2018-11-27
• Last updated: 2024-07-03

Locations

1 site across 1 country: United States