The Role of Functional Epigenetic Modifications in Peri-Implantitis

NCT ID: NCT03753464

Last Updated: 2024-07-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 15 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-10-04
• Study Completion Date: 2019-07-02

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.

Conditions

Periimplantitis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Peri-implantitis

Patients undergoing surgical treatment for peri-implantitis. Gingival and blood samples will be collected during the treatment for peri-implantitis.

Gingival biopsy and blood sample collection

Intervention Type: PROCEDURE

Gingival and blood samples will be collected.

Healthy

Healthy patients undergoing treatment for either wisdom tooth extraction or gingivectomy. Gingival and blood samples will be collected during either wisdom tooth extraction or gingivectomy.

Gingival biopsy and blood sample collection

Intervention Type: PROCEDURE

Gingival and blood samples will be collected.

Interventions

Gingival biopsy and blood sample collection

Gingival and blood samples will be collected.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• 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.

• Subjects with implant-supported prosthesis/es in function for at least 12 months who had at least one implant diagnosed with peri-implantitis based on the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions.
• Subjects must be committed to the study and the required follow-up visits.
• Standard of care treatment of the diseased implant with PID will consist on open flap debridement (OFD).

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.
• Subjects with any untreated endodontic lesions or untreated periodontal disease adjacent to the biopsy site.
• Acute necrotizing ulcerative gingivitis or gross tooth decay, as determined by the investigator.
• Subjects with conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis.

Periodontally Healthy Subjects Exclusion:

• Root fragments, pericoronitis, endo-perio lesions, gross tooth decay, or other dental abscesses at the biopsy site. Subjects may be rescreened after resolution of these dental conditions.

Peri-implantitis subjects Exclusion:

• Inadequate implant position (i.e., prosthetically driven).
• PIT due to excess of cement.
• Subjects who have physical or mental handicaps that would interfere with the ability to perform adequate oral hygiene.
• Subjects with implants previously surgically treated for PIT.
• Less than 2mm of keratinized peri-implant tissue.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

NYU College of Dentistry

OTHER

Sponsor Role: lead

Responsible Party

Ismael Khouly

Clinical Assistant Professor, Department of Oral & Maxillofacial Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ismael Khouly, DDS, MS, PhD

Role: PRINCIPAL_INVESTIGATOR

New York University

Locations

Bluestone Center for Clinical Research. New York University College of Dentistry

New York, New York, United States

Countries

United States

Other Identifiers

18-00986

Identifier Type: -

Identifier Source: org_study_id