Clinical trial NCT03753464: The Role of Functional Epigenetic Modifications in Peri-Implantitis
Official title: The Role of Functional Epigenetic Modifications in Peri-Implantitis: A Pilot Clinical Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periimplantitis
Lead sponsor: NYU College of Dentistry
Sponsor class: OTHER
First posted: 2018-11-27
Enrollment: 15
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Periodontally Healthy Subjects
* Peri-implantitis Subjects

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.

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:

* 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:

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.
* 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:

In addition to the general exclusion criteria, subjects allocated to the healthy group who meet any of the following criteria will be excluded from participation in this study:

• 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:

In addition to the general exclusion criteria, subjects allocated to the PIT group who meet any of the following criteria will be excluded from participation in this study:

* 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.

Primary outcomes:
measure: 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)
timeFrame: 6 months
measure: 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.
timeFrame: 6 months
Secondary outcomes:
measure: Visual Analog Scale (VAS) will be assessed to determinate patient-reported outcome measures, at baseline and at 6 months.
timeFrame: 6 months
measure: Oral Health Impact Profile-14 (OHIP-14) will be assessed to determinate patient-reported outcome measures, at baseline and at 6 months.
timeFrame: 6 months
measure: Changes in peri-implant pocket depths (PPD) (in mm) from baseline to 6 month after surgery (only peri-implantitis group).
timeFrame: 6 months
measure: Changes in peri-implant BOP (in percentage), from baseline to 6 month after surgery (only peri-implantitis group).
timeFrame: 6 months
measure: Percentage of peri-implant pocket closure at to 6 month after surgery (only peri-implantitis group).
timeFrame: 6 months
measure: Changes in peri-implant marginal bone level (in mm) from baseline to 6 month after surgery (only peri-implantitis group).
timeFrame: 6 months
measure: Change in soft tissue levels (in mm) from baseline to 6 month after surgery (only peri-implantitis group).
timeFrame: 6 months
measure: Incidence of post-operative surgical site infections (only peri-implantitis group).
timeFrame: 6 months
measure: Incidence of post-operative complications (only peri-implantitis group).
timeFrame: 6 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Bluestone Center for Clinical Research. New York University College of Dentistry
state: New York
Study officials:
affiliation: New York University
name: Ismael Khouly, DDS, MS, PhD
role: PRINCIPAL_INVESTIGATOR
References: