The Role of Functional Epigenetic Modifications in Peri-Implantitis: A Pilot Clinical Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Periimplantitis
- Sponsor
- NYU College of Dentistry
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Differences in epigenetic signatures in peri-implantitis subjects as compared to healthy subjects, in an exploratory manner. (Gingival biopsies and blood collected to perform DNA methylation analysis)
- Status
- Completed
- Last Updated
- last year
Overview
Brief 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.
Investigators
Ismael Khouly
Clinical Assistant Professor, Department of Oral & Maxillofacial Surgery
NYU College of Dentistry
Eligibility Criteria
Inclusion Criteria
- •General Inclusion Criteria:
- •Subjects must have read, understood, and signed an informed consent form.
- •Subjects must be 20-90 years of age.
- •Subjects must be non-smokers or ex-smokers who have quit smoking for at least one year prior to enrollment in the study.
- •Subjects must be in good general health as assessed by the Investigator.
- •Healthy Periodontal Subjects Inclusion Criteria:
- •In addition to the general inclusion criteria, a healthy periodontal subject must meet all of the following criteria:
- •Subjects show gingival health and no history of periodontitis, as described in the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions.
- •Peri-implantitis Subjects Inclusion Criteria:
- •In addition to the general inclusion criteria, a PIT subject must meet all of the following criteria:
Exclusion Criteria
- •General Exclusion Criteria:
- •Pregnant or lactating.
- •Use of antibiotics, within 1 month before enrollment in the study.
- •Chronic use of nonsteroidal anti-inflammatory drugs for over 3 weeks of continuous use at the time of enrollment or during the course of the study.
- •Requirement for prophylactic antibiotics for dental procedures.
- •Mucosal diseases in the localized area around the biopsy site.
- •Subjects with a systemic disease that would preclude biopsy/oral surgery.
- •History of local irradiation therapy in the head/neck area.
- •Subjects with poor oral hygiene.
- •Subjects receiving, or having a history of receiving intravenous or subcutaneous anti-resorptive agents associated with osteonecrosis of the jaw.
Outcomes
Primary Outcomes
Differences in epigenetic signatures in peri-implantitis subjects as compared to healthy subjects, in an exploratory manner. (Gingival biopsies and blood collected to perform DNA methylation analysis)
Time Frame: 6 months
Gingival and blood samples collected from healthy subjects and subjects with peri-implantitis will be used to determinate epigenetic signatures associated with peri-implantitis.
Epigenetic signatures associated with response to treatment peri-implantitis at 6 months, in an exploratory manner. (Differences in epigenetic signatures in peri-implantitis subjects as compared to healthy subjects, in an exploratory manner.
Time Frame: 6 months
Samples collected from patients with peri-implantitis will be used to determinate epigenetic signatures associated response to treatment peri-implantitis at 6 months. (Gingival biopsies and blood collected to perform DNA methylation analysis)
Secondary Outcomes
- Changes in peri-implant pocket depths (PPD) (in mm) from baseline to 6 month after surgery (only peri-implantitis group).(6 months)
- Changes in peri-implant BOP (in percentage), from baseline to 6 month after surgery (only peri-implantitis group).(6 months)
- Visual Analog Scale (VAS) will be assessed to determinate patient-reported outcome measures, at baseline and at 6 months.(6 months)
- Incidence of post-operative complications (only peri-implantitis group).(6 months)
- Oral Health Impact Profile-14 (OHIP-14) will be assessed to determinate patient-reported outcome measures, at baseline and at 6 months.(6 months)
- Changes in peri-implant marginal bone level (in mm) from baseline to 6 month after surgery (only peri-implantitis group).(6 months)
- Incidence of post-operative surgical site infections (only peri-implantitis group).(6 months)
- Percentage of peri-implant pocket closure at to 6 month after surgery (only peri-implantitis group).(6 months)
- Change in soft tissue levels (in mm) from baseline to 6 month after surgery (only peri-implantitis group).(6 months)