The Role of Functional Epigenetic Modifications in Peri-Implantitis

NCT03753464 | Completed

• 1 other identifier: 18-00986
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Periimplantitis

Outcome Measures

Primary Outcomes (2)

• 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)

  Gingival and blood samples collected from healthy subjects and subjects with peri-implantitis will be used to determinate epigenetic signatures associated with peri-implantitis.

  6 months

• 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.

  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)

  6 months

Secondary Outcomes (9)

• Visual Analog Scale (VAS) will be assessed to determinate patient-reported outcome measures, at baseline and at 6 months.

  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 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

• Percentage of peri-implant pocket closure at to 6 month after surgery (only peri-implantitis group).

  6 months

Study Arms (2)

Peri-implantitis

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

Procedure: Gingival biopsy and blood sample collection

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.

Procedure: Gingival biopsy and blood sample collection

Interventions

Gingival biopsy and blood sample collection PROCEDURE

Gingival and blood samples will be collected.

Healthy; Peri-implantitis

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* Periodontally Healthy Subjects * Peri-implantitis Subjects

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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.
• Inadequate implant position (i.e., prosthetically driven).
• PIT due to excess of cement.

Sponsors & Collaborators

• NYU College of Dentistry: lead

Study Sites (1)

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

New York, New York, 10010-4086, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Gingival and blood samples

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Ismael Khouly, DDS, MS, PhD

  New York University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor, Department of Oral & Maxillofacial Surgery

Study Record Dates

• First Submitted: November 15, 2018
• First Posted: November 27, 2018
• Study Start: October 4, 2018
• Primary Completion: July 2, 2019
• Study Completion: July 2, 2019
• Last Updated: July 3, 2024

Record last verified: 2024-07

Locations

US (1)